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Background: Improving physical activity and reducing sedentary behavior represent important areas for intervention in childhood in order to reduce the burden of chronic disease related to obesity and physical inactivity in later life. This paper aims to determine the cost-effectiveness of a multi-arm primary school-based intervention to increase physical activity and/or reduce sedentary time in 8–9 year old children (Transform-Us!). Methods: Modelled cost-utility analysis, using costs and effects from a cluster randomized controlled trial of a 30-month intervention that used pedagogical and environmental strategies to reduce and break up sedentary behaviour (SB-I), promote physical activity (PA-I), or a combined approach (PA + SB-I), compared to current practice. A validated multiple-cohort lifetable model (ACE-Obesity Policy model) estimated the obesity and physical activity-related health outcomes (measured as change in body mass index and change in metabolic equivalent task minutes respectively) and healthcare cost-savings over the cohort's lifetime from the public-payer perspective, assuming the intervention was delivered to all 8–9 year old children attending Australian Government primary schools. Sensitivity analyses tested the impact on cost-effectiveness of varying key input parameters, including maintenance of intervention effect assumptions. Results: Cost-effectiveness results demonstrated that, when compared to control schools, the PA-I and SB-I intervention arms were "dominant", meaning that they resulted in net health benefits and healthcare cost-savings if the intervention effects were maintained. When the costs and effects of these intervention arms were extrapolated to the Australian population, results suggested significant potential as obesity prevention measures (PA-I: 60,780 HALYs saved (95% UI 15,007-109,413), healthcare cost-savings AUD641M (95% UI AUD165M-$1.1B); SB-I: 61,126 HALYs saved (95% UI 11,770 − 111,249), healthcare cost-savings AUD654M (95% UI AUD126M-1.2B)). The PA-I and SB-I interventions remained cost-effective in sensitivity analysis, assuming the full decay of intervention effect after 10 years. Conclusions: The PA-I and SB-I Transform-Us! intervention arms represent good value for money and could lead to health benefits and healthcare cost-savings arising from the prevention of chronic disease in later life if intervention effects are sustained. Trial registration: International Standard Randomized Controlled Trial Number (ISRCTN83725066). Australia and New Zealand Clinical Trials Registry Number (ACTRN12609000715279). [ABSTRACT FROM AUTHOR]

Background: In many Westernised countries, children do not consume a sufficient amount of vegetables for optimal health and development. Child-feeding guidelines have been produced to address this, but often only promote offering vegetables at midday/evening meals and snack times. With guidance having limited success in increasing children's vegetable intake at a population level, novel approaches to address this must be developed. Offering vegetables to children at breakfast time in nursery/kindergarten settings has the potential to increase children's overall daily vegetable consumption as children typically attend nursery/kindergarten and many routinely eat breakfast there. However, the feasibility and acceptability of this intervention (Veggie Brek) to children and nursery staff has not been investigated. Methods: A feasibility and acceptability cluster randomised controlled trial (RCT) was undertaken in eight UK nurseries. All nurseries engaged in one-week baseline and follow-up phases before and after an intervention/control period. Staff in intervention nurseries offered three raw carrot batons and three cucumber sticks alongside children's main breakfast food each day for three weeks. Control nurseries offered children their usual breakfast. Feasibility was assessed by recruitment data and nursery staff's ability to follow the trial protocol. Acceptability was assessed by children's willingness to eat the vegetables at breakfast time. All primary outcomes were assessed against traffic-light progression criteria. Staff preference for collecting data via photographs versus using paper was also assessed. Further views about the intervention were obtained through semi-structured interviews with nursery staff. Results: The recruitment of parents/caregivers willing to provide consent for eligible children was acceptable at 67.8% (within the amber stop–go criterion) with 351 children taking part across eight nurseries. Both the feasibility and acceptability of the intervention to nursery staff and the willingness of children to consume the vegetables met the green stop–go criteria, with children eating some part of the vegetables in 62.4% (745/1194) of instances where vegetables were offered. Additionally, staff preferred reporting data using paper compared to taking photographs. Conclusions: Offering vegetables to children at breakfast time in nursery/kindergarten settings is feasible and acceptable to children and nursery staff. A full intervention evaluation should be explored via a definitive RCT. Trial registration: NCT05217550. [ABSTRACT FROM AUTHOR]

Background: A cluster randomised controlled trial demonstrated the effectiveness of the SMART Work & Life (SWAL) behaviour change intervention, with and without a height-adjustable desk, for reducing sitting time in desk-based workers. Staff within organisations volunteered to be trained to facilitate delivery of the SWAL intervention and act as workplace champions. This paper presents the experiences of these champions on the training and intervention delivery, and from participants on their intervention participation. Methods: Quantitative and qualitative feedback from workplace champions on their training session was collected. Participants provided quantitative feedback via questionnaires at 3 and 12 month follow-up on the intervention strategies (education, group catch ups, sitting less challenges, self-monitoring and prompts, and the height-adjustable desk [SWAL plus desk group only]). Interviews and focus groups were also conducted at 12 month follow-up with workplace champions and participants respectively to gather more detailed feedback. Transcripts were uploaded to NVivo and the constant comparative approach informed the analysis of the interviews and focus groups. Results: Workplace champions rated the training highly with mean scores ranging from 5.3/6 to 5.7/6 for the eight parts. Most participants felt the education increased their awareness of the health consequences of high levels of sitting (SWAL: 90.7%; SWAL plus desk: 88.2%) and motivated them to change their sitting time (SWAL: 77.5%; SWAL plus desk: 85.77%). A high percentage of participants (70%) reported finding the group catch up session helpful and worthwhile. However, focus groups highlighted mixed responses to the group catch-up sessions, sitting less challenges and self-monitoring intervention components. Participants in the SWAL plus desk group felt that having a height-adjustable desk was key in changing their behaviour, with intrinsic as well as time based factors reported as key influences on the height-adjustable desk usage. In both intervention groups, participants reported a range of benefits from the intervention including more energy, less fatigue, an increase in focus, alertness, productivity and concentration as well as less musculoskeletal problems (SWAL plus desk group only). Work-related, interpersonal, personal attributes, physical office environment and physical barriers were identified as barriers when trying to sit less and move more. Conclusions: Workplace champion and participant feedback on the intervention was largely positive but it is clear that different behaviour change strategies worked for different people indicating that a 'one size fits all' approach may not be appropriate for this type of intervention. The SWAL intervention could be tested in a broader range of organisations following a few minor adaptations based on the champion and participant feedback. Trial registration: ISCRCTN registry (ISRCTN11618007). [ABSTRACT FROM AUTHOR]

Background: The Nutri-Score summary graded front-of-pack nutrition label has been identified as an efficient tool to increase the nutritional quality of pre-packed food purchases. However, no study has been conducted to investigate the effect of the Nutri-Score on the shopping cart composition, considering the type of foods. The present paper aims to investigate the effect of the Nutri-Score on the type of food purchases, in terms of the relative contribution of unpacked and pre-packed foods, or the processing degree of foods. Methods: Between September 2016 and April 2017, three consecutive randomized controlled trials were conducted in three specific populations – students (N = 1866), low-income individuals (N = 336) and subjects suffering from cardiometabolic diseases (N = 1180) – to investigate the effect of the Nutri-Score on purchasing intentions compared to the Reference Intakes and no label. Using these combined data, the proportion of unpacked products in the shopping carts, as well as the distribution of products across food categories taking into account the degree of processing (NOVA classification) were assessed by trials arm. Results: The shopping carts of participants simulating purchases with the Nutri-Score affixed on pre-packed foods contained higher proportion of unpacked products – especially raw fruits and meats, i.e. with no FoPL –, compared to participants purchasing with no label (difference of 5.93 percentage points [3.88–7.99], p-value< 0.0001) or with the Reference Intakes (difference of 5.27[3.25–7.29], p-value< 0.0001). This higher proportion was partly explained by fewer purchases of pre-packed processed and ultra-processed products overall in the Nutri-Score group. Conclusions: These findings provide new insights on the positive effect of the Nutri-Score, which appears to decrease purchases in processed products resulting in higher proportions of unprocessed and unpacked foods, in line with public health recommendations. [ABSTRACT FROM AUTHOR]

Background: 'Physical Activity 4 Everyone' (PA4E1) was an efficacious multi-component school-based physical activity (PA) program targeting adolescents. PA4E1 has seven PA practices. It is essential to scale-up, evaluate effectiveness and assess implementation of such programs. Therefore, the aim is to assess the impact of implementation support on school practice uptake of the PA4E1 program at 12 and 24 months. Methods: A cluster randomised controlled trial, utilising a type III hybrid implementation-effectiveness design, was conducted in 49 randomly selected disadvantaged Australian Government and Catholic secondary schools. A blinded statistician randomly allocated schools to a usual practice control (n = 25) or the PA4E1 program group (n = 24), with the latter receiving seven implementation support strategies to support school PA practice uptake of the seven practices retained from the efficacy trial. The primary outcome was the proportion of schools adopting at least four of the seven practices, assessed via telephone surveys with Head Physical Education Teachers and analysed using exact logistic regression modelling. This paper reports the 12-month outcomes. Results: Schools were recruited from May to November 2017. At baseline, no schools implemented four of the seven practices. At 12 months significantly more schools in the program group had implemented four of the seven practices (16/24, 66.7%) than the control group (1/25, 4%) (OR = 33.0[4.15–1556.4], p < 0.001). The program group implemented on average 3.2 (2.5–3.9) more practices than the control group (p < 0.001, mean 3.9 (SD 1.5) vs 0.7 (1.0)). Fidelity and reach of the implementation support intervention were high (both > 80%). Conclusions: Through the application of multiple implementation support strategies, secondary schools were able to overcome commonly known barriers to implement evidence based school PA practices. As such practices have been shown to result in an increase in adolescent PA and improvements in weight status, policy makers and practitioners responsible for advocating PA in schools should consider this implementation approach more broadly when working with schools. Follow-up is required to determine whether practice implementation is sustained. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12617000681358 registered 12th May 2017. [ABSTRACT FROM AUTHOR]

Background: The few health behavior interventions commencing in infancy have shown promising effects. Greater insight into their longer-term benefits is required. This study aimed to assess post-intervention effects of the Melbourne INFANT Program to child age 5y on diet, movement and adiposity. Methods: Two and 3.5y post-intervention follow-up (2011–13; analyses completed 2019) of participants retained in the Melbourne INFANT Program at its conclusion (child age ~ 19 m; 2008–10) was conducted. The Melbourne INFANT Program is a 15-month, six session program delivered within first-time parent groups in Melbourne, Australia, between child age 4-19 m. It involves strategies to help parents promote healthy diet, physical activity and reduced sedentary behavior in their infants. No intervention was delivered during the follow-up period reported in this paper. At all time points height, weight and waist circumference were measured by researchers, children wore Actigraph and activPAL accelerometers for 8-days, mothers reported children's television viewing and use of health services. Children's dietary intake was reported by mothers in three unscheduled telephone-administered 24-h recalls. Results: Of those retained at program conclusion (child age 18 m, n = 480; 89%), 361 families (75% retention) participated in the first follow-up (2y post-intervention; age 3.6y) and 337 (70% retention) in the second follow-up (3.5y post-intervention; age 5y). At 3.6y children in the intervention group had higher fruit (adjusted mean difference [MD] = 25.34 g; CI95:1.68,48.99), vegetable (MD = 19.41; CI95:3.15,35.67) and water intake (MD = 113.33; CI95:40.42,186.25), than controls. At 5y they consumed less non-core drinks (MD = -27.60; CI95:-54.58,-0.62). Sweet snack intake was lower for intervention children at both 3.6y (MD = -5.70; CI95:-9.75,-1.65) and 5y (MD = -6.84; CI95:-12.47,-1.21). Intervention group children viewed approximately 10 min/day less television than controls at both follow-ups, although the confidence intervals spanned zero (MD = -9.63; CI95:-30.79,11.53; MD = -11.34; CI95:-25.02,2.34, respectively). There was no evidence for effect on zBMI, waist circumference z-score or physical activity. Conclusions: The impact of this low-dose intervention delivered during infancy was still evident up to school commencement age for several targeted health behaviors but not adiposity. Some of these effects were only observed after the conclusion of the intervention, demonstrating the importance of long-term follow-up of interventions delivered during early childhood. Trial registration: ISRCTN Register ISRCTN81847050, registered 7th November 2007. [ABSTRACT FROM AUTHOR]

Background: This study demonstrates how formative process evaluation was used to assess implementation and improve dose and fidelity in the Together Everyone Achieves More Physical Activity (TEAM-PA) randomized controlled trial. TEAM-PA uses a randomized group cohort design to evaluate the efficacy of a group-based intervention for increasing physical activity among African American women. Methods: Intervention groups met for 10 weeks and were co-led by female African American facilitators, with intervention sessions consisting of group feedback, a health curriculum, group-based physical activity games, and group-based goal-setting. Drawing from a multi-theoretical framework, the intervention targeted social affiliation using collaborative and competitive group strategies, including essential elements focused on group-based behavioral skills, peer-to-peer positive communication, collectivism, optimal challenge, social facilitation, and peer to peer challenges. Formative process evaluation was used to monitor reach, dose, and fidelity, and implement feedback and solutions. Results: Across two cohorts, four groups (n = 54) were randomized to the TEAM-PA intervention. On average 84.8% of participants attended each week, which exceeded the a priori criteria. Results from the systematic observations indicated that on average 93% of the dose items were completed in each session and adequate levels of fidelity were achieved at both the facilitator and group-levels. Participants were compliant with wearing the FitBits (6.73 ± 0.42 days/week) and most participants successfully contributed to meeting the group-based goals. The use of open-ended items also revealed the need for additional modifications to the group-based PA games, including allowing for individuals to take breaks, incorporating a broader range of exercises, minimizing activities that required bending/reaching down without assistance, and providing facilitators with additional training for implementing the games. Initial evidence suggests that these changes were successful in increasing participants' comprehension of the games from Cohort 1 (M = 1.83, SD = 0.71) to Cohort 2 (M = 3.33, SD = 0.69). Conclusion: Findings from this study demonstrated high levels of reach, dose, and fidelity, while also highlighting strategies for implementing competitive group-based PA games that are accessible across physical fitness levels. Formative process evaluation, including open-ended items and collaborative brainstorming, holds tremendous potential for improving future interventions. Trial registration: This study was registered on Clinicaltrials.gov (# NCT05519696) on August 22, 2022 prior to the enrollment of the first participant on September 12, 2022 (https://clinicaltrials.gov/study/NCT05519696?term=NCT05519696&rank=1). [ABSTRACT FROM AUTHOR]

Background: Affective responses are increasingly recognized as potentially effective intervention targets that may facilitate exercise and physical activity behavior change. While emerging correlational evidence suggests that more pleasant affective responses are associated with higher participation and adherence, experimental evidence remains scarce. In light of this, we conducted a preregistered, pragmatic, single-blinded, superiority randomized controlled trial with two parallel groups, with the goal of determining the impact of an individualized exercise-intensity prescription targeting pleasure on exercise frequency. Methods: Forty-seven non-regular exercisers were randomized into two groups. For both groups, the intervention consisted of three exercise sessions based on the Frequency-Intensity-Time-Type (FITT) principle. However, the experimental group also received an individualized intensity prescription based on prior assessment of preference for and tolerance of exercise intensity, as well as instructions emphasizing the promotion of pleasure as a basis for self-regulating exercise intensity. The primary outcome was gymnasium attendance over an eight-week follow-up period. Secondary outcomes were affective valence and arousal, post-exercise enjoyment, core affective exercise experiences, and anticipated and remembered affect. Results: Forty-six participants were retained for analysis (Mage = 32.00; SD = 8.62 years; 56.5% female). Compared to the control group, the experimental group exhibited 77% higher session attendance (14.35 vs. 8.13 sessions) over the eight-week follow-up period (group main effect p =.018, η2p =.120; Cohen's d ranged from 0.28 to 0.91 during follow-up). Also, the experimental group reported higher levels of pleasure during the intervention sessions (for all group main effects, p <.001, η2p from.33 to.37) and higher levels of remembered pleasure (group main effect p =.021, η2p =.116) and anticipated pleasure (group main effect p =.022, η2p =.114). No harm was detected. Conclusions: These results demonstrate the practicality and effectiveness of an intervention aimed at enhancing affective responses to exercise in improving short-term session attendance. Trial registration: ClinicalTrial.gov NCT05416593. [ABSTRACT FROM AUTHOR]

Background According to the CONSORT statement, significance testing of baseline differences in randomized controlled trials should not be performed. In fact, this practice has been discouraged by numerous authors throughout the last forty years. During that time span, reporting of baseline differences has substantially decreased in the leading general medical journals. Our own experience in the field of nutrition behavior research however, is that coauthors, reviewers and even editors are still very persistent in their demand for these tests. The aim of this paper is therefore to negate this demand by providing clear evidence as to why testing for baseline differences between intervention groups statistically is superfluous and why such results should not be published. Discussion Testing for baseline differences is often propagated because of the belief that it shows whether randomization was successful and it identifies real or important differences between treatment arms that should be accounted for in the statistical analyses. Especially the latter argument is flawed, because it ignores the fact that the prognostic strength of a variable is also important when the interest is in adjustment for confounding. In addition, including prognostic variables as covariates can increase the precision of the effect estimate. This means that choosing covariates based on significance tests for baseline differences might lead to omissions of important covariates and, less importantly, to inclusion of irrelevant covariates in the analysis. We used data from four supermarket trials on the effects of pricing strategies on fruit and vegetables purchases, to show that results from fully adjusted analyses sometimes do appreciably differ from results from analyses adjusted for significant baseline differences only. We propose to adjust for known or anticipated important prognostic variables. These could or should be pre-specified in trial protocols. Subsequently, authors should report results from the fully adjusted as well as crude analyses, especially for dichotomous and time to event data. Summary Based on our arguments, which were illustrated by our findings, we propose that journals in and outside the field of nutrition behavior actively adopt the CONSORT 2010 statement on this topic by not publishing significance tests for baseline differences anymore. [ABSTRACT FROM AUTHOR]

Background: Interactive web-based physical activity interventions using Web 2.0 features (e.g., social networking) have the potential to improve engagement and effectiveness compared to static Web 1.0 interventions. However, older adults may engage with Web 2.0 interventions differently than younger adults. The aims of this study were to determine whether an interaction between intervention (Web 2.0 and Web 1.0) and age group (<55y and ≥55y) exists for website usage and to determine whether an interaction between intervention (Web 2.0, Web 1.0 and logbook) and age group (<55y and ≥55y) exists for intervention effectiveness (changes in physical activity). Methods: As part of the WALK 2.0 trial, 504 Australian adults were randomly assigned to receive either a paper logbook (n = 171), a Web 1.0 (n = 165) or a Web 2.0 (n = 168) physical activity intervention. Moderate to vigorous physical activity was measured using ActiGraph monitors at baseline 3, 12 and 18 months. Website usage statistics including time on site, number of log-ins and number of step entries were also recorded. Generalised linear and intention-to-treat linear mixed models were used to test interactions between intervention and age groups (<55y and ≥55y) for website usage and moderate to vigorous physical activity changes. Results: Time on site was higher for the Web 2.0 compared to the Web 1.0 intervention from baseline to 3 months, and this difference was significantly greater in the older group (OR = 1.47, 95%CI = 1.01-2.14, p = .047). Participants in the Web 2.0 group increased their activity more than the logbook group at 3 months, and this difference was significantly greater in the older group (moderate to vigorous physical activity adjusted mean difference = 13.74, 95%CI = 1.08-26.40 min per day, p = .03). No intervention by age interactions were observed for Web 1.0 and logbook groups. Conclusions: Results partially support the use of Web 2.0 features to improve adults over 55 s' engagement in and behaviour changes from web-based physical activity interventions. [ABSTRACT FROM AUTHOR]

Background: The Healthy Lifestyles Programme (HeLP) was a novel school-located intervention for 9-10 year olds, designed to prevent obesity by changing patterns of child behaviour through the creation of supportive school and home environments using dynamic and creative delivery methods. This paper reports on both the quantitative and qualitative data regarding the implementation of the HeLP intervention in the definitive cluster randomised controlled trial, which was part of the wider process evaluation. Methods: Mixed methods were used to collect data on intervention uptake, fidelity of delivery in terms of content and quality of delivery of the intervention, as well as school and child engagement with the programme. Data were collected using registers of attendance, observations and checklists, field notes, focus groups with children and semi-structured interviews with teachers. Qualitative data were analysed thematically and quantitative data were summarized using descriptive statistics. Results: All 16 intervention schools received a complete or near complete programme (94-100%), which was delivered in the spirit in which it had been designed. Of the 676 children in the intervention schools, over 90% of children participated in each phase of HeLP; 92% of children across the socio-economic spectrum were deemed to be engaged with HeLP and qualitative data revealed a high level of enjoyment by all children, particularly to the interactive drama workshops. Further evidence of child engagment with the programme was demonstrated by children's clear understanding of programme messages around marketing, moderation and food labelling. Thirteen of the intervention schools were deemed to be fully engaged with HeLP and qualitative data revealed a high level of teacher 'buy in', due to the programme's compatability with the National Curriculum, level of teacher support and use of innovative and creative delivery methods by external drama practitioners. Conclusion: Our trial shows that it is possible to successfully scale up complex school-based interventions, engage schools and children across the socio-economic spectrum and deliver an intervention as designed. As programme integrity was maintained throughout the HeLP trial, across all intervention schools, we can be confident that the trial findings are a true reflection of the effectiveness of the intervention, enabling policy recommendations to be made. Trial registration: ISRCTN15811706. [ABSTRACT FROM AUTHOR]

Background: The retail market for toddler-specific packaged foods is growing. Many of these products are ultra-processed and high in nutrients of concern for health, yet marketed in ways that may make them appear wholesome. This study aims to assess parents' responses to claims on unhealthy, ultra-processed toddler food products and test whether removing such claims promotes more accurate product perceptions and healthier product preferences. Methods: Parents of toddlers aged 12 to < 36 months (N = 838) were recruited for an online experiment testing four on-pack claim conditions: control (no claim); 'contains "good" ingredient'; 'free from "bad" ingredient'; and unregulated 'child-related' claim. Participants were randomly assigned to one condition, then viewed images of toddler food products that varied in nutrition content and the claims displayed. Participants completed tasks assessing product preferences (unhealthy product displaying claim vs. a healthier option with no claim, across four food categories (banana bars, strawberry snacks, blueberry yogurt snacks and veggie snacks)), purchase intentions and product perceptions. Poisson regression (count variable) and linear regression (continuous outcomes) analyses were employed to test for mean differences by marketing claim conditions. Results: For the overall sample, brief exposure to 'free from "bad" ingredient' claims increased participant's intentions to purchase unhealthy food products for their toddlers, but there was no clear evidence that 'contains "good" ingredient' claims and 'child-related' claims significantly impacted parent's preferences, purchase intentions and perceptions of toddler foods. However, certain claims influenced particular parent subgroups. Notably, parents with three or more children chose more unhealthy products when these products displayed 'contains "good" ingredient' or 'free from "bad" ingredient' claims; the latter claims also promoted stronger purchase intentions and enhanced product perceptions among this subgroup. Conclusions: Findings indicate that 'free from "bad" ingredient' claims on unhealthy toddler foods are of most concern, as they boost the appeal of these products to parents. 'Contains "good" ingredient' claims and 'child-related' claims showed limited effects in this study. Considering available evidence, we recommend claims should not be permitted on child-oriented foods, as they may promote inaccurate product perceptions and unhealthy product choices by parents, that can detract from their children's diets and health. [ABSTRACT FROM AUTHOR]

Background: High consumption of sugar-sweetened beverages (SSB) is a global health concern. Additionally, sugar-sweetened beverage (SSB) consumption is disproportionately high among adolescents and adults in rural Appalachia. The primary study objective is to determine the intervention effects of Kids SIPsmartER on students' SSB consumption. Secondary objectives focus on caregivers' SSB consumption and secondary student and caregiver outcomes [e.g, body mass index (BMI), quality of life (QOL)]. Methods: This Type 1 hybrid, cluster randomized controlled trial includes 12 Appalachian middle schools (6 randomized to Kids SIPsmartER and 6 to control). Kids SIPsmartER is a 6-month, 12 lesson, multi-level, school-based, behavior and health literacy program aimed at reducing SSB among 7th grade middle school students. The program also incorporates a two-way text message strategy for caregivers. In this primary prevention intervention, all 7th grade students and their caregivers from participating schools were eligible to participate, regardless of baseline SSB consumption. Validated instruments were used to assess SSB behaviors and QOL. Height and weight were objectively measured in students and self-reported by caregivers. Analyses included modified two-part models with time fixed effects that controlled for relevant demographics and included school cluster robust standard errors. Results: Of the 526 students and 220 caregivers, mean (SD) ages were 12.7 (0.5) and 40.6 (6.7) years, respectively. Students were 55% female. Caregivers were mostly female (95%) and White (93%); 25% had a high school education or less and 33% had an annual household income less than $50,000. Regardless of SSB intake at baseline and relative to control participants, SSB significantly decreased among students [-7.2 ounces/day (95% CI = -10.7, -3.7); p < 0.001, effect size (ES) = 0.35] and caregivers [-6.3 ounces/day (95% CI = -11.3, -1.3); p = 0.014, ES = 0.33]. Among students (42%) and caregivers (28%) who consumed > 24 SSB ounces/day at baseline (i.e., high consumers), the ES increased to 0.45 and 0.95, respectively. There were no significant effects for student or caregiver QOL indicators or objectively measured student BMI; however, caregiver self-reported BMI significantly decreased in the intervention versus control schools (p = 0.001). Conclusions: Kids SIPsmartER was effective at reducing SSB consumption among students and their caregivers in the rural, medically underserved Appalachian region. Importantly, SSB effects were even stronger among students and caregivers who were high consumers at baseline. Trial registration: Clincialtrials.gov: NCT03740113. Registered 14 November 2018– Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03740113. [ABSTRACT FROM AUTHOR]

Background: Increased understanding of why and how physical activity impacts on health outcomes is needed to increase the effectiveness of physical activity interventions. A recent randomized controlled trial of an active video game (PlayStation EyeToy™) intervention showed a statistically significant treatment effect on the primary outcome, change from baseline in body mass index (BMI), which favored the intervention group at 24 weeks. In this short paper we evaluate the mediating effects of the secondary outcomes. Objective: To identify mediators of the effect of an active video games intervention on body composition. Methods: Data from a two-arm parallel randomized controlled trial of an active video game intervention (n = 322) were analyzed. The primary outcome was change from baseline in BMI. A priori secondary outcomes were considered as potential mediators of the intervention on BMI, including aerobic fitness (VO2Max), time spent in moderate-to-vigorous physical activity (MVPA), and food snacking at 24 weeks. Results: Only aerobic fitness at 24 weeks met the conditions for mediation, and was a significant mediator of BMI. Conclusion: Playing active video games can have a positive effect on body composition in overweight or obese children and this effect is most likely mediated through improved aerobic fitness. Future trials should examine other potential mediators related to this type of intervention. Trial registration: Australian New Zealand Clinical Trials Registry Website: http://www.anzctr.org.au Study ID number: ACTRN12607000632493 [ABSTRACT FROM AUTHOR]

Background: Home environment has an important influence on children's fruit and vegetable (FV) consumption, but children may in turn also impact their home FV environment, e.g. by asking for FV. The Squire's Quest II serious game intervention aimed to increase asking behaviors to improve home FV availability and children's FV intake. This study's aims were to assess: 1) did asking behaviors at baseline predict home FV availability at baseline (T0) (RQ1); 2) were asking behaviors and home FV availability influenced by the intervention (RQ2); 3) did increases in asking behaviors predict increased home FV availability (RQ3); and 4) did increases in asking behaviors and increases in home FV availability mediate increases in FV intake among children (RQ4)? Methods: This is a secondary analysis of a study using a randomized controlled trial, with 4 groups (each n = 100 child--parent dyads). All groups were analyzed together for this paper since groups did not vary on components relevant to our analysis. All children and parents (n = 400 dyads) received a self-regulation serious game intervention and parent material. The intervention ran for three months. Measurements were taken at baseline, immediately after intervention and at 3-month follow-up. Asking behavior and home FV availability were measured using questionnaires; child FV intake was measured using 24-h dietary recalls. ANCOVA methods (research question 1), linear mixed-effect models (research question 2), and Structural Equation Modeling (research questions 3 and 4) were used. Results: Baseline child asking behaviors predicted baseline home FV availability. The intervention increased child asking behaviors and home FV availability. Increases in child asking behaviors, however, did not predict increased home FV availability. Increased child asking behaviors and home FV availability also did not mediate the increases in child FV intake. Conclusions: Children influence their home FV environment through their asking behaviors, which can be enhanced via a serious game intervention. The obtained increases in asking behavior were, however, insufficient to affect home FV availability or intake. Other factors, such as child preferences, sample characteristics, intervention duration and parental direct involvement may play a role and warrant examination in future research. Trials Registration: ClinicalTrials.gov NCT01004094. Date registered 10/28/2009 [ABSTRACT FROM AUTHOR]

Background: Changing diet and physical activity behaviour is one of the cornerstones of type 2 diabetes treatment, but changing behaviour is challenging. The objective of this study was to identify behaviour change techniques (BCTs) and intervention features of dietary and physical activity interventions for patients with type 2 diabetes that are associated with changes in HbA1c and body weight. Methods: We performed a systematic review of papers published between 1975-2015 describing randomised controlled trials (RCTs) that focused exclusively on both diet and physical activity. The constituent BCTs, intervention features and methodological rigour of these interventions were evaluated. Changes in HbA1c and body weight were meta-analysed and examined in relation to use of BCTs. Results: Thirteen RCTs were identified. Meta-analyses revealed reductions in HbA1c at 3, 6, 12 and 24 months of -1. 11 % (12 mmol/mol), -0.67 % (7 mmol/mol), -0.28 % (3 mmol/mol) and -0.26 % (2 mmol/mol) with an overall reduction of -0.53 % (6 mmol/mol [95 % CI -0.74 to -0.32, < 0.00001]) in intervention groups compared to control P groups. Meta-analyses also showed a reduction in body weight of -2.7 kg, -3.64 kg, -3.77 kg and -3.18 kg at 3, 6, 12 and 24 months, overall reduction was -3.73 kg (95 % CI -6.09 to -1.37 kg, = 0.002). P Four of 46 BCTs identified were associated with >0.3 % reduction in HbA1c: 'instruction on how to perform a behaviour', 'behavioural practice/rehearsal', 'demonstration of the behaviour' and 'action planning', as were intervention features 'supervised physical activity', 'group sessions', 'contact with an exercise physiologist', 'contact with an exercise physiologist and a dietitian', 'baseline HbA1c >8 %' and interventions of greater frequency and intensity. Conclusions: Diet and physical activity interventions achieved clinically significant reductions in HbA1c at three and six months, but not at 12 and 24 months. Specific BCTs and intervention features identified may inform more effective structured lifestyle intervention treatment strategies for type 2 diabetes. [ABSTRACT FROM AUTHOR]

Background: Most adolescent girls fail to meet current physical activity guidelines. Physical activity behaviours track from childhood into adulthood and providing adolescent girls with opportunities to be physically active may have health benefits beyond childhood. The effects of walking interventions on adult cardiometabolic health are known, however less is understood about the potential of walking to promote physical activity in adolescents. Following the Walking In ScHools (WISH) feasibility study, this definitive trial aimed to evaluate the effectiveness of a novel, low-cost, school-based walking intervention at increasing physical activity levels of adolescent girls (aged 12–14 years). Methods: Female pupils were recruited from eighteen schools across the border region of Ireland and in Northern Ireland. In intervention schools (n = 9), girls aged 15–18 years, were trained as walk leaders, and led the younger pupils in 10–15 min walks before school, at break and lunch recess. All walks took place in school grounds and pupils were encouraged to participate in as many walks as possible each week. The primary outcome measure was accelerometer determined total physical activity (counts per minutes, cpm). Results: In total, 589 pupils were recruited to the study. At baseline, pupils engaged in a median (interquartile range (IQR)) 35.7 (21.2) mins moderate-vigorous physical activity (MVPA) per day and only 12% (n = 66) of participants met physical activity guidelines (60 min MVPA per day). The intervention was delivered for a mean (standard deviation (SD)) 19.9 ± 0.97 weeks. The mean post-intervention total physical activity for the intervention group was 676 cpm and 710 cpm in the control group. Post-intervention total physical activity did not statistically differ between groups when adjusted for age, body mass index z-scores and baseline physical activity (mean difference, -33.5, 95% CI = -21.2 to 88.1; p = 0.213). Conclusions: 'Scaling-up' physical activity interventions is challenging and despite a promising feasibility study, the results of this fully powered trial suggest that in this context, the WISH intervention did not increase device measured physical activity. Since the COVID-19 pandemic, school environments have changed and although pupils enjoyed the programme, attendance at walks was low, indicating that there is a need to better understand how to implement interventions within schools. Trial registration: ISRCTN; ISRCTN12847782; Registered 2nd July 2019. [ABSTRACT FROM AUTHOR]

Background: Few school-based interventions have been successful in reducing physical activity decline and preventing overweight and obesity in adolescent populations. As a result, few cost effectiveness analyses have been reported. The aim of this paper is to report the cost and cost effectiveness of the Physical Activity 4 Everyone (PA4E1) intervention which was a multi-component intervention implemented in secondary schools located in low-income communities. Cost effectiveness was assessed using both the physical activity and weight status trial outcomes. Methods: Intervention and Study Design: The PA4E1 cluster randomised controlled trial was implemented in 10 Australian secondary schools (5 intervention: 5 control) and consisted of intervention schools receiving seven physical activity promotion strategies and six additional strategies that supported school implementation of the intervention components. Costs associated with physical activity strategies, and intervention implementation strategies within the five intervention schools were estimated and compared to the costs of usual physical activity practices of schools in the control group. The total cost of implementing the intervention was estimated from a societal perspective, based on the number of enrolled students in the target grade at the start of the intervention (Grade 7, n = 837). Economic Outcomes: The economic analysis outcomes were cost and incremental cost effectiveness ratios for the following: minutes of moderate-to-vigorous physical activity (MVPA) per day gained, MET hours gained per person/day; Body Mass Index (BMI) unit avoided; and 10 % reduction in BMI z-score. Results: The intervention cost AUD $329,952 over 24 months, or AUD$394 per student in the intervention group. This resulted in a cost effectiveness ratio of AUD$56 ($35-$147) per additional minute of MVPA, AUD$1 ($0.6-$2.7) per MET hour gained per person per day, AUD$1408 ($788-$6,570) per BMI unit avoided, and AUD$563 ($282-$3,942) per 10 % reduction in BMI z-score. Conclusion: PA4E1 is a cost effective intervention for increasing the physical activity levels and reducing unhealthy weight gain in adolescence, a period in which physical activity typically declines. Additional modelling could explore the potential economic impact of the intervention on morbidity and mortality. [ABSTRACT FROM AUTHOR]

Background: TXT2BFiT was one of the first few innovative mHealth programs designed for young adults (18-35 years) with demonstrated efficacy in weight management. However, research is lacking to understand intervention effectiveness, especially in complex, multi-component mHealth programs. This paper investigates participant perceptions of and engagement with the mHealth program components in the TXT2BFiT to understand program effects. Methods: Process evaluation data were collected continuously for the study duration. The TXT2BFiT program was a multi-component lifestyle program delivered intensively for 3-month followed by a 6-month maintenance phase. Program components included personalised coaching calls, text messages, emails, smartphone apps and website access. Process evaluation measures included frequency of use of components and frequency for number of components used (online survey data); dose delivered and engagement with program components (researcher logs and web platform reports); frequency, timing and difficulties experienced with program components (online survey data) and overall perceptions of program components (online survey data and semi-structured telephone interviews). Qualitative data analysis was performed using NVivo10. Results: Over 80 % of participants completed post-intervention (3-months, intervention, n = 110, control n = 104) and follow-up surveys (9-months, intervention, n = 96, control n = 104). Thirty intervention participants completed semi-structured telephone interviews. Participants reported high use of coaching calls, text messages and emails and no issues in content delivery from these components. These components were described as helping them to achieve their goals. Website and app use and engagement was low for the duration of the program. Participants would prefer incorporation of the self-monitoring apps and website resources into one smartphone application that can be individualised by entry of their personal data. Conclusions: Our process evaluation has allowed a comprehensive understanding of use and preference for different program components. The high value placed on the coaching calls is consistent with a desire for personalisation of the mHealth program and even further tailoring of text messages and emails. The findings of this study will be used to revise TXT2BFiT for future users. Trial registration: The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12612000924853). [ABSTRACT FROM AUTHOR]

Background: Physical inactivity is high in Latinas, as are chronic health conditions. There is a need for physical activity (PA) interventions that are not only effective but have potential for cost-effective widespread dissemination. The purpose of this paper was to assess the costs and cost effectiveness of a Spanish-language print-based mail- delivered PA intervention that was linguistically and culturally adapted for Latinas. Methods: Adult Latinas (N = 266) were randomly assigned to receive mail-delivered individually tailored intervention materials or wellness information mailed on the same schedule (control). PA was assessed at baseline, six months (post-intervention) and 12 months (maintenance phase) using the 7-Day Physical Activity Recall Interview. Costs were calculated from a payer perspective, and included personnel time (wage, fringe, and overhead), materials, equipment, software, and postage costs. Results: At six months, the PA intervention cost $29/person/month, compared to $15/person/month for wellness control. These costs fell to $17 and $9 at 12 months, respectively. Intervention participants increased their PA by an average of 72 min/week at six months and 94 min/week at 12 months, while wellness control participants increased their PA by an average of 30 min/week and 40 min/week, respectively. At six months, each minute increase in PA cost $0.18 in the intervention group compared to $0.23 in wellness control, which fell to $0.07 and $0.08 at 12 months, respectively. The incremental cost per increase in physical activity associated with the intervention was $0.15 at 6 months and $0.05 at 12 months. Conclusions: While the intervention was more costly than the wellness control, costs per minute of increase in PA were lower in the intervention. The print-based mail-delivered format has potential for broad, cost-effective dissemination, which could help address disparities in this at-risk population. Trial registration: NCT01583140; Date of Registration: 03/06/2012; Funding Source of Trial: National Institute of Nursing Research (NINR); Name of Institutional Review Board: Brown University IRB; Date of Approval: 05/19/2009. [ABSTRACT FROM AUTHOR]

Background: Effective, low-cost approaches are needed to enhance dietary behavior change. While both video and tailoring technology have been effective interventions to improve diet, these approaches have never been combined to study the effectiveness of tailored videos. The purpose of this paper is to discuss the results of Good For You!, a randomized trial that tested the efficacy of innovative, individually tailored videos in helping worksite employees decrease dietary fat and increase fruit and vegetable (F&V) intake. Methods: Worksites were matched on approximate size, type of company and workforce composition and randomized to one of three experimental conditions: Non-Tailored written information (NT) (n = 14), Tailored Written information (TW) (n = 14), or Tailored Written + Tailored Video (TW + TV) (n =15). Evaluation was conducted at baseline, 4 and 7 months. We used the NCI Fat Screener and an adapted Food Habits Questionnaire (FHQ) to estimate fat intake and fat-related behaviors, the NCI F&V Screener and F&V Habits Questionnaire (FVHQ) to measure F&V intake and behaviors. Generalized linear models were examined for all outcome measurements. Results: 2525 worksite employees were recruited. At 4 months, dietary fat intake decreased significantly more for TW (-2.95 %) and TW + TV (-3.14 %) compared with NT (-2.42 %). FHQ scores decreased significantly more for TW + TV than the other two groups. Fruit intake increased the most for TW + TV compared to NT and TW. Both TW (1.30 cups) and TW + TV (1.59 cups) increased F&V intake significantly more than NT (0.78 cups). TW + TV showed the largest increase in F&V behaviors on the FVFQ. At 8 months, dietary fat change continued to be significantly better for TW + TV (-3.48 %) than NT (3.01 %). F&V intake increased significantly more for the TW + TV group (1.38 cups) compared to the NT group (1.04 cups) and FVHQ changes were significantly greater in TW + TV and TW than for NT. Conclusions: The tailored intervention participants were more likely to decrease fat and increase F&V intake. The TW + TV group was generally the stronger of the two tailored interventions, especially at the longer term follow-up, demonstrating the promise of tailored video as an intervention to change eating habits. Future studies should explore newer channels and technologies in addition to DVDs for delivering tailored video interventions such as the internet and smart phones. [ABSTRACT FROM AUTHOR]

Background: Involvement in meal preparation and eating meals with one’s family are associated with better dietary quality and healthy body weight for youth. Given the poor dietary quality of many youth, potential benefits of family meals for better nutritional intake and great variation in family meals, development and evaluation of interventions aimed at improving and increasing family meals are needed. This paper presents the design of key intervention components and process evaluation of a community-based program (Healthy Home Offerings via the Mealtime Environment (HOME) Plus) to prevent obesity. Methods: The HOME Plus intervention was part of a two-arm (intervention versus attention-only control) randomized-controlled trial. Ten monthly, two-hour sessions and five motivational/goal-setting telephone calls to promote healthy eating and increasing family meals were delivered in community-based settings in the Minneapolis/ St. Paul, MN metropolitan area. The present study included 81 families (8-12 year old children and their parents) in the intervention condition. Process surveys were administered at the end of each intervention session and at a home visit after the intervention period. Chi-squares and t-tests were used for process survey analysis. Results: The HOME Plus program was successfully implemented and families were highly satisfied. Parents and children reported that the most enjoyable component was cooking with their families, learning how to eat more healthfully, and trying new recipes/foods and cooking tips. Average session attendance across the ten months was high for families (68%) and more than half completed their home activities. Conclusions: Findings support the value of a community-based, family-focused intervention program to promote family meals, limit screen time, and prevent obesity. Trial registration: NCT01538615 [ABSTRACT FROM AUTHOR]

Background. The implementation of a complex intervention is heavily influenced by individual context. Variation in implementation and tailoring of the intervention to the particular context will occur, even in a trial setting. It is recognised that in trials, evaluating the process of implementation of a complex intervention is important, yet process evaluation methods are rarely reported. The WAVES study is a cluster randomised controlled trial to evaluate the effectiveness of an obesity prevention intervention programme targeting children aged 6–7 years, delivered by teachers in primary schools across the West Midlands, UK. The intervention promoted activities encouraging physical activity and healthy eating. This paper presents the methods used to assess implementation of the intervention. Methods. Previous literature was used to identify the dimensions of intervention process and implementation to be assessed, including adherence, exposure, quality of delivery, participant responsiveness, context, and programme differentiation. Results. Multiple methods and tools were developed to capture information on all these dimensions. These included observations, logbooks, qualitative evaluation, questionnaires and research team reflection. Discussion. Data collection posed several challenges, predominantly when relying on teachers to complete paperwork, which they saw as burdensome on top of their teaching responsibilities. However, the use of multiple methods helped to ensure data on each dimension, where possible, was collected using more than one method. This also allowed for triangulation of the findings when several data sources on any one dimension were available. Conclusions. We have reported a comprehensive approach to the assessment of the implementation and processes of a complex childhood obesity prevention intervention within a cluster randomised controlled trial. These approaches can be transferred and adapted for use in other complex intervention trials. [ABSTRACT FROM AUTHOR]

Background: Active travel and school settings are considered ideal for promoting physical activity. However, previous research suggests limited effect of school-based interventions on overall physical activity levels among adolescents. The relationship between physical activity in different domains remains inconclusive. In this study, we examined the effects of adding two weekly hours of school-based physical activity on active travel rates. Method: We analyzed data from 1370 pupils in the 9th-grade participating in the cluster RCT; the School In Motion (ScIM) project. Intervention schools (n = 19) implemented 120 min of class-scheduled physical activity and physical education, in addition to the normal 2 hours of weekly physical education in the control schools (n = 9), for 9 months. Active travel was defined as pupils who reported walking or cycling to school, while motorized travel was defined as pupils who commuted by bus or car, during the spring/summer half of the year (April–September), or autumn/winter (October–February). The participants were categorized based on their travel mode from pretest to posttest as; maintained active or motorized travel ("No change"), changing to active travel (motorized-active), or changing to motorized travel (active-motorized). Multilevel logistic regression was used to analyze the intervention effect on travel mode. Results: During the intervention period, most participants maintained their travel habits. In total, 91% of pupils maintained their travel mode to school. Only 6% of pupils switched to motorized travel and 3% switched to active travel, with small variations according to season and trip direction. The intervention did not seem to influence the likelihood of changing travel mode. The odds ratios for changing travel habits in spring/summer season were from active to motorized travel 1.19 [95%CI: 0.53–2.15] and changing from motorized to active travel 1.18 [0.30–2.62], compared to the "No change" group. These findings were consistent to and from school, and for the autumn/winter season. Conclusion: The extra school-based physical activity does not seem to affect rates of active travel among adolescents in the ScIM project. Trial registration: Clinicaltrials.gov ID nr: NCT03817047. Registered 01/25/2019′ retrospectively registered'. [ABSTRACT FROM AUTHOR]

Background: The use of health technologies and gamification to promote physical activity has increasingly been examined, representing an opportunistic method for harnessing social support inherent within existing social ties. However, these prior studies have yielded mixed findings and lacked long-term follow-up periods. Thus, a pilot cluster randomized controlled trial was conducted to gauge the feasibility and preliminary efficacy of a digital gamification-based physical activity promotion approach among teams of insufficiently active adults with existing social ties. Methods: Teams (N = 24; 116 total participants) were randomized to either a 12-week intervention (Fitbit, step goals, app, feedback; TECH) or the same program plus gamification (TECH + Gamification). Mixed effects models were used to compare group differences in treatment adherence, and changes in social support, steps, and moderate-to-vigorous physical activity at 12 weeks and 52 weeks from baseline, adjusted for sociodemographic characteristics and team size. Results: TECH had a lower mean number of days of Fitbit self-monitoring versus TECH + Gamification during the intervention (adjusted difference: -.30; 95% CI, -.54 to -.07; P =.01). Post-intervention, TECH had 47% lower odds of self-monitoring 7 days per week versus TECH + Gamification (.53; 95% CI,.31 to.89; P =.02). No differences were observed between TECH + Gamification and TECH in increases in social support (0.04; 95% CI, -.21 to.29; P =.76), ActiGraph-measured daily steps (-425; 95% CI, -1065 to 215; P =.19), or moderate-to-vigorous physical activity minutes (-3.36; 95% CI, -8.62 to 1.91; P =.21) from baseline to 12 weeks or in the regression of these improvements by 1 year (Ps >.05). Although not significant in the adjusted models (Ps >.05), clinically meaningful differences in Fitbit-measured daily steps (TECH, 7041 ± 2520; TECH + Gamification, 7988 ± 2707) and active minutes (TECH, 29.90 ± 29.76; TECH + Gamification, 36.38 ± 29.83) were found during the intervention. Conclusions: A gamified physical activity intervention targeting teams of adults with existing social ties was feasible and facilitated favorable, clinically meaningful additive physical activity effects while in place but did not drive enhanced, long-term physical activity participation. Future investigations should explore optimal team dynamics and more direct ways of leveraging social support (training teams; gamifying social support). Trial registration: Clinicaltrials.gov (NCT03509129, April 26, 2018). [ABSTRACT FROM AUTHOR]

Background: Despite important implications for the budgets, statistical power and generalisability of research findings, detailed reports of recruitment and retention in randomised controlled trials (RCTs) are rare. The NOURISH RCT evaluated a community-based intervention for first-time mothers that promoted protective infant feeding practices as a primary prevention strategy for childhood obesity. The aim of this paper is to provide a detailed description and evaluation of the recruitment and retention strategies used. Methods: A two stage recruitment process designed to provide a consecutive sampling framework was used. Firsttime mothers delivering healthy term infants were initially approached in postnatal wards of the major maternity services in two Australian cities for consent to later contact (Stage 1). When infants were approximately four months old mothers were re-contacted by mail for enrolment (Stage 2), baseline measurements (Time 1) and subsequent random allocation to the intervention or control condition. Outcomes were assessed at infant ages 14 months (Time 2) and 24 months (Time 3). Results: At Stage 1, 86% of eligible mothers were approached and of these women, 76% consented to later contact. At Stage 2, 3% had become ineligible and 76% could be recontacted. Of the latter, 44% consented to full enrolment and were allocated. This represented 21% of mothers screened as eligible at Stage 1. Retention at Time 3 was 78%. Mothers who did not consent or discontinued the study were younger and less likely to have a university education. Conclusions: The consent and retention rates of our sample of first time mothers are comparable with or better than other similar studies. The recruitment strategy used allowed for detailed information from non-consenters to be collected; thus selection bias could be estimated. Recommendations for future studies include being able to contact participants via mobile phone (particularly text messaging), offering home visits to reduce participant burden and considering the use of financial incentives to support participant retention. [ABSTRACT FROM AUTHOR]

Background: A poor understanding of the specific lifestyle behaviors that result in weight loss has hindered the development of effective interventions. The aim of this paper was to identify potential behavioral mediators of weight loss in the Healthy Dads, Healthy Kids (HDHK) intervention for overweight fathers. Findings: The three-month intervention was evaluated in a randomized controlled trial and conducted in Newcastle, New South Wales, Australia. Baseline, three month (immediate post-intervention) and six month assessments were conducted. Recruitment and follow-up occurred between October 2008 and May 2009. The study sample included 53 overweight/obese men [mean (± SD) age = 40.6(± 97.1) years; body mass index (BMI) = 33.2 (±3.9) kgm-2] and their primary school-aged children [n = 71, 54% boys; age = 8.2 (±2.0) years] who were randomized to HDHK program or a wait-list control group. Physical activity (PA) was assessed using pedometers and dietary behaviors were measured using a validated food frequency questionnaire. The intervention resulted in significant weight loss (−5.13 ± 1.27 kg, P<0.0001) and increased PA among fathers (2769 ± 750 steps/day, P<0.001) and their children (1486 ± 521 steps/day, P<0.01). Fathers’ PA mediated weight loss in the intervention (AB = −2.31, 95% CI = −4.63 to −0.67) and was responsible for 47% of the intervention effect. Changes in dietary behaviors were not statistically significant. Conclusions: PA was an important mediator of weight loss in the HDHK intervention. Encouraging overweight fathers to be more active with their children appears to be a promising strategy for obesity treatment in men. [ABSTRACT FROM AUTHOR]

Background: Attempts to demonstrate the efficacy of interventions aimed at increasing physical activity (PA) have been mixed. Further, studies are seldom designed in a manner that facilitates the understanding of how or why a treatment is effective or ineffective and PA intervention designs should be guided by a heavier reliance upon behavioral theory. The use of a mediating variable framework offers a systematic methodological approach to testing the role of theory, and could also identify the effectiveness of specific intervention components. The primary purpose of this paper was to test the mediating role that cognitive constructs may have played in regards to the positive effect that a workplace behavioral intervention had on leisure-time PA for women. A subsidiary purpose was to examine the cross-sectional relationships of these cognitive constructs with PA behavior. Methods: The Physical Activity Workplace Study was a randomized controlled trial which compared the effects of stage-matched and standard print materials upon self-reported leisure-time PA, within a workplace sample at 6 and 12-months. In this secondary analysis we examined the mediation effects of 14 psychosocial constructs across 3 major social-cognitive theories which were operationalized for the intervention materials and measured at baseline, 6 and 12-months. We examined change in PA and change in the psychological constructs employing a mediation strategy proposed by Baron and Kenny for: (1) the first 6-months (i.e., initial change), (2) the second 6-months (i.e., delayed change), and (3) the entire 12-months (overall change) of the study on 323 women (n = 213 control/standard materials group; n = 110 stage-matched materials group). Results: Of the 14 constructs and 42 tests (including initial, delayed and overall change) two positive results were identified (i.e., overall change in pros, initial change in experiential powerful intervention approaches processes), with very small effect sizes. However, these mediating results were eliminated after adjusting for the multiple statistical tests. Conclusions: The intervention did not change these mediators in any substantive way, and show a similar pattern to prior research where interventions generally do not result in a change in mediation of behavior change. It is important to report mediation results in randomized controlled trials whether the findings are null or positive. Future studies may wish to focus on more detailed dose-response issues between mediators and behavior, the inclusion of moderators that could affect individual change, or different mediator constructs at higher levels of measurement specificity. Continued work on innovative and more powerful PA intervention approaches are needed. [ABSTRACT FROM AUTHOR]

Background: Reducing portion sizes of commercially available foods could be an effective public health strategy to reduce population energy intake, but recent research suggests that the effect portion size has on energy intake may differ based on socioeconomic position (SEP). Objective: We tested whether the effect of reducing food portion sizes on daily energy intake differed based on SEP. Methods: Participants were served either smaller or larger portions of food at lunch and evening meals (N = 50; Study 1) and breakfast, lunch and evening meals (N = 46; Study 2) in the laboratory on two separate days, in repeated-measures designs. The primary outcome was total daily energy intake (kcal). Participant recruitment was stratified by primary indicators of SEP; highest educational qualification (Study 1) and subjective social status (Study 2), and randomisation to the order portion sizes were served was stratified by SEP. Secondary indicators of SEP in both studies included household income, self-reported childhood financial hardship and a measure accounting for total years in education. Results: In both studies, smaller (vs larger) meal portions led to a reduction in daily energy intake (ps <.02). Smaller portions resulted in a reduction of 235 kcal per day (95% CI: 134, 336) in Study 1 and 143 kcal per day (95% CI: 24, 263) in Study 2. There was no evidence in either study that effects of portion size on energy intake differed by SEP. Results were consistent when examining effects on portion-manipulated meal (as opposed to daily) energy intake. Conclusions: Reducing meal portion sizes could be an effective way to reduce overall daily energy intake and contrary to other suggestions it may be a socioeconomically equitable approach to improving diet. Trial registration: These trials were registered at www.clinicaltrials.gov as NCT05173376 and NCT05399836. [ABSTRACT FROM AUTHOR]

Background: Policy interventions to increase physical activity in early childhood education and care (ECEC) services are effective in increasing physical activity among young children. However, a large proportion of ECEC services do not have nor implement a physical activity policy. Play Active is an evidence-informed physical activity policy intervention with implementation support strategies to enable ECEC services to successfully implement their policy. This study examined the effectiveness, implementation, and process outcomes of Play Active. Methods: A pragmatic cluster randomised trial in 81 ECEC services in Perth, Western Australia was conducted in 2021. Services implemented their physical activity policy over a minimum of three months. The effectiveness outcomes were changes in educator practices related to daily time provided for total physical activity and energetic play. Implementation outcomes included changes in director- and educator-reported uptake of policy practices and director-reported uptake of high impact and low effort policy practices. Process evaluation outcomes included awareness, fidelity, reach, and acceptability of the intervention and implementation strategies. Analysis involved descriptive statistics and generalised linear mixed effects models. Results: There was a significant increase in the uptake of director-reported policy practices (p = 0.034), but no change in the uptake of the subset of high impact and low effort policy practices. Intervention group educators reported high awareness of the Play Active policy recommendations (90%). Play Active acceptability was high among educators (83%) and directors (78%). Fidelity and reach were high for most implementation support strategies (> 75%). There were no significant changes in the amount of physical activity or energetic play educators provided to children or in the proportion of educators providing the policy recommended ≥ 180 min of physical activity/day or ≥ 30 min of energetic play/day for intervention compared to wait-listed comparison services. Conclusions: Play Active resulted in significantly higher uptake of physical activity practices. However, there was no change in the amount of physical activity provided to children, which may be explained by the relatively short policy implementation period. Importantly, Play Active had high awareness, fidelity, reach, and acceptability. Future research should investigate the effectiveness of Play Active over longer implementation periods and its scalability potential. Trial registration: Australian New Zealand Clinical Trials Registry (reference number 12620001206910, registered 13/11/2020, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378304&isReview=true). [ABSTRACT FROM AUTHOR]

Background: Depressive symptoms result in considerable burden for breast cancer survivors. Increased physical activity may reduce these burdens but existing evidence from physical activity interventions in equivocal. Furthermore, physical activity intervention strategies may differentially impact depressive symptoms, which should be considered in designing and optimizing behavioral interventions for breast cancer survivors. Methods: The Physical Activity for Cancer Survivors (PACES) trial enrolled 336 participants breast cancer survivors, who were 3 months to 10 years post-treatment, and insufficiently active (< 150 min of moderate-to-vigorous physical activity per week). Participants were randomly assigned to a combination of 4 intervention strategies in a full-factorial design: 1) supervised exercise sessions, 2) facility access, 3) Active Living Every Day, and 4) Fitbit self-monitoring. Depressive symptoms were assessed at baseline, mid-intervention (3 months), and post-intervention (6 months) using the Quick Inventory for Depressive Symptoms. Change in depressive symptoms were analyzed using a linear mixed-effects model. Results: Results from the linear mixed-effects model indicated that depressive symptoms decreased significantly across the entire study sample over the 6-month intervention (F = 4.09, p = 0.044). A significant ALED x time interaction indicated participants who received the ALED intervention experienced greater reductions in depressive symptoms (F = 5.29, p = 0.022). No other intervention strategy significantly impacted depressive symptoms. Conclusions: The ALED intervention consists of strategies (i.e., goal setting, social support) that may have a beneficial impact on depressive symptoms above and beyond the effect of increased physical activity. Our findings highlight the need to consider secondary outcomes when designing and optimizing physical activity interventions. Trial registration: ClinicalTrials.gov NCT03060941. Posted February 23, 2017. [ABSTRACT FROM AUTHOR]

Background: Childhood overweight and obesity is a public health priority. We have previously reported the efficacy of a parent-oriented mobile health (mHealth) app-based intervention (MINISTOP 1.0) which showed improvements in healthy lifestyle behaviors. However, the effectiveness of the MINISTOP app in real-world conditions needs to be established. Objective: To evaluate the real-world effectiveness of a 6-month mHealth intervention (MINISTOP 2.0 app) on children's intake of fruits, vegetables, sweet and savory treats, sweet drinks, moderate-to-vigorous physical activity, and screen time (primary outcomes), and on parental self-efficacy (PSE) for promoting healthy lifestyle behaviors, and children's body mass index (BMI) (secondary outcomes). Methods: A hybrid type 1 effectiveness-implementation design was utilized. For the effectiveness outcomes, a two-arm, individually randomized controlled trial was conducted. Parents (n = 552) of 2.5-to-3-year-old children were recruited from 19 child health care centers across Sweden, and, randomized to either a control (standard care) or intervention group (MINISTOP 2.0 app). The 2.0 version was adapted and translated into English, Somali and Arabic to increase reach. All recruitment and data collection were conducted by the nurses. Outcomes were assessed at baseline and after six months, using standardized measures (BMI) and a questionnaire (health behaviors, PSE). Results: Among the participating parents (n = 552, age: 34.1 ± 5.0 years), 79% were mothers and 62% had a university degree. Twenty-four percent (n = 132) of children had two foreign-born parents. At follow-up, parents in the intervention group reported lower intakes of sweet and savory treats (-6.97 g/day; p = 0.001), sweet drinks (-31.52 g/day; p < 0.001), and screen time (-7.00 min/day; p = 0.012) in their children compared to the control group. The intervention group reported higher total PSE (0.91; p = 0.006), PSE for promoting healthy diet (0.34; p = 0.008) and PSE for promoting physical activity behaviors (0.31; p = 0.009) compared to controls. No statistically significant effect was observed for children's BMI z-score. Overall, parents reported high satisfaction with the app, and 54% reported using the app at least once a week. Conclusion: Children in the intervention group had lower intakes of sweet and savory treats, sweet drinks, less screen time (primary outcomes) and their parents reported higher PSE for promoting healthy lifestyle behaviors. Our results from this real-world effectiveness trial support the implementation of the MINISTOP 2.0 app within Swedish child health care. Trial registration: Clinicaltrials.gov NCT04147039; https://clinicaltrials.gov/ct2/show/NCT04147039 [ABSTRACT FROM AUTHOR]

Background: The epidemic of non-communicable diseases (NCDs) is a growing concern worldwide and Singapore is no exception to this global trend. As part of measures to address this concern, the Singapore government will implement a mandatory color-coded front-of-package (FOP) nutrition label for beverages, called Nutri-Grade (NG), which will complement the existing FOP label, Healthier Choice Symbol (HCS) logos, currently displayed on select food and beverage items. NG grades beverages on a four-point scale, A (healthiest) to D (least healthy), in terms of sugar and saturated fat levels. This study aimed to evaluate the effectiveness of the NG label on nutritional quality of pre-packaged beverages using a fully functional online grocery store. Methods: We conducted a 2-arm crossover trial involving actual purchases with 138 participants randomly exposed to: 1) Control with HCS logos displayed on qualifying items; 2) Similar to Control except that all beverages displayed the NG label. The effects of the NG label were estimated using a linear mixed-effects model that addresses correlations between repeated measures and accommodates missing data. Results: We found that the NG label encouraged consumers to choose beverages with higher ratings. This led to a reduction in sugar from beverages purchased by 1.51 g [95% CI: − 2.68, − 0.34] per serving but was not effective at reducing saturated fat purchased (− 0.009 g [95% CI: − 0.22, 0.20]) per serving or improvements in overall diet quality, measured by the weighted (by the number of servings) average Nutri-Score value ranging from 1 to 5 (− 0.024 [95% CI: − 0.13, 0.08]). Conclusions: Results suggest that the Nutri-Grade label is likely to reduce sugar purchased from beverages. However, to improve overall diet quality in Singapore, additional measures will be needed. Trial registration: This trial was registered on ClinicalTrials.gov under the identifier: NCT05018026 on 24th August 2021. [ABSTRACT FROM AUTHOR]

Background: This study reports the outcomes of Communities for Healthy Living (CHL), a cluster randomized obesity prevention trial implemented in partnership with Head Start, a federally-funded preschool program for low-income families. Methods: Using a stepped wedge design, Head Start programs (n = 16; Boston, MA, USA) were randomly assigned to one of three intervention start times. CHL involved a media campaign and enhanced nutrition support. Parents were invited to join Parents Connect for Healthy Living (PConnect), a 10-week wellness program. At the beginning and end of each school year (2017-2019), data were collected on the primary outcome of child Body Mass Index z-score (BMIz) and modified BMIz, and secondary outcomes of child weight-related behaviors (diet, physical activity, sleep, media use) and parents' weight-related parenting practices and empowerment. Data from 2 years, rather than three, were utilized to evaluate CHL due to the COVID-19 pandemic. We used mixed effects linear regression to compare relative differences during intervention vs. control periods (n = 1274 vs. 2476 children) in (1) mean change in child BMIz and modified BMIz, (2) the odds of meeting child health behavior recommendations, (3) mean change in parenting practices, and (4) mean change in parent empowerment. We also compared outcomes among parents who chose post-randomization to participate in PConnect vs. not (n = 55 vs. 443). Results: During intervention periods (vs. control), children experienced greater increases in BMIz and modified BMIz (b = 0.06, 95% CI = 0.02,0.10; b = 0.07, 95% CI = 0.03, 0.12), yet were more likely to meet recommendations related to three of eight measured behaviors: sugar-sweetened beverage consumption (i.e., rarely consume; Odds Ratio (OR) = 1.5, 95% CI = 1.2,2.3), water consumption (i.e., multiple times per day; OR = 1.6, 95% CI = 1.2,2.3), and screen time (i.e., ≤1 hour/day; OR = 1.4, 95% CI = 1.0,1.8). No statistically significant differences for intervention (vs. control) periods were observed in parent empowerment or parenting practices. However, parents who enrolled in PConnect (vs. not) demonstrated greater increases in empowerment (b = 0.17, 95% CI = 0.04,0.31). Conclusions: Interventions that emphasize parent engagement may increase parental empowerment. Intervention exposure was associated with statistically, but not clinically, significant increases in BMIz and increased odds of meeting recommendations for three child behaviors; premature trial suspension may explain mixed results. Trial registration: ClinicalTrials.gov, NCT03334669, Registered October 2017. [ABSTRACT FROM AUTHOR]

Background: Partnering with a public transport (PT) provider, state government, and local government, the single-blinded randomised controlled trial, trips4health, investigated the impact of PT use incentives on transport-related physical activity (PA) in Tasmania, Australia. The intervention involved 16-weeks of incentives (bus trip credits) for achieving weekly PT use targets, supported by weekly text messages. This study objective was to conduct a process evaluation of the COVID-19 disrupted trips4health study. Methods: The Medical Research Council UK's framework for complex public health interventions guided the process evaluation. Participant reach, acceptability, fidelity and feasibility were evaluated. Administrative and post-intervention survey data were analysed descriptively. Semi-structured interviews with intervention participants (n = 7) and PT provider staff (n = 4) were analysed thematically. Results: Due to COVID-19, trips4health was placed on hold (March 2020) then stopped (May 2020) as social restrictions impacted PT use. At study cessation, 116 participants (approximately one third of target sample) had completed baseline measures, 110 were randomised, and 64 (n = 29 in the intervention group; n = 35 in the control group) completed post-intervention measures. Participants were 18 – 80 years (average 44.5 years) with females (69%) and those with tertiary education (55%) over-represented. The intervention was delivered with high fidelity with 96% of bus trip credits and 99% of behavioural text messages sent as intended. Interviewed PT staff said implementation was highly feasible. Intervention participant acceptability was high with 90% reporting bus trip incentives were helpful and 59% reporting the incentives motivated them to use PT more. From a total of 666 possible bus trip targets, 56% were met with 38% of intervention participants agreeing and 41% disagreeing that 'Meeting the bus trip targets was easy'. Interviews and open-ended survey responses from intervention participants revealed incentives motivated bus use but social (e.g., household member commitments) and systemic (e.g., bus availability) factors made meeting bus trip targets challenging. Conclusions: trips4health demonstrated good acceptability and strong fidelity and feasibility. Future intervention studies incentivising PT use will need to ensure a broader demographic is reached and include more supports to meet PT targets. Trial registration: ACTRN12619001136190. [ABSTRACT FROM AUTHOR]

Background: Physical activity (PA) is known to be beneficial for health, but adherence to international PA guidelines is low across different subpopulations. Interventions have been designed to stimulate PA of different target groups by influencing relevant psycho-social determinants, essentially based on a combination of the Integrated Model for Change, the Theory of Planned Behaviour, its successor the Reasoned Action Approach and the self-determination theory. The current study investigates the pathways through which interventions influence PA. Further, gender differences in pathways of change are studied. Methods: An integrated dataset of five different randomised controlled trial intervention studies is analysed by estimating a Bayesian network. The data include measurements, at baseline and at 3, 6 (short-term), and 12 (long-term) months after the baseline, of important socio-cognitive determinants of PA, demographic factors, and PA outcomes. A fragment is extracted from the Bayesian network consisting of paths between the intervention variable, determinants, and short- and long-term PA outcomes. For each relationship between variables, a stability indicator and its mutual information are computed. Such a model is estimated for the full dataset, and in addition such a model is estimated based only on male and female participants' data to investigate gender differences. Results: The general model (for the full dataset) shows complex paths, indicating that the intervention affects short-term PA via the direct determinants of intention and habit and that self-efficacy, attitude, intrinsic motivation, social influence concepts, planning and commitment have an indirect influence. The model also shows how effects are maintained in the long-term and that previous PA behaviour, intention and attitude pros are direct determinants of long-term PA. The gender-specific models show similarities as well as important differences between the structures of paths for the male- and female subpopulations. For both subpopulations, intention and habit play an important role for short-term effects and maintenance of effects in the long-term. Differences are found in the role of self-efficacy in paths of behaviour change and in the fact that attitude is relevant for males, whereas planning plays a crucial role for females. The average of these differences in subpopulation mechanisms appears to be presented in the general model. Conclusions: While previous research provided limited insight into how interventions influence PA through relevant determinants, the Bayesian network analyses show the relevance of determinants mentioned by the theoretical framework. The model clarifies the role that different determinants play, especially in interaction with each other. The Bayesian network provides new knowledge about the complex working mechanism of interventions to change PA by giving an insightful overview of influencing paths. Furthermore, by presenting subpopulation-specific networks, the difference between the influence structure of males and females is illustrated. These new insights can be used to improve interventions in order to enhance their effects. To accomplish this, we have developed a new methodology based on a Bayesian network analysis which may be applicable in various other studies. [ABSTRACT FROM AUTHOR]

Background: Physical activity (PA), diet, and health-related quality of life (HRQOL) are related to maternal and infant health, but interventions to improve these outcomes are needed in diverse pregnant women with elevated weight. Methods: Health In Pregnancy and Postpartum (HIPP) was a randomized controlled trial. Women who were pregnant (N=219, 44% African American, 56% white) with overweight or obesity but otherwise healthy were randomized to a behavioral intervention grounded in Social Cognitive Theory (n=112) or to standard care (n=107). The intervention group received an in-depth counseling session, a private Facebook group, and 10 content-based counseling calls with accompanying behavioral podcasts followed by weekly or biweekly counseling calls until delivery. The standard care group received monthly mailings and 10 podcasts focused on healthy pregnancy. PA (SenseWear armband), diet (ASA24), and HRQOL (SF-12) measures were obtained from blinded assessors at baseline (<16 weeks) and late pregnancy (32 weeks). Mixed model repeated measures regression models tested treatment (Group x Time) and within-group effects. We hypothesized that intervention participants would have higher levels of PA, a better-quality diet, and higher HRQOL than standard care participants. Exploratory analyses examined whether changes in outcomes over time differed according to whether participants had recommended, excessive, or inadequate weight gain. Results: Treatment effects favored intervention participants for vegetable intake (d=0.40, p<0.05) and % whole grains (d=0.60, p<0.01). HRQOL mental component improved in both groups, but less in intervention than standard care participants (d=-0.33, p<0.05). Time effects demonstrated that total PA, steps/day, and HRQOL physical component declined significantly in both groups. Within-group effects showed that diet quality significantly improved in intervention participants. Moderate-intensity PA declined significantly in standard care participants, whereas light-intensity PA declined and sedentary behavior increased significantly in intervention participants. Finally, exploratory analyses showed that total PA and light PA increased whereas sedentary behavior decreased among those meeting guidelines for weight gain, with opposite patterns seen among those with excessive or inadequate weight gain. Conclusions: The intervention improved several dietary outcomes but had modest impacts on PA and HRQOL, underscoring the challenge of behavior change during pregnancy. Trial registration: This trial was registered in ClinicalTrials.gov on 10/09/2014. NCT02260518 [ABSTRACT FROM AUTHOR]

Background: Our understanding of the mechanisms through which physical activity might benefit lipoprotein metabolism is inadequate. Here we characterise the continuous associations between physical activity of different intensities, sedentary time, and a comprehensive lipoprotein particle profile. Methods: Our cohort included 762 fifth grade (mean [SD] age = 10.0 [0.3] y) Norwegian schoolchildren (49.6% girls) measured on two separate occasions across one school year. We used targeted proton nuclear magnetic resonance (1H NMR) spectroscopy to produce 57 lipoprotein measures from fasted blood serum samples. The children wore accelerometers for seven consecutive days to record time spent in light-, moderate-, and vigorous-intensity physical activity, and sedentary time. We used separate multivariable linear regression models to analyse associations between the device-measured activity variables—modelled both prospectively (baseline value) and as change scores (follow-up minus baseline value)—and each lipoprotein measure at follow-up. Results: Higher baseline levels of moderate-intensity and vigorous-intensity physical activity were associated with a favourable lipoprotein particle profile at follow-up. The strongest associations were with the larger subclasses of triglyceride-rich lipoproteins. Sedentary time was associated with an unfavourable lipoprotein particle profile, the pattern of associations being the inverse of those in the moderate-intensity and vigorous-intensity physical activity analyses. The associations with light-intensity physical activity were more modest; those of the change models were weak. Conclusion: We provide evidence of a prospective association between time spent active or sedentary and lipoprotein metabolism in schoolchildren. Change in activity levels across the school year is of limited influence in our young, healthy cohort. Trial registration: ClinicalTrials.gov, #NCT02132494. Registered 7th April 2014 [ABSTRACT FROM AUTHOR]

Background: Scalable interventions that improve the nutritional quality of foods in children's lunchboxes have considerable potential to improve child public health nutrition. This study assessed the potential efficacy, feasibility and acceptability of an m-health intervention, 'SWAP IT', to improve the energy and nutritional quality of foods packed in children's lunchboxes. Methods: The study employed a 2X2 factorial cluster randomized-controlled trial design. Twelve primary schools in New South Wales, Australia were randomly allocated to one of four groups: (i) no intervention;(ii) physical activity intervention only;(iii) lunchbox intervention only; or(iv) physical activity and lunchbox intervention combined. The two intervention strategies were evaluated separately. This paper focuses on the effects of the lunchbox intervention only. The lunchbox intervention comprised four strategies: 1) school nutrition guidelines; 2) lunchbox lessons; 3) information pushed to parents via a school-communication app and 4) parent resources addressing barriers to packing healthy lunchboxes. Outcome measures were taken at baseline and immediately post-intervention (10 weeks) and included measures of effectiveness (mean energy (kJ) packed in lunchboxes, total energy and percentage energy from recommended foods consistent with Australian Dietary Guidelines), feasibility (of delivering intervention to schools, parent app engagement and behaviour change) and acceptability to school staff and parents. Linear mixed models were used to assess intervention efficacy. Results: Of the 1915 lunchbox observations, at follow-up there was no significant differences between intervention and control group in mean energy of foods packed within lunchboxes (− 118.39 kJ, CI = -307.08, 70.30, p = 0.22). There was a significant increase favouring the intervention in the secondary outcome of mean lunchbox energy from recommended foods (79.21 kJ, CI = 1.99, 156.43, p = 0.04), and a non-significant increase in percentage of lunchbox energy from recommended foods in intervention schools (4.57%, CI = -0.52, 9.66, p = 0.08). The views of the messages pushed via the app ranged from 387 to 1550 views per week (mean views =1025 per week). A large proportion (71%) of parents reported awareness of the intervention, making healthier swaps in the lunchbox (55%), and pushed content was helpful (84%). Conclusion: The study is the first RCT to assess the potential of a multi-component m-health lunchbox intervention. The intervention was feasible, acceptable and potentially effective in improving the nutritional quality of foods packed within children's lunchboxes. Trial registration: Australian Clinical Trials Registry ACTRN: ACTRN12616001228471. [ABSTRACT FROM AUTHOR]

Background: Strategies to optimize early-life nutrition provide an important opportunity for primary prevention of childhood obesity. Interventions that can be efficiently scaled-up to the magnitude needed for sustainable childhood obesity prevention are needed. The objective of this study was to evaluate the effects of an eHealth intervention on parental feeding practices and infant eating behaviors. Methods: The Norwegian study Early Food for Future Health is a randomized controlled trial. Parents were recruited via social media and child health clinics during spring 2016 when their child was aged 3 to 5 months. In total 718 parents completed a web-based baseline questionnaire at child age 5.5 months. The intervention group had access to a webpage with monthly short video clips addressing specific infant feeding topics and age-appropriate baby food recipes from child age 6 to 12 months. The control group received routine care. The primary outcomes were child eating behaviors, dietary intake, mealtime routines and maternal feeding practices and feeding styles. The secondary outcomes were child anthropometry. This paper reports outcomes at child age 12 months. Results: More than 80% of the intervention group reported viewing all/most of the video clips addressing infant feeding topics and indicated that the films were well adapted to the child's age and easy to understand. Children in the intervention group were served vegetables/fruits more frequently (p = 0.035) and had tasted a wider variety of vegetables (p = 0.015) compared to controls. They were also more likely to eat family breakfast (p = 0.035) and dinner (p = 0.011) and less likely to be playing or watching TV/tablet during meals (p = 0.009) compared to control-group children. We found no group differences for child anthropometry or maternal feeding practices. Conclusions: Our findings suggest that the eHealth intervention is an appropriate and feasible tool to propagate information on healthy infant feeding to Norwegian mothers. Our study also suggests that anticipatory guidance on early protective feeding practices by such a tool may increase young children's daily vegetable/fruit intake and promote beneficial mealtime routines. Trial registration: ISRCTN, ISRCTN13601567. Registered 29 February 2016, http://www.isrctn.com/ISRCTN13601567 [ABSTRACT FROM AUTHOR]

Background: Understanding the motivational effects of supervised aerobic high-intensity interval training (HIIT) may help men with prostate cancer undergoing active surveillance initiate and maintain exercise behavior, however, few studies have addressed this question. This report explored exercise motivation in men with prostate cancer undergoing active surveillance participating in a randomized exercise trial. Methods: The Exercise during Active Surveillance for Prostate Cancer (ERASE) trial randomized 52 men with prostate cancer on active surveillance to the HIIT exercise group or the usual care (UC) group. The exercise program was supervised aerobic HIIT conducted three times per week for 12 weeks. The motivation questions were developed using the Theory of Planned Behavior and included motivational constructs, anticipated and experienced outcomes, and barriers to HIIT during active surveillance. Results: The HIIT group attended 96% of the planned exercise sessions with 100% compliance to the exercise protocol. Motivation outcome data were obtained in 25/26 (96%) participants in the HIIT group and 25/26 (96%) participants in the UC group. At baseline, study participants were generally motivated to perform HIIT. After the intervention, the HIIT group reported that HIIT was even more enjoyable (p < 0.001; d = 1.38), more motivating (p = 0.001; d = 0.89), more controllable (p < 0.001; d = 0.85), and instilled more confidence (p = 0.004; d = 0.66) than they had anticipated. Moreover, compared to UC, HIIT participants reported significantly higher perceived control (p = 0.006; d = 0.68) and a more specific plan (p = 0.032; d = 0.67) for performing HIIT over the next 6 months. No significant differences were found in anticipated versus experienced outcomes. Exercise barriers were minimal, however, the most often reported barriers included pain or soreness (56%), traveling to the fitness center (40%), and being too busy and having limited time (36%). Conclusion: Men with prostate cancer on active surveillance were largely motivated and expected significant benefits from a supervised HIIT program. Moreover, the men assigned to the HIIT program experienced few barriers and achieved high adherence, which further improved their motivation. Future research is needed to understand long-term exercise motivation and behavior change in this setting. Trial registration: Clinicaltrials.gov, NCT03203460. Registered on June 29, 2017. [ABSTRACT FROM AUTHOR]

Background: The e-coachER trial aimed to determine whether adding web-based behavioural support to exercise referral schemes (ERS) increased long-term device-measured physical activity (PA) for patients with chronic conditions, compared to ERS alone, within a randomised controlled trial. This study explores the mechanisms of action of the e-coachER intervention using measures of the behaviour change processes integral to the intervention's logic model. Methods: Four hundred fifty adults with obesity, diabetes, hypertension, osteoarthritis or history of depression referred to an ERS were recruited in Plymouth, Birmingham and Glasgow. The e-coachER intervention comprising 7-Steps to Health was aligned with Self-Determination Theory and mapped against evidence-based behaviour change techniques (BCTs). Participants completed questionnaires at 0, 4, and 12 months to assess PA and self-reported offline engagement with core BCTs in day-to-day life (including action planning and self-monitoring) and beliefs relating to PA (including perceived importance, confidence, competence, autonomy and support). We compared groups at 4 and 12 months, controlling for baseline measures and other covariates. Mediation analysis using the product of coefficients method was used to determine if changes in process variables mediated intervention effects on moderate to vigorous physical activity (MVPA) recorded by accelerometer and self-report at 4- and 12-months. Results: The internal reliability (Cronbach's alpha) for all multi-item scales was > 0.77. At 4-months, those randomised to e-coachER reported higher levels of PA beliefs relating to importance (1.01, 95% confidence interval (CI): 0.42 to 1.61, p = 0.001), confidence (1.28, 95% CI: 0.57 to 1.98, p < 0.001), competence (1.61, 95% CI:.68 to 2.54, p = 0.001), availability of support (0.77, 95% CI: 0.07 to 1.48, p = 0.031), use of action planning (1.54, 95% CI: 0.23 to 2.85, p = 0.021) and use of self-monitoring (0.76, 95% CI: 0.19 to 1.32, p = 0.009) compared to ERS alone. There were no intervention effects on autonomous beliefs or perceived frequency of support, compared to ERS alone. At the 12-month follow-up, participants belief in the importance of PA was the only process measure to remain significantly higher in the e-coachER group when compared to ERS alone (0.75, 95% CI: 0.05 to 1.45). Intervention effects on perceived importance (2.52, 95% CI: 0.45 to 5.39), action planning (1.56, 95% CI: 0.10 to 3.54) and self-monitoring (1.92, 95% CI: 0.21 to 4.33) at 4-months significantly mediated change in accelerometer measured MVPA at 12-months (recorded in ≥ 10-min bouts). Conclusions: e-coachER led to some short-term changes in most process outcomes. Some of these processes also appeared to mediate e-coachER effects on changes in accelerometer measured MVPA. Further work should be carried out to understand how best to design and implement theoretically underpinned web-based physical activity promotion interventions within ERS. Trial registration: ISRCTN, ISRCTN15644451. Registered 12 February 2015. [ABSTRACT FROM AUTHOR]

Background: High school canteens are an ideal setting for public health nutrition intervention, and choice architecture strategies that facilitate the purchase of healthier foods and beverages from school canteens are recommended by the World Health Organization. The rapid uptake of online lunch ordering within school canteens provides a unique opportunity to implement choice architecture strategies that support healthier food choices with high fidelity. Despite this, no trial has tested the efficacy of choice architecture strategies within an online lunch ordering system on improving the nutritional quality of high school student lunch purchases. The objective of this study was to assess the impact of embedding choice architecture strategies into an online lunch ordering system on the nutritional quality of the school canteen lunch purchases of high school students (aged 12–19 years). Methods: A cluster randomized controlled trial was conducted with nine high schools in one Australian state. Schools were randomized to receive either a 2-month choice architecture intervention (involving menu labelling, prompts, item positioning, and feedback), or usual online ordering. Nutrient quality of online canteen lunch purchases was assessed using routine data collected by the online ordering system. Primary outcomes were the proportion of 'Everyday', 'Occasional', and 'Should not be sold' items purchased, categorized using the state healthy canteen policy. Secondary outcomes were the mean energy, saturated fat, sugar, and sodium content of purchases and the mean weekly revenue from online lunch orders. Linear mixed models were analyzed to assess outcomes. Results: Analysis of the student cohort (Intervention: 4 schools, 656 students; Control: 5 schools, 675 students) showed significant between group differences over time for the intervention group for the mean percentage of online lunch items per student that were 'Everyday' (+ 5.5%; P < 0.001) and 'Should not be sold' (− 4.4%; P < 0.001). There were no between group differences over time in the mean percentage of online lunch items that were 'Occasional'; the average energy, saturated fat, sugar, or sodium content of lunch orders. There was also no difference in mean weekly revenue from high school student online lunch orders (P = 0.23). Conclusions: These findings suggest that a low intensity, choice architecture intervention embedded within an online ordering system can increase the purchase of healthier food items for high school students in one Australian state without any adverse impact on canteen revenue. Trial registration: This trial was prospectively registered on Open Science Framework on 23rd October 2020 as osf.io/h8zfr. [ABSTRACT FROM AUTHOR]

Background: Latina women are less likely to report engaging in leisure-time physical activity (PA) than non-Latina white women. This study evaluated the 24-month impact of a faith-based PA intervention targeting Latinas. Methods: The study is a cluster randomized controlled trial of a PA intervention or cancer screening comparison condition, with churches as the randomization unit. A total of 436 Latinas (aged 18-65 years) from 16 churches who engaged in low levels of self-report and accelerometer-based PA were enrolled. The experimental condition was a 24-month PA intervention, with in-person classes, social support, and environmental changes, led by community health workers (i.e., promotoras). At baseline, 12-, and 24 months, we assessed changes in accelerometer-based and self-reported moderate to vigorous physical activity (MVPA; primary outcomes). Secondary outcomes were light intensity activity, sedentary time, body mass index (BMI), and waist circumference. Results: After adjusting for sociodemographic factors, a mixed effects analysis found significant increases in self-reported leisure time MVPA (p < 0.005) and marginal increases in accelerometer-assessed MVPA (p < 0.08) 24 months post-baseline in the intervention compared to the attention-control condition. Data showed significant associations between PA class attendance and engaging in MVPA as assessed by self-report and accelerometry. No significant changes were found for light activity, sedentary time, BMI, or waist circumference. Conclusions: Participants who attended the PA classes at least once a month engaged in significantly higher MVPA compared to those who did not. Maximizing engagement and maintenance strategies to enhance PA maintenance could contribute to important long-term health benefits. Trial registration: NCT01776632, Registered March 18, 2011. [ABSTRACT FROM AUTHOR]

Background: It is unknown if and how children's movement behaviour accumulation patterns change as a result of physical activity and/or sedentary behaviour interventions. It is important to establish the effectiveness of interventions targeting changes in such accumulation patterns. This study aimed to investigate the effect of the Transform-Us! school- and home-based intervention program on children's movement behaviour accumulation patterns, focusing on sporadic accumulation versus time in bouts. Methods: Baseline and post-intervention (18 months) accelerometer data from the Transform-Us! 2 × 2 factorial design cluster randomised controlled trial was used (Melbourne, 2010–2012; analytical sample n = 267; aged 8–9 years). Linear mixed models were fitted to examine effects of three different interventions (targeting increases in physical activity [PA-I], reductions in sedentary time [SB-I], or both [PA + SB-I]) compared to a usual practice (control) group on post-intervention movement behaviour accumulation compositions with eight components, including sporadic time and bouts of sedentary time, and light-, moderate- and vigorous-intensity physical activity. Results: Intervention effects on distribution of time in the post-intervention waking movement behaviour accumulation composition (adjusted for baseline composition) were small and not significant. However, visual inspection of the change in compositions over time revealed that only groups with a sedentary behaviour intervention component (SB-I and PA + SB-I) reduced time in sedentary bouts, compared to the overall sample compositional mean. In addition, the SB-I group was the only group with an increase in vigorous-intensity physical activity. The combined intervention group (PA + SB-I) was characterized by the largest proportional increase in MPA bouts. The usual practice group was characterized by the largest proportional increases in both sporadic and bouts of sedentary time. Conclusions: This study showed some early evidence to suggest that the "break up your sitting" message may result in greater impact than the "move more" message. Future research, including larger sample sizes, should investigate if this type of messaging is indeed more effective in changing movement behaviours and ultimately child health. Trial registration: International Standard Randomized Controlled Trial Number ISRCTN83725066; Australian New Zealand Clinical Trials Registry Number ACTRN12609000715279. [ABSTRACT FROM AUTHOR]

Background: Older adults are the least active population in the U.S. Low-income communities have fewer physical activity (PA) resources, contributing to less PA and increased chronic disease risk. This study assessed the effect of the multilevel, peer-led, Peer Empowerment Program 4 Physical Activity (PEP4PA) on moderate-to-vigorous PA (MVPA) and health outcomes, over 2 years of follow up. Methods: In a cluster-randomized controlled trial, 12 senior or community centers serving low-income older adults were assigned to a PA intervention (n = 6) or usual programming (n = 6) condition. PEP4PA included self-monitoring, health coaching, group walks, social support, and community advocacy to improve walking conditions. The primary outcome was daily minutes of MVPA (7-day accelerometer). Secondary outcomes included Perceived Quality of Life (PQoL), 6-Minute Walk Test (6-MWT), blood pressure (BP), and depressive symptoms at baseline, 6, 12, 18 and 24 months. Mixed effects regression models estimated the effects on outcomes between groups over time and included random effects for repeated measures and center clustering. Effect modification by sex and income status was assessed. We calculated the incremental cost per daily minute of MVPA gained in the intervention group relative to the control group to assess cost effectiveness. Results: We enrolled 476 older adults (50 + years). Participants were on average 71 years old, 76% female, 60% low income, and 38% identified as racial or ethnic minorities. Compared to the control group, intervention participants sustained roughly a 10 min/day increase in MVPA from baseline at all time points and increased mean PQoL scores from unsatisfied at baseline to satisfied at 12, 18 and 24 months. Males and higher-income groups had greater improvements in MVPA. No significant effects were observed for 6-MWT or depressive symptoms, and BP results were mixed. The incremental cost per minute MVPA gained per person was $0.25, $0.09, $0.06, and $0.05 at 6, 12, 18 and 24 months, respectively. Conclusions: PEP4PA achieved increases in MVPA and PQoL in low-income older adults, over 2 years of follow up. The peer-led, community-based intervention provides a sustainable and cost-effective model to improve health behaviors in underserved, aging populations. Trial registration: ClinicalTrials.gov (NCT02405325) March 20, 2015. [ABSTRACT FROM AUTHOR]

Background: Firstborn children have higher rates of obesity compared to secondborns, perhaps due, in part, to differential feeding practices. Despite the centrality of siblings in family life and potential for influence, almost nothing is known about the role of siblings in parent feeding practices in early childhood. Methods: Participants (n = 117) were mothers of consecutively born siblings. Firstborns participated in an RCT that compared a responsive parenting intervention designed for primary prevention of obesity against a safety control. Secondborns participated in an observational cohort. Multilevel models tested whether and how firstborn characteristics (temperament, appetite, rapid weight gain) at 16 weeks and 1 year were associated maternal feeding practices of secondborns in infancy at 16 weeks, 28 weeks, and 1 year (food to soothe) and at ages 1, 2, and 3 years (structure-and control-based feeding practices). A purposive subsample (n = 30) of mothers also participated in semi-structured interviews to further illuminate potential sibling influences on maternal feeding practices during infancy and toddlerhood. Results: Firstborn characteristics did not predict secondborn feeding in infancy (all ps > 0.05). Firstborn negative affect, however, predicted mothers' less consistent mealtime routines (b (SE) = − 0.27 (0.09); p = 0.005) and more pressure (b (SE) = 0.38 (0.12); p = 0.001). Firstborn appetite predicted mothers' less frequent use of food to soothe (b (SE) = − 0.16 (0.07); p = 0.02) when secondborns were toddlers. Firstborn surgency, regulation, and rapid weight gain, however, did not predict secondborn feeding practices during toddlerhood (all ps > 0.05). Interviews with mothers revealed three ways that maternal experiences with firstborns informed feeding practices of secondborns: 1) Use of feeding practices with secondborn that worked for the firstborn; 2) Confidence came from firstborn feeding experiences making secondborn feeding less anxiety-provoking; and 3) Additional experiences with firstborn and other factors that contributed to secondborn feeding practices. Conclusions: Some firstborn characteristics and maternal experiences with firstborns as well as maternal psychosocial factors may have implications for mothers' feeding practices with secondborns. Together, these mixed methods findings may inform future research and family-based interventions focused on maternal feeding of siblings in early childhood. [ABSTRACT FROM AUTHOR]

Background: With a rapidly ageing society, healthy ageing has become a key challenge. Engagement in physical activity, and particularly walking, is a key strategy that contributes to healthy ageing amongst older adults. The purpose of the present study was to evaluate the efficacy of a group walking program for older adults that incorporates the 5R Shared Leadership Program (5RS). By implementing a structure of shared leadership and strengthening peer leaders' identity leadership, 5RS aims to cultivate a shared social identity amongst participants, which has in other contexts been associated with greater performance and well-being. Methods: A cluster randomised controlled trial was conducted to test the efficacy of the 5RS group walking program on group identification, group cohesion, walking activity, and well-being, compared to a regular group walking program for older adults. Nineteen older adult walking groups (i.e., the clusters; N = 503; Mage = 69.23 years, SD = 6.68) all participated in a 12-week structured group walking program. Nine walking groups (n = 304) were randomly assigned to the intervention in which participants received the 5RS program in addition to regular group walking. Results: 5RS was successful in strengthening the identity leadership qualities of the appointed peer leaders. Multilevel regressions showed that 5RS succeeded in increasing group cohesion and walking activity to a greater extent than a regular group walking program, while participants' group identification and well-being increased to a similar extent in both conditions. Furthermore, structural equation modelling revealed that group identification mediated the impact of peer leaders' identity leadership on group cohesion and well-being (but not walking activity). Conclusion: By harnessing the capacity of the group and its peer leaders, the 5RS program offers a promising intervention to engage older adults in physical activity. Trial registration: The study was retrospectively registered as clinical trial on 9 September 2021 (NCT05038423). [ABSTRACT FROM AUTHOR]

Background: Childcare settings are important environments for influencing child eating and physical activity (PA). Family childcare homes (FCCH) care for many children of low-income and diverse racial/ethnic backgrounds who are at greater risk for poor diet quality, low PA, and obesity, but few interventions have targeted this setting. The aim of this study was to assess the efficacy of a multicomponent intervention conducted in FCCH on the diet quality and PA of 2–5 year old children in their care. Trial design: Cluster randomized trial. Methods: The cluster-randomized trial, Healthy Start/Comienzos Sanos (2015–2019) evaluated an 8-month nutrition and PA intervention that included four components: (1) monthly telephone calls from a support coach using brief motivational interviewing, (2) tailored reports, newsletters and videos, (3) group support meetings, and (4) active play toys. After completing baseline measurement, FCCH were randomized into intervention or comparison groups in matched pairs. Both groups received the same intervention components but on different topics (intervention: nutrition/PA vs. comparison: reading readiness/literacy). Evaluation staff were blinded to group assignment. Child primary outcome measures collected at baseline and 8-months included: 1) Healthy Eating Index (HEI-2015) scores calculated from diet observation, and 2) accelerometer measurement of PA. Process measures were collected from field data and provider surveys. Generalized Estimating Equation Models assessed changes in HEI-2015 scores and PA over time by experimental condition. Results: Ethnically diverse FCCH providers (n = 119) and 2-to-5-year-old children in their care (n = 377) were included in the final analysis. Process evaluation showed high participation in all intervention components except for group meetings. Compared to children in comparison group FCCH, children in intervention FCCH increased total HEI-2015 scores by 7.2 points (p <.001) including improvement in component scores for vegetables (0.84 points, p =.025) and added sugar (0.94 points, p =.025). For PA, compared to children in the comparison group, children in intervention FCCH decreased sedentary time by 5.7% (p =.021). Conclusions: The multicomponent Healthy Start intervention was effective in improving diet quality and sedentary behavior of children in FCCH, which demonstrates the promise of obesity prevention interventions in this setting. Future research could include enhancing the Healthy Start intervention to strengthen the PA component, considering virtual peer support, and determining how to best translate and disseminate the intervention into FCCH nationally. Trial registration: National Institutes of Health, NCT02452645. Registered 5 May 2015. [ABSTRACT FROM AUTHOR]

Background: Fruit and vegetable (F&V) intake can reduce risks for chronic disease, but is much lower than recommended amounts in most Western populations, especially for those with low income levels. Rigorous research is needed on practical, cost-effective interventions that address environmental as well as personal determinants of F&V intake. This paper presents the results of a cluster randomized controlled trial evaluating the efficacy of ‘Live Well, Viva Bien’ (LWVB), a multicomponent intervention that included discount, mobile fresh F&V markets in conjunction with nutrition education. Methods: Fifteen subsidized housing sites in Providence County, Rhode Island (8 intervention and 7 control sites) were randomized using a random number generator. Of these, nine housed elderly and/or disabled residents and six housed families. A total of 1597 adult housing site residents (treatment n = 837; control n = 760) were enrolled (73% women, 54% Hispanic, 17% black, Mean age 54 years). A year-long multicomponent intervention including mobile F&V markets plus nutrition education (e.g. campaigns, DVDs, newsletters, recipes, and chef demonstrations) was implemented at intervention sites. Physical activity and stress interventions were implemented at control sites. Follow-up occurred at 6 and 12 months. The main outcome measure was F&V consumption measured by National Cancer Institute’s ‘Eating at America’s Table All Day Screener’. Results: From baseline to 12 months, the intervention group increased total F&V intake by 0.44 cups with the control group decreasing intake by 0.08 cups (p <.02). Results also showed an increased frequency of F&V eating behaviors compared to the control group (p <.01). There was a clear dose response effect of the F&V markets with participants who reported attending all or most of the markets increasing F&V intake by 2.1 cups and 0.86 cups, respectively compared with less than half cup increases for lower levels of market attendance (p <.05). Use of the DVDs, recipes and taste-testings was also associated with greater increases in F&V intake; however, use of other educational components was not. Conclusions: LWVB is the first cluster, randomized controlled trial to demonstrate the efficacy of year-round F&V markets on improving F&V intake for low-income adults, which provides an evidence-base to bolster the mission of mobile produce markets. Further, the results more broadly support investment in environmental changes to alleviate disparities in F&V consumption and diet-related health inequities. Trial registration number: Clinicatrials.gov registration number: NCT02669472 [ABSTRACT FROM AUTHOR]