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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: Self-management education programmes are cost-effective in helping people with type 2 diabetes manage their diabetes, but referral and attendance rates are low. This study reports on the effectiveness of the Embedding Package, a programme designed to increase type 2 diabetes self-management programme attendance in primary care. Methods: Using a cluster randomised design, 66 practices were randomised to: (1) a wait-list group that provided usual care for nine months before receiving the Embedding Package for nine months, or (2) an immediate group that received the Embedding Package for 18 months. 'Embedders' supported practices and self-management programme providers to embed programme referral into routine practice, and an online 'toolkit' contained embedding support resources. Patient-level HbA1c (primary outcome), programme referral and attendance data, and clinical data from 92,977 patients with type 2 diabetes were collected at baseline (months − 3–0), step one (months 1–9), step 2 (months 10–18), and 12 months post-intervention. An integrated ethnographic study including observations, interviews, and document analysis was conducted using interpretive thematic analysis and Normalisation Process Theory. Results: No significant difference was found in HbA1c between intervention and control conditions (adjusted mean difference [95% confidence interval]: -0.10 [-0.38, 0.18] mmol/mol; -0.01 [-0.03, 0.02] %). Statistically but not clinically significantly lower levels of HbA1c were found in people of ethnic minority groups compared with non-ethnic minority groups during the intervention condition (-0.64 [-1.08, -0.20] mmol/mol; -0.06% [-0.10, -0.02], p = 0.004), but not greater self-management programme attendance. Twelve months post-intervention data showed statistically but not clinically significantly lower HbA1c (-0.56 [95% confidence interval: -0.71, -0.42] mmol/mol; -0.05 [-0.06, -0.04] %; p < 0.001), and higher self-management programme attendance (adjusted odds ratio: 1.13; 95% confidence interval: 1.02, 1.25; p = 0.017) during intervention conditions. Themes identified through the ethnographic study included challenges for Embedders in making and sustaining contact with practices and providers, and around practices' interactions with the toolkit. Conclusions: Barriers to implementing the Embedding Package may have compromised its effectiveness. Statistically but not clinically significantly improved HbA1c among ethnic minority groups and in longer-term follow-up suggest that future research exploring methods of embedding diabetes self-management programmes into routine care is warranted. Trial registration: ISRCTN23474120, registered 05/04/2018. [ABSTRACT FROM AUTHOR]

Background: Evaluations of Intimate Partner Abuse training for general practitioners is limited. The Women's Evaluation of Abuse and Violence Care study trialled in Australia was a primary care intervention that included delivering the Health Relationships training, a program that educates practitioners on how to provide supportive counselling and assistance to women afraid of an intimate partner. We report on effectiveness of the Healthy Relationships training program within a cluster-randomised controlled trial. Methods: General practitioners filled out a baseline survey and surveys before and after training, including quantitative and open-text questions on barriers and enablers to supporting victim-survivors. The Physician Readiness to Manage Intimate Partner Violence Survey (PREMIS) tool, a validated measure, was included to assess practitioner knowledge, skills, confidence, and attitudes. General linear model repeated analysis of variance tested the difference between trial groups over time. Results: Fifty-two general practitioners completed the baseline demographic survey, with 65% (19 intervention, 18 comparison) completing both pre-and-post-training surveys. There were no between-group differences in baseline characteristics. Post-training, the intervention group had significantly higher average scores than the comparison on perceived preparation to address abuse (p =.000), perceived knowledge (p =.000), actual knowledge (p =.03), and greater awareness of practice-related issues (p =.000). There were no between-group differences in PREMIS opinion domain scores on workplace issues, self-efficacy and understanding of victims. Post-training, the qualitative data indicated that the intervention practitioners (n = 24) reported increased knowledge, awareness, and confidence, while time pressures and lack of referral options impeded addressing abuse. Conclusion: The Healthy Relationships Training program for general practitioners increased aspects of practitioner knowledge, skills, and confidence. However, more support is needed to change opinions and support victim-survivors sustainably. Trial registration: The WEAVE trial was registered on 21/01/2008 with the Australian New Zealand Clinical Trial Registry, number ACTRN12608000032358. [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: 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. 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: The objective of this study was to investigate the effect of a 4-year specialist-taught Physical Education (PE) program on physical activity (PA) among primary school children. Methods: A 4-year cluster randomised controlled trial was conducted in children (initially aged 8 years) from 29 primary schools (13 Intervention, 16 Control). Intervention students (N = 457) received 2 x 45 min PE lessons per week from specialist-trained PE teachers (68 lessons per year, 272 lessons over 4 years). Control group students (N = 396) received usual practice PE from generalist classroom teachers. PA during PE lessons was examined using the System for Observing Fitness Instruction Time (SOFIT). Pedometers (steps/day) were worn for 7 days each year, and accelerometers were worn concurrently in the final two years to assess moderate to vigorous (MVPA) and sedentary activity. Linear and generalized mixed models were used to determine differences in Intervention and Control student PA and the proportion of students meeting PA guidelines. Results: The intervention increased SOFIT-observed student MVPA during PE lessons by 6.5 mins (16.7 v 10.2, p< 0.001). Within intervention schools, participants increased their whole-day step counts (boys = 449 [CI,140 to 756]; girls = 424 [CI,222 to 626]) and minutes of MVPA (boys = 8.0 [CI,6.8 to 9.2]; girls = 3.5 [CI,1.7 to 5.4]) on PE days. However, compared to the Control group the Intervention did not: increase habitual steps/day or MVPA when averaged over 7 days; elicit greater improvements in these measures over time; or increase the odds of meeting step/day or MVPA recommendations. At age 11 years Intervention group boys were 20 mins less sedentary per day (380 [CI,369 to 391] vs 360 [CI,350 to 369]) and this effect was sustained at age 12 years. Conclusions: Well-designed specialist-taught PE can improve student PA during PE lessons. However for PE to be a significant contributor to improving habitual PA in pre-adolescent children, daily classes are likely to be required, and even this would need to be supplemented with a wider multicomponent strategy. Our finding of a reduction in sedentary time among Intervention boys warrants further investigation into the potential role PE could play in influencing sedentary behaviour. [ABSTRACT FROM AUTHOR]

Background. Extracurricular programmes could provide a mechanism to increase the physical activity (PA) of primary-school-aged children. The aim of this feasibility study was to examine whether the Action 3:30 intervention, which is delivered by teaching assistants, holds promise as a means of increasing the PA of Year 5 and 6 children. Methods. A cluster randomised feasibility trial was conducted in 20 primary schools. Ten schools received the Action 3:30 intervention and 10 schools were allocated to the control arm. The intervention was 40 one-hour sessions, delivered twice a week by teaching assistants. The proportion of participants recruited per school was calculated. Session delivery and session attendance was calculated for intervention schools. Weekday and after-school (3.30 to 8.30 pm) moderate to vigorous intensity physical (MVPA) was assessed by accelerometer at baseline (T0), during the last few weeks of the intervention (T1) and four months after the intervention had ended (T2). The costs of delivering the intervention were estimated. Results. Five intervention schools ran all 40 of the intended sessions. Of the remaining five, three ran 39, one ran 38 and one ran 29 sessions. Mean attendance was 53%. The adjusted difference in weekday MVPA at T1 was 4.3 minutes (95% CI −2.6 to 11.3). Sex-stratified analyses indicated that boys obtained 8.6 more minutes of weekday MVPA than the control group (95% CI 2.8 to 14.5) at T1 with no effect for girls (0.15 minutes, 95% CI −9.7 to 10.0). There was no evidence that participation in the programme increased MVPA once the club sessions ceased (T2). The indicative average cost of this intervention was £2,425 per school or £81 per participating child during its first year and £1,461 per school or £49 per participating child thereafter. Conclusions. The effect of the Action 3:30 interventions was comparable to previous physical activity interventions but further analysis indicated that there was a marked sex difference with a positive impact on boys and no evidence of an effect on girls. The Action 3:30 intervention holds considerable promise but more work is needed to enhance the effectiveness of the intervention, particularly for girls. [ABSTRACT FROM AUTHOR]

Background: Consumption of non-core foods in childhood is associated with excessive weight gain in childhood. Parents play a vital role in establishing healthy diet behaviours in young children. The aim of this study was to assess the effectiveness of a telephone-based intervention in reducing child consumption of non-core foods, and to examine parent and home food environment mediators of change in child consumption. Methods: The 'Healthy Habits' trial utilised a clustered randomised controlled design. Setting/participants: Parents were recruited from 30 preschools (N = 394 participants, mean age 35.2±5.6 years). Parents randomized to the intervention group received four telephone contacts and print materials. Parents allocated to the control condition receive generic print materials only. Non-core food consumption was assessed using a validated child dietary questionnaire at baseline, 2 and 6 months post recruitment in 2010. Results: The intervention was effective in reducing child consumption of non-core foods at 2 months (intention to treat analysis: z=-2.83, p<.01), however this effect was not maintained at 6 months. Structural equation modelling using 2 month data indicated that child access to non-core foods in the home and child feeding strategies mediated the effect of the intervention. Conclusion: The telephone-based intervention shows promise in improving short term dietary behaviour in preschool age children, however further development is needed to sustain the effect in the long-term. Trial registration: Australian Clinical Trials Registry: ACTRN12609000820202. [ABSTRACT FROM AUTHOR]

Background: In patients with advanced, incurable cancer, anticancer treatment may be used to alleviate cancer-related symptoms, but monitoring of them in daily practice is rarely done. We aim to test the effectiveness of a real-time symptom and syndrome assessment using the E-MOSAIC software installed in handheld computer generating a longitudinal monitoring sheet (LoMoS) provided to the oncologists in a phase III setting. Methods: In this prospective multicentre cluster randomized phase-III trial patients with any incurable solid tumor and having defined cancer related symptoms, who receive new outpatient chemotherapy in palliative intention (expected tumor-size response rate ≤20%) are eligible. Immediately before the weekly visit to oncologists, all patients complete with nurse assistance the E-MOSAIC Assessment: Edmonton Symptom Assessment Scale, ≤3 additional symptoms, estimated nutritional intake, body weight, Karnofsky and medications for pain and cachexia. Experienced oncologists will be randomized to receive the LoMoS or not. To minimize contamination, LoMoS are removed from the medical charts after visits. Primary endpoint is the difference in global quality of life (items 29 & 30 of EORTC-QlQ-C30) between baseline and last study visit at week 6, with a 10 point between-arm difference considered to be clinically relevant. 20 clusters (=oncologists) per treatment arm with 4-8 patients each are aimed for to achieve a significance level of 5% and a power of 80% in a mixed model approach. Selected co- variables are included in the model for adjustment. Secondary endpoints include patient-perceived patient-physician communication symptom burden over time, and oncologists' symptom management performance (predefined thresholds of symptoms compared to oncologists' pharmacological, diagnostic or counselling actions [structured chart review]). Discussion: This trial will contribute to the research question, whether structured, longitudinal monitoring of patients' multidimensional symptoms, indicators for symptom management, and clinical benefit outcomes can influence patients' quality of life and symptom distress, in a setting of routine oncology practice. Trial registration: Current Controlled Trials NCT00477919 [ABSTRACT FROM AUTHOR]

Background: Many adolescent girls do not engage in sufficient physical activity (PA). This study examined the feasibility of conducting a cluster randomized controlled trial (RCT) to evaluate an after-school dance program to increase PA among 11-12 year old girls in Bristol, UK. Methods: Three-arm, cluster RCT. Three secondary schools were assigned to intervention arm. Intervention participants received a 9-week dance program with 2, 90-minute dance classes per week. Participants at 2 control schools received incentives for data collection. Participants at 2 additional control schools received incentives and a delayed dance workshop. Accelerometer data were collected at baseline (time 0), during the last week of the dance program (time 1) and 20 weeks after the start of the study (time 2). Weekly attendance, enjoyment and perceived exertion were assessed in intervention participants. Post-study qualitative work was conducted with intervention participants and personnel. Results: 40.1% of girls provided consent to be in the study. The mean number of girls attending at least one dance session per week ranged from 15.4 to 25.9. There was greater number of participants for whom accelerometer data were collected in control arms. The mean attendance was 13.3 sessions (maximum = 18). Perceived exertion ratings indicated that the girls did not find the sessions challenging. The dance teachers reported that the program content would benefit from revisions including less creative task time, a broader range of dance genres and improved behavioral management policies. At time 2, the 95% confidence intervals suggest between 5 and 12 minutes more weekday MVPA in the intervention group compared with the control incentives only group, and between 6 minutes fewer and 1 minute more compared with the control incentives plus workshop group. Between 14 and 24 schools would be required to detect a difference of 10 minutes in mean weekday MVPA between intervention and control groups. Conclusions: It is possible to recruit 11-12 year old girls to participate in an after-school dance study. An after-school dance intervention has potential to positively affect the PA levels of 11-12 year old girls but an adequately powered RCT is required to test this intervention approach. [ABSTRACT FROM AUTHOR]

Background: There is limited knowledge as to whether obesity prevention interventions are able to produce change in the determinants hypothesized to precede change in energy balance-related behaviors in young people. The aim of this study was to evaluate the effect of a multi-component intervention on a wide range of theoretically informed determinants of physical activity (PA) and sedentary behavior (SB). Moderation effects of gender, weight status and parental education level and whether the perceived intervention dose received influenced the effects were also explored. Methods: The HEIA study was a 20-month school-based, randomized controlled trial to promote healthy weight development. In total, 1418 11-year-olds participated at baseline and post-intervention assessment. Enjoyment, self-efficacy, perceived social support from parents, teachers and friends related to PA, perceived parental regulation of TV-viewing and computer/game-use and perceived social inclusion at schools were examined by covariance analyses to assess overall effects and moderation by gender, weight status and parental education, mid-way and post-intervention. Covariance analyses were also used to examine the role of intervention dose received on change in the determinants. Results: At mid-way enjoyment (p = .03), perceived social support from teachers (p = .003) and self-efficacy (p = .05) were higher in the intervention group. Weight status moderated the effect on self-efficacy, with a positive effect observed among the normal weight only. At post-intervention results were sustained for social support from teachers (p = .001), while a negative effect was found for self-efficacy (p = .02). Weight status moderated the effect on enjoyment, with reduced enjoyment observed among the overweight. Moderation effects for parental education level were detected for perceived social support from parents and teachers. Finally, positive effects on several determinants were observed among those receiving a high as opposed to a low intervention dose. Conclusion: The intervention affected both psychological and social-environmental determinants. Results indicate that social support from teachers might be a potential mediator of PA change, and that overweight adolescents might be in need of specially targeted interventions to avoid reducing their enjoyment of PA. Further studies should continue to assess how intervention effectiveness is influenced by the participants’ self-reported dose of intervention received. [ABSTRACT FROM AUTHOR]