Search

Background: Identifying critical life transitions in people's physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited), and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group.Methods: This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum) with two assessment points at 6 weeks (3.5 months postpartum) and 3 months (5 months postpartum) and a final follow-up assessment at 6 months (8 months postpartum). The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity.Results: A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures.Discussion: If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform public health materials and practitioners.Trial Registration: This trial has been registered with the Clinical Trials Registry maintained by the National Library of Medicine at the National Institutes of Health on April 19, 2014. The registration ID is NCT02290808 . [ABSTRACT FROM AUTHOR]

Background: Common mental health problems, such as stress, anxiety and depression, are highly prevalent among workers and often lead to long-term absenteeism and work disability. Effective elements found in previous researched interventions were to explicitly focus on return to work (RTW) and not solely on symptom reduction, to take into account the employees' cognition towards RTW and to include the workplace environment. Based on these elements, a stepped-care approach was developed. The aim of this paper is to present the study design of a randomized controlled trial (RESTART), evaluating the effectiveness of the stepped-care approach on lasting RTW and the implementation process. Methods: RESTART is a randomized controlled trial with a 2 × 2 factorial design and a follow-up of one year. Employees eligible for this study are those who reported sick within 2 to 8 weeks with psychological distress based on a distress screener. Participants will be randomized to a group receiving a tailored e-Health app or usual care, as well as randomized to a group receiving a Participatory Approach (PA; conversational method) in the workplace or usual care. The PA will however only be provided in case of persistent sickness absence at 8 weeks. Measurements take place at baseline, after the e-Health intervention period (3 months), and after the PA intervention period (6 months) and 12 months. Primary outcome is lasting RTW, defined as full RTW in previous or equal work for at least four consecutive weeks. Secondary outcomes are (the severity of) stress-related symptoms, total number of sickness absence days, self-efficacy for RTW and self-reported health. A process evaluation including a realist evaluation will also be conducted. Discussion: Early intervention that focuses on RTW, the cognition towards RTW despite symptoms and involves the workplace environment, plays a crucial role in managing sickness absence among employees with psychological distress. If effective, the stepped-care approach is relevant for employees, employers and society as a whole. Trial Registration: ISRCTN: 90663076. Registered on 5 October 2023. [ABSTRACT FROM AUTHOR]

Background: Older adult women often do not engage in sufficient physical activity (PA) and can encounter biological changes that exacerbate the negative effects of inadequate activity. Wearable activity monitors can facilitate PA initiation, but evidence of sustained behavior change is lacking. Supplementing wearable technologies with intervention content that evokes enjoyment, interest, meaning, and personal values associated with PA may support long term adherence. In this paper, we present the protocol of an NIA-funded study designed to evaluate the efficacy of CHALLENGE for increasing step count and motivation for PA in insufficiently active older women (Challenges for Healthy Aging: Leveraging Limits for Engaging Networked Game-based Exercise). CHALLENGE uses social media to supplement wearable activity monitors with the autonomy-supportive frame of a game. We hypothesize that CHALLENGE will engender playful experiences that will improve motivation for exercise and lead to sustained increases in step count. Methods: We will recruit 300 healthy, community dwelling older adult women on a rolling basis and randomize them to receive either the CHALLENGE intervention (experimental arm) or an activity monitor-only intervention (comparison arm). Participants in both groups will receive a wearable activity monitor and personalized weekly feedback emails. In the experimental group, participants will also be added to a private Facebook group, where study staff will post weekly challenges that are designed to elicit playful experiences while walking. Assessments at baseline and 6, 12, and 18 months will measure PA and motivation-related constructs. We will fit linear mixed-effects models to evaluate differences in step count and motivational constructs, and longitudinal mediation models to evaluate if interventional effects are mediated by changes in motivation. We will also conduct thematic content analysis of text and photos posted to Facebook and transcripts from individual interviews. Discussion: By taking part in a year-long intervention centered on imbuing walking behaviors with playful and celebratory experiences, participating older adult women may internalize changes to their identity and relationship with PA that facilitate sustained behavior change. Study results will have implications for how we can harness powerful and increasingly ubiquitous technologies for health promotion to the vast and growing population of older adults in the U.S. and abroad. Trial registration: ClinicalTrials.gov Identifier NCT04095923. Registered September 17th, 2019. [ABSTRACT FROM AUTHOR]

Background: Loneliness is a serious public health concern. Although previous interventions have had some success in mitigating loneliness, the field is in search of novel, more effective, and more scalable solutions. Here, we focus on "relational agents", a form of software agents that are increasingly powered by artificial intelligence and large language models (LLMs). We report on a systematic review and meta-analysis to investigate the impact of relational agents on loneliness across age groups. Methods: In this systematic review and meta-analysis, we searched 11 databases including Ovid MEDLINE and Embase from inception to Sep 16, 2022. We included randomised controlled trials and non-randomised studies of interventions published in English across all age groups. These loneliness interventions, typically attempt to improve social skills, social support, social interaction, and maladaptive cognitions. Peer-reviewed journal articles, books, book chapters, Master's and PhD theses, or conference papers were eligible for inclusion. Two reviewers independently screened studies, extracted data, and assessed risk of bias via the RoB 2 and ROBINS-I tools. We calculated pooled estimates of Hedge's g in a random-effects meta-analysis and conducted sensitivity and sub-group analyses. We evaluated publication bias via funnel plots, Egger's test, and a trim-and-fill algorithm. Findings: Our search identified 3,935 records of which 14 met eligibility criteria and were included in our meta-analysis. Included studies comprised 286 participants with individual study sample sizes ranging from 4 to 42 participants (x̄ = 20.43, s = 11.58, x̃ = 20). We used a Bonferroni correction with αBonferroni = 0.05 / 4 = 0.0125 and applied Knapp-Hartung adjustments. Relational agents reduced loneliness significantly at an adjusted αBonferroni (g = -0.552; 95% Knapp-Hartung CI, -0.877 to -0.226; P = 0.003), which corresponds to a moderate reduction in loneliness. Conclusion: Our results are currently the most comprehensive of their kind and provide promising evidence for the efficacy of relational agents. Relational agents are a promising technology that can alleviate loneliness in a scalable way and that can be a meaningful complement to other approaches. The advent of LLMs should boost their efficacy, and further research is needed to explore the optimal design and use of relational agents. Future research could also address shortcomings of current results, such as small sample sizes and high risk of bias. Particularly young audiences have been overlooked in past research. [ABSTRACT FROM AUTHOR]

Background: Human papillomavirus (HPV) infections can cause cancers of the cervix, vagina, vulva, penis, anus, and oropharynx. The most recently approved HPV vaccine, Gardasil-9, protects against HPV infection and can prevent HPV-associated invasive cancers. However, Gardasil-9 is one of the most underused vaccines in the US today. Young adults are at risk for HPV infection, but many are not vaccinated. This study uses a randomized controlled trial (RCT) to test an innovative multilevel intervention to increase HPV vaccination rates among young adults. In this paper, we describe the research protocol. Methods: The study uses a two by three factorial design. A total of 1200 young adults in Texas, age 18–26 years, who have not been previously fully vaccinated against HPV will be randomly assigned to one of six conditions to receive: (1) standard CDC information about HPV vaccination (control); (2) video narratives about HPV vaccination; (3) written narratives about HPV vaccination; or (4–6) enhanced access to HPV vaccine combined with (4) standard CDC information, (5) video narratives, or (6) written narratives. The two primary outcomes are the rate of HPV vaccination initiation by 3-month follow-up and rate of HPV vaccination completion by 9-month follow-ups. We will determine the impact of the individual level intervention (i.e., persuasive narratives through video or written format), the systemic level intervention (i.e., enhanced access to HPV vaccines), and the combination of both levels, on HPV vaccination initiation and completion. We will also use purposive sampling to select participants to take part in semi-structured interviews/focus groups to better understand the mechanisms of the intervention. Discussion: Recruitment and data collection began in March 2022. We expect to complete data collection by March 2026. We expect that narratives, enhanced access, and the combination of both will improve HPV vaccination initiation and completion rates among young adults. If proven successful, these individual- and system-level interventions can be easily disseminated in regions with low HPV vaccination rates to improve HPV vaccination, and ultimately decrease HPV-related cancer burden. Trial Registration: NCT05057312. [ABSTRACT FROM AUTHOR]

Background: Given the high rates globally of Type 2 Diabetes Mellitus (T2DM), there is a clear need to target health behaviours through person-centred interventions. Health coaching is one strategy that has been widely recognised as a tool to foster positive behaviour change. However, it has been used inconsistently and has produced mixed results. This systematic review sought to explore the use of behaviour change techniques (BCTs) in health coaching interventions and identify which BCTs are linked with increased effectiveness in relation to HbA1C reductions. Methods: In line with the PICO framework, the review focused on people with T2DM, who received health coaching and were compared with a usual care or active control group on HbA1c levels. Studies were systematically identified through different databases including Medline, Web of science, and PsycINFO searches for relevant randomised controlled trials (RCTs) in papers published between January 1950 and April 2022. The Cochrane collaboration tool was used to evaluate the quality of the studies. Included papers were screened on the reported use of BCTs based on the BCT taxonomy. The effect sizes obtained in included interventions were assessed by using Cohen's d and meta-analysis was used to estimate sample-weighted average effect sizes (Hedges' g). Results: Twenty RCTs with a total sample size of 3222 were identified. Random effects meta-analysis estimated a small-sized statistically significant effect of health coaching interventions on HbA1c reduction (g+ = 0.29, 95% CI: 0.18 to 0.40). A clinically significant HbA1c decrease of ≥5 mmol/mol was seen in eight studies. Twenty-three unique BCTs were identified in the reported interventions, with a mean of 4.5 (SD = 2.4) BCTs used in each study. Of these, Goal setting (behaviour) and Problem solving were the most frequently identified BCTs. The number of BCTs used was not related to intervention effectiveness. In addition, there was little evidence to link the use of specific BCTs to larger reductions in HbA1c across the studies included in the review; instead, the use of Credible source and Social reward in interventions were associated with smaller reductions in HbA1c. Conclusion: A relatively small number of BCTs have been used in RCTs of health coaching interventions for T2DM. Inadequate, imprecise descriptions of interventions and the lack of theory were the main limitations of the studies included in this review. Moreover, other possible BCTs directly related to the theoretical underpinnings of health coaching were absent. It is recommended that key BCTs are identified at an early stage of intervention development, although further research is needed to examine the most effective BCTs to use in health coaching interventions. Trial registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021228567. [ABSTRACT FROM AUTHOR]

Background: The transition from childhood into adolescence can be considered as a critical developmental period. Moreover, adolescence is associated with a decreased use of adaptive emotion regulation strategies and an increased use of maladaptive emotion regulation strategies increasing the risk of emotional problems. Targeting emotion regulation is therefore seen as an innovative prevention approach. The present study aims to evaluate the effectiveness of Boost camp, an innovative school-based prevention program targeting ER, on adolescents' emotion regulation skills and emotional wellbeing. Also secondary outcomes and possible moderators will be included.Methods: The aim is to reach 300 adolescents (16 class groups, 6 schools) in their first year of high school. A clustered Randomized Controlled Trial (RCT) with two conditions, intervention (n = 150) and control (n = 150), will be set up. Adolescents in the intervention condition will receive 14 lessons over the course of 2 days, followed by Booster sessions, and will be compared with adolescents in a non-intervention control group. The outcomes will be measured by self-report questionnaires at baseline, immediately after Boost camp, and at three and 6 months follow-up.Discussion: Data-collection is planned to be completed in May 2018. Data-analyses will be finished the end of 2018. The presented paper describes the Boost camp program and the clustered RCT design to evaluate its effectiveness. It is expected that Boost camp will have beneficial effects. If found effective, Boost camp will have the potential to increase adolescent's ER and well-being, and reduce the risk to become adults in need. The trials is registered on the 13th of June 2017 in ISRCTN registry [ISRCTN68235634]. [ABSTRACT FROM AUTHOR]

Background: Lung cancer is the leading cause of cancer death for both men and women in the United States. The National Lung Screening Trial (NLST) demonstrated that low-dose computed tomography (LDCT) screening can reduce lung cancer mortality among high-risk individuals, but uptake of lung screening remains low. Social media platforms have the potential to reach a large number of people, including those who are at high risk for lung cancer but who may not be aware of or have access to lung screening. Methods: This paper discusses the protocol for a randomized controlled trial (RCT) that leverages FBTA to reach screening-eligible individuals in the community at large and intervene with a public-facing, tailored health communication intervention (LungTalk) to increase awareness of, and knowledge about, lung screening. Discussion: This study will provide important information to inform the ability to refine implementation processes for national population efforts to scale a public-facing health communication focused intervention using social media to increase screening uptake of appropriate, high-risk individuals. Trial registration: The trial is registered at clinicaltrials.gov (#NCT05824273). [ABSTRACT FROM AUTHOR]

Background: Mobile Health ("mHealth") interventions have shown promise in improving HIV treatment outcomes for stigmatized populations. This paper presents the findings from a randomized controlled trial to assess the efficacy, participant-level feasibility and acceptability of a theory-informed mHealth intervention, Motivation Matters!, designed to improve viral suppression and ART adherence among HIV-seropositive women who engage in sex work in Mombasa, Kenya. Methods: A total of 119 women were randomized between the intervention and standard of care control. The primary outcome examined viral suppression (≤ 30 copies/mL) six months following ART initiation. ART adherence was assessed monthly using a visual analogue scale. Participant-level feasibility was measured through response rates to study text messages. Acceptability was assessed through qualitative exit interviews. Results: Six months following treatment initiation, 69% of intervention and 63% of control participants were virally suppressed (Risk Ratio [RR] = 1.09, 95% Confidence Interval [95% CI] (0.83, 1.44). Among women who were viremic at baseline and endorsed engagement in sex work, 74% of women in the intervention arm compared with 46% of women in the control arm achieved viral suppression at month six RR = 1.61, 95% CI (1.02, 2.55). Adherence was higher in intervention versus control participants every month. All participants responded to at least one message, and there was a 55% overall response rate to intervention text messages. Qualitative exit interviews suggested high acceptability and perceived impact of the intervention. Conclusion: The improvements in ART adherence and viral suppression, combined with encouraging data on feasibility and acceptability, provides preliminary evidence that Motivation Matters! could support ART adherence and viral suppression in women who engage in sex work. Trial registration: This trial was registered with ClinicalTrials.gov (NCT02627365, 10/12/2015; http://clinicaltrials.gov). [ABSTRACT FROM AUTHOR]

Background: Numerous observational studies show associations between family meal frequency and markers of child cardiovascular health including healthful diet quality and lower weight status. Some studies also show the "quality" of family meals, including dietary quality of the food served and the interpersonal atmosphere during meals, is associated with markers of child cardiovascular health. Additionally, prior intervention research indicates that immediate feedback on health behaviors (e.g., ecological momentary intervention (EMI), video feedback) increases the likelihood of behavior change. However, limited studies have tested the combination of these components in a rigorous clinical trial. The main aim of this paper is to describe the Family Matters study design, data collection protocols, measures, intervention components, process evaluation, and analysis plan. Methods/design: The Family Matters intervention utilizes state-of-the-art intervention methods including EMI, video feedback, and home visiting by Community Health Workers (CHWs) to examine whether increasing the quantity (i.e., frequency) and quality of family meals (i.e., diet quality, interpersonal atmosphere) improves child cardiovascular health. Family Matters is an individual randomized controlled trial that tests combinations of the above factors across three study Arms: (1) EMI; (2) EMI + Virtual Home Visiting with CHW + Video Feedback; and (3) EMI + Hybrid Home Visiting with CHW + Video Feedback. The intervention will be carried out across 6 months with children ages 5–10 (n = 525) with increased risk for cardiovascular disease (i.e., BMI ≥ 75%ile) from low income and racially/ethnically diverse households and their families. Data collection will occur at baseline, post-intervention, and 6 months post-intervention. Primary outcomes include child weight, diet quality, and neck circumference. Discussion: This study will be the first to our knowledge to use multiple innovative methods simultaneously including ecological momentary intervention, video feedback, and home visiting with CHWs within the novel intervention context of family meals to evaluate which combination of intervention components are most effective in improving child cardiovascular health. The Family Matters intervention has high potential public health impact as it aims to change clinical practice by creating a new model of care for child cardiovascular health in primary care. Trial registration: This trial is registered in clinicaltrials.gov (Trial ID: NCT02669797). Date recorded 5/02/22. [ABSTRACT FROM AUTHOR]

Background: A randomised trial of European Fans in Training (EuroFIT), a 12-week healthy lifestyle program delivered in 15 professional football clubs in the Netherlands, Norway, Portugal, and the United Kingdom, successfully increased physical activity and improved diet but did not reduce sedentary time. To guide future implementation, this paper investigates how those effects were achieved. We ask: 1) how was EuroFIT implemented? 2) what were the processes through which outcomes were achieved? Methods: We analysed qualitative data implementation notes, observations of 29 of 180 weekly EuroFIT deliveries, semi-structured interviews with 16 coaches and 15 club representatives, and 30 focus group discussions with participants (15 post-program and 15 after 12 months). We descriptively analysed quantitative data on recruitment, attendance at sessions and logs of use of the technologies and survey data on the views of participants at baseline, post program and after 12 months. We used a triangulation protocol to investigate agreement between data from difference sources, organised around meeting 15 objectives within the two research questions. Results: We successfully recruited clubs, coaches and men to EuroFIT though the draw of the football club seemed stronger in the UK and Portugal. Advertising that emphasized getting fitter, club-based deliveries, and not 'standing out' worked and attendance and fidelity were good, so that coaches in all countries were able to deliver EuroFIT flexibly as intended. Coaches in all 15 clubs facilitated the use of behaviour change techniques and interaction between men, which together enhanced motivation. Participants found it harder to change sedentary time than physical activity and diet. Fitting changes into daily routines, planning for setbacks and recognising the personal benefit of behaviour change were important to maintain changes. Bespoke technologies were valued, but technological hitches frustrated participants. Conclusion: EuroFIT was delivered as planned by trained club coaches working flexibly in all countries. It worked as expected to attract men and support initiation and maintenance of changes in physical activity and diet but the use of bespoke, unstable, technologies was frustrating. Future deliveries should eliminate the focus on sedentary time and should use only proven technologies to support self-monitoring and social interaction. Trial registration: ISRCTN81935608, registered 16/06/2015. [ABSTRACT FROM AUTHOR]

Background: Clinical practice guidelines recommend that adults with type 2 diabetes (T2D) sit less and move more throughout the day. The 18-month OPTIMISE Your Health Clinical Trial was developed to support desk-based workers with T2D achieve these recommendations. The two-arm protocol consists of an intervention and control arms. The intervention arm receives 6 months health coaching, a sit-stand desktop workstation and an activity tracker, followed by 6 months of text message support, then 6 months maintenance. The control arm receives a delayed modified intervention after 12 months of usual care. This paper describes the methods of a randomised controlled trial (RCT) evaluating the effectiveness and cost-effectiveness of the intervention, compared to a delayed intervention control.Methods: This is a two-arm RCT being conducted in Melbourne, Australia. Desk-based workers (≥0.8 full-time equivalent) aged 35-65 years, ambulatory, and with T2D and managed glycaemic control (6.5-10.0% HbA1c), are randomised to the multicomponent intervention (target n = 125) or delayed-intervention control (target n = 125) conditions. All intervention participants receive 6 months of tailored health coaching assisting them to "sit less" and "move more" at work and throughout the day, supported by a sit-stand desktop workstation and an activity tracker (Fitbit). Participants receive text message-based extended care for a further 6-months (6-12 months) followed by 6-months of non-contact (12-18 months: maintenance). Delayed intervention occurs at 12-18 months for the control arm. Assessments are undertaken at baseline, 3, 6, 12, 15 and 18-months. Primary outcomes are activPAL-measured sitting time (h/16 h day), glycosylated haemoglobin (HbA1c; %, mmol/mol) and, cognitive function measures (visual learning and new memory; Paired Associates Learning Total Errors [adjusted]). Secondary, exploratory, and process outcomes will also be collected throughout the trial.Discussion: The OPTIMISE Your Health trial will provide unique insights into the benefits of an intervention aimed at sitting less and moving more in desk-bound office workers with T2D, with outcomes relevant to glycaemic control, and to cardiometabolic and brain health. Findings will contribute new insights to add to the evidence base on initiating and maintaining behaviour change with clinical populations and inform practice in diabetes management.Trial Registration: ANZCTRN12618001159246 . [ABSTRACT FROM AUTHOR]

Background: Up to 20% of UK children experience socio-emotional difficulties which can have serious implications for themselves, their families and society. Stark socioeconomic and ethnic inequalities in children's well-being exist. Supporting parents to develop effective parenting skills is an important preventive strategy in reducing inequalities. Parenting interventions have been developed, which aim to reduce the severity and impact of these difficulties. However, most parenting interventions in the UK focus on early childhood (0-10 years) and often fail to engage families from ethnic minority groups and those living in poverty. Strengthening Families, Strengthening Communities (SFSC) is a parenting programme designed by the Race Equality Foundation, which aims to address this gap. Evidence from preliminary studies is encouraging, but no randomised controlled trials have been undertaken so far.Methods/design: The TOGETHER study is a multi-centre, waiting list controlled, randomised trial, which aims to test the effectiveness of SFSC in families with children aged 3-18 across seven urban areas in England with ethnically and socially diverse populations. The primary outcome is parental mental well-being (assessed by the Warwick-Edinburgh Mental Well-Being Scale). Secondary outcomes include child socio-emotional well-being, parenting practices, family relationships, self-efficacy, quality of life, and community engagement. Outcomes are assessed at baseline, post intervention, three- and six-months post intervention. Cost effectiveness will be estimated using a cost-utility analysis and cost-consequences analysis. The study is conducted in two stages. Stage 1 comprised a 6-month internal pilot to determine the feasibility of the trial. A set of progression criteria were developed to determine whether the stage 2 main trial should proceed. An embedded process evaluation will assess the fidelity and acceptability of the intervention.Discussion: In this paper we provide details of the study protocol for this trial. We also describe challenges to implementing the protocol and how these were addressed. Once completed, if beneficial effects on both parental and child outcomes are found, the impact, both immediate and longer term, are potentially significant. As the intervention focuses on supporting families living in poverty and those from minority ethnic communities, the intervention should also ultimately have a beneficial impact on reducing health inequalities.Trial Registration: Prospectively registered Randomised Controlled Trial ISRCTN15194500 . [ABSTRACT FROM AUTHOR]

Background: Globally COVID-19 has had a profound impact on the psychological wellbeing of millions of people, and there is an urgent imperative to address elevated levels of distress during the COVID-19 pandemic. The World Health Organization (WHO) has developed Problem Management Plus (PM+), a low intensity psychological intervention for adults experiencing psychological distress. This paper outlines the study protocol for a trial that tests the effectiveness of an adapted version of PM+ to reduce distress associated with COVID-19.Methods: A single-blind, parallel, randomized controlled trial will be carried out for distressed people across Australia. via video conferencing on a small group basis. Following informed consent, adults that screen positive for levels of psychological distress (General Health Questionnaire-12 (GHQ-12 score ≥ 3) and have access to videoconferencing platform will be randomised to an adapted version of gPM+ (n = 120) or enhanced treatment as usual (ETAU) (n = 120). The primary outcome will be reduction in psychological distress including anxiety and depression at 2-months post treatment. Secondary outcomes include worry, sleep problems, anhedonia, social support, and stress in relation to COVID-19.Discussion: The trial aims assess whether an adapted version of videoconferencing PM+ that is specifically designed to target COVI-19 related distress will result in reduced distress relative to enhanced usual care.Trial Registration: This trial was prospectively registered on the ANZCTR on 14/4/20 ( ACTRN12620000468921 ). [ABSTRACT FROM AUTHOR]

Background: Poor adherence to antiretroviral therapy (ART) is one of the primary barriers to viral load suppression. mHealth technology can help overcome challenges with ART adherence. This paper outlines the protocol for the WiseApp randomized control trial. The WiseApp contains real-time medication monitoring linking an electronic pill bottle and fitness tracker to the app, helping persons living with HIV (PLWH) self-manage their medication adherence and improve their overall quality of life. The primary objective of the trial is to test the effect of the WiseApp's medication adherence features on antiretroviral adherence in underserved PLWH in New York City.Methods: This ongoing study is a two-arm randomized control trial. Participants are randomized 1:1 to the WiseApp intervention arm or the control arm at baseline and followed for 6 months. Eligibility criteria include: 18 years of age, have a diagnosis of HIV, speak and understand English or Spanish, live in the United States, own a smartphone, currently taking ART medications, and report the past 30 days adherence of 80% or less as measured using the Visual Analogue Scale (VAS), or have a viral load of over 400 copies/mL. The sample size for the trial is 200 people. All study participants receive the WiseApp, a CleverCap electronic pill bottle, and a fitness tracker. The intervention group also receives videos and health surveys centered on medication adherence and managing living with HIV as well as medication reminders. In contrast, the control group receives walk step reminders, videos, and surveys focused on overall wellness.Discussion: The WiseApp Trial has the potential to improve HIV self-management applications, being one of the few randomized controlled trials of a mHealth medication adherence and HIV self-management application in the United States. The trial could also bring new opportunities for advancement in reaching economically disenfranchised and underserved populations in the United States. The real-time monitoring of the WiseApp has the potential to help providers initiate interventions to help patients resume treatment before drug resistance begins.Trial Registration: This trial was registered with ClinicalTrials.gov ( NCT03205982 ) on July 2, 2017. [ABSTRACT FROM AUTHOR]

Evidence of the impact of community-based nutrition programs is uncommon for two main reasons: the lack of untreated controls, and implementation does not account for the evaluation design. Suchana is a large-scale program to prevent malnutrition in children in Sylhet division, Bangladesh by improving the livelihoods and nutrition knowledge of poor and very poor households. Suchana is being implemented in 157 unions, the smallest administrative unit of government, in two districts of Sylhet. Suchana will deliver a package of interventions to poor people in about 40 randomly selected new unions annually over 4 years, until all are covered. All beneficiaries will receive the normal government nutrition services. For evaluation purposes the last 40 unions will act as a control for the first 40 intervention unions. The remaining unions will receive the program but will not take part in the evaluation. A baseline survey was conducted in both intervention and control unions; it will be repeated after 3 years to estimate the impact on the prevalence of stunted children and other indicators. This stepped wedge design has several advantages for both the implementation and evaluation of services, as well as some disadvantages. The units of delivery are randomized, which controls for other influences on outcomes; the program supports government service delivery systems, so it is replicable and scalable; and the program can be improved over time as lessons are learned. The main disadvantages are the difficulty of estimating the impact of each component of the program, and the geographical distribution of unions, which increases program delivery costs. Stepped implementation allows a cluster randomized trial to be achieved within a large-scale poverty alleviation program and phased-in and scaled-up over a period of time. This paper may encourage evaluators to consider how to estimate attributable impact by using stepped implementation, which allows the counterfactual group eventually to be treated. [ABSTRACT FROM AUTHOR]

Background: Accessing quality mental health care poses significant challenges for persons affected by adversity, especially in low- and middle-income countries where resources are scarce. To mitigate this, the World Health Organization has developed group problem management plus (gPM+), a low-intensity psychological intervention for adults experiencing psychological distress. gPM+ is a group-based intervention consisting of five-sessions, and can be delivered by non-specialist providers. This paper outlines the study protocol for a trial of gPM+ in Jordan.Methods: We will conduct a single-blind, two-arm, randomized controlled trial in a Syrian refugee camp in Jordan. We aim to enrol 480 adults into the trial. Participants will be eligible for the trial if they screen positive for levels of psychological distress. Following screening, those eligible will be randomly assigned to receive the gPM+ intervention or enhanced treatment as usual. The primary outcome is reduction in levels of psychological distress at 3-months post-treatment. Secondary outcomes include anxiety, depression, prodromal psychotic symptoms, posttraumatic stress disorder, prolonged grief, daily functioning, economic effectiveness, and change in parenting behaviour. Secondary outcomes also include the reduction in psychological distress of the participant's child.Discussion: The trial aims to deliver a template for affordable and scalable psychosocial interventions that can readily be implemented in refugee settings, and that can benefit both the participant and their child.Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12619001386123. Registered prospectively on 10/10/2019. [ABSTRACT FROM AUTHOR]

Background: Young people account for more than a quarter of new HIV infections in the US, with the majority of cases among young men who have sex with men; young transgender women are also vulnerable to infection. Substance use, particularly alcohol misuse, is a driver of sexual transmission and a potential barrier to engagement in the HIV prevention and care continuum, however vulnerable youth are difficult to reach for substance use services due, in part, to complex social and structural factors and limited access to health care. The Community Prevention Services Task Force recommends electronic screening and brief intervention as an evidence-based intervention for the prevention of excessive alcohol consumption; however, no prior studies have extended this model to community-based populations of youth that are susceptible to HIV infection. This paper describes the study protocol for an electronic screening and brief intervention to reduce alcohol misuse among adolescents and young adults vulnerable to HIV infection in community-based settings.Methods: This study, Step Up, Test Up, is a randomized controlled trial of an electronic alcohol screening and brief intervention among youth, ages 16-25, who are vulnerable to HIV infection. Individuals who present for HIV testing at one of three community-based locations are recruited for study participation. Eligibility includes those aged 16-25 years, HIV-negative or unknown HIV status, male or trans female with a history of sex with men, and English-speaking. Participants who screen at moderate to high risk for alcohol misuse on the Alcohol Use Disorders Identification Test (AUDIT) are randomized (1:1) to either an electronic brief intervention to reduce alcohol misuse or a time-and attention-matched control. The primary outcome is change in the frequency/quantity of recent alcohol use at 1, 3, 6 and 12-month follow-up.Discussion: Testing of evidence-based interventions to reduce alcohol misuse among youth vulnerable to HIV infection are needed. This study will provide evidence to determine feasibility and efficacy of a brief electronically-delivered intervention to reduce alcohol misuse for this population.Trial Registration: ClinicalTrials.gov number, NCT02703116, registered March 9, 2016. [ABSTRACT FROM AUTHOR]

Background: Control of blood pressure among hypertensives is a major challenge around the world. Interventions for improving hypertension control in India are very limited. This paper describes the protocol for a cluster randomized controlled trial of efficacy of behavioural intervention on control of hypertension among school teachers in Kerala.Methods: A total of 92 schools are randomised to intervention and control group in Kerala. A baseline survey was conducted in all schools to assess the prevalence of hypertension and its risk factors among school teachers in Thiruvananthapuram district of Kerala state, India. Teachers in both sets of schools will receive a leaflet containing details on the importance of controlling hypertension. With the objective of improving control of hypertension, the intervention schools will additionally receive self-management education and behavioural intervention programs delivered by trained intervention managers along with measurement of weight, waist circumference and blood pressure. This intervention program will be developed based on the findings of the baseline survey and selected components of successful models of hypertension control from previous research done in similar settings. The intervention will be given for 3 months after which a post-survey will be conducted among teachers of both control and intervention schools. The primary outcome is change in control of hypertension and secondary outcome is the change in behavioural risk factors of hypertension both in the control and intervention groups.Discussion: This is the first comprehensive study looking at the efficacy of behavioural intervention on hypertension control among school teachers in Kerala, India. This study is likely to provide an upper estimate of behavioural intervention on hypertension control since teachers are reported to have one of the highest compliance rates of behavioural intervention.Trial Registration: This trial was prospectively registered with the Clinical Trials Registry of India [CTRI/2018/01/011402] on 18 January 2018. [ABSTRACT FROM AUTHOR]

Vector-borne diseases are among the most burdensome infectious diseases worldwide with high burden to health systems in developing regions in the tropics. For many of these diseases, vector control to reduce human biting rates or arthropod populations remains the primary strategy for prevention. New vector control interventions intended to be marketed through public health channels must be assessed by the World Health Organization for public health value using data generated from large-scale trials integrating epidemiological endpoints of human health impact. Such phase III trials typically follow large numbers of study subjects to meet necessary power requirements for detecting significant differences between treatment arms, thereby generating substantive and complex datasets. Data is often gathered directly in the field, in resource-poor settings, leading to challenges in efficient data reporting and/or quality assurance. With advancing technology, mobile data collection (MDC) systems have been implemented in many studies to overcome these challenges. Here we describe the development and implementation of a MDC system during a randomized-cluster, placebo-controlled clinical trial evaluating the protective efficacy of a spatial repellent intervention in reducing human infection with Aedes-borne viruses (ABV) in the urban setting of Iquitos, Peru, as well as the data management system that supported it. We discuss the benefits, remaining capacity gaps and the key lessons learned from using a MDC system in this context in detail. [ABSTRACT FROM AUTHOR]

Background: The Bristol Girls Dance Project was a cluster randomised controlled trial that aimed to increase objectively measured moderate-to-vigorous physical activity (MVPA) levels of Year 7 (age 11-12) girls through a dance-based after-school intervention. The intervention was delivered in nine schools and consisted of up to forty after-school dance sessions. This paper reports on the main findings from the detailed process evaluation that was conducted.Methods: Quantitative and qualitative data were collected from intervention schools. Dose and fidelity were reported by dance instructors at every session. Intervention dose was defined as attending two thirds of sessions and was measured by attendance registers. Fidelity to the intervention manual was reported by dance instructors. On four randomly-selected occasions, participants reported their perceived level of exertion and enjoyment. Reasons for non-attendance were self-reported at the end of the intervention. Semi-structured interviews were conducted with all dance instructors who delivered the intervention (n = 10) and school contacts (n = 9) in intervention schools. A focus group was conducted with girls who participated in each intervention school (n = 9).Results: The study did not affect girls' MVPA. An average of 31.7 girls participated in each school, with 9.1 per school receiving the intervention dose. Mean attendance and instructors' fidelity to the intervention manual decreased over time. The decline in attendance was largely attributed to extraneous factors common to after-school activities. Qualitative data suggest that the training and intervention manual were helpful to most instructors. Participant ratings of session enjoyment were high but perceived exertion was low, however, girls found parts of the intervention challenging.Conclusions: The intervention was enjoyed by participants. Attendance at the intervention sessions was low but typical of after-school activities. Participants reported that the intervention brought about numerous health and social benefits and improved their dance-based knowledge and skills. The intervention could be improved by reducing the number of girls allowed to participate in each school and providing longer and more in-depth training to those delivering the intervention.Trial Registration: ISRCTN52882523 Registered 25th April 2013. [ABSTRACT FROM AUTHOR]

Background: Partner support is associated with better weight loss outcomes in observational studies, but randomized trials show mixed results for including partners. Unclear is whether teaching communication skills to couples will improve weight loss in a person attempting weight loss (index participant). Purpose: To compare the efficacy of a partner-assisted intervention versus participant-only weight management program on 24-month weight loss. Methods: This community-based study took place in Madison, WI. Index participants were eligible if they met obesity guideline criteria to receive weight loss counseling, were aged 18–74 years, lived with a partner, and had no medical contraindications to weight loss; partners were aged 18–74 years and not underweight. Couples were randomized 1:1 to a partner-assisted or participant-only intervention. Index participants in both arms received an evidence-based weight management program. In the partner-assisted arm, partners attended half of the intervention sessions, and couples were trained in communication skills. The primary outcome was index participant weight at 24 months, assessed by masked personnel; secondary outcomes were 24-month self-reported caloric intake and average daily steps assessed by an activity tracker. General linear mixed models were used to compare group differences in these outcomes following intent-to-treat principles. Results: Among couples assigned to partner-assisted (n = 115) or participant-only intervention (n = 116), most index participants identified as female (67%) and non-Hispanic White (87%). Average baseline age was 47.27 years (SD 11.51 years) and weight was 106.55 kg (SD 19.41 kg). The estimated mean 24-month weight loss was similar in the partner-assisted (2.66 kg) and participant-only arms (2.89 kg) (estimated mean difference, 0.23 kg [95% CI, -1.58, 2.04 kg], p=0.80). There were no differences in 24-month average daily caloric intake (estimated mean difference 50 cal [95% CI: -233, 132 cal], p=0.59) or steps (estimated mean difference 806 steps [95% CI: -1675, 64 steps], p=0.07). The percentage of participants reporting an adverse event with at least possible attribution to the intervention did not differ by arm (partner-assisted: 9%, participant-only, 3%, p = 0.11). Conclusions: Partner-assisted and individual weight management interventions led to similar outcomes in index participants. Trial registration: Clinicaltrials.gov NCT03801174, January 11, 2019. [ABSTRACT FROM AUTHOR]

Teachers' mental health literacy (MHL) is fundamental for recognizing and assisting students with mental disorders. The aim of this study was to assess the effectiveness of the World Health Organization School Mental Health Program (WHO-SMHP) in promoting MHL among secondary schools' teachers in Qatar. We conducted a two-arm randomized control trial. Teachers working in governmental secondary schools were eligible for selection. A total of 16 schools (8 intervention, 8 control) randomly selected and stratified by gender then randomly assigned (1:1). Participants and study team were aware of group assignment. Assessment of teachers' MHL was at day 0, 3 then 3 months afterward. Bivariat analysis and Generalized Estimating Equations were used in analysis. The primary outcome was teachers MHL. Secondary outcome was the influence of sociodemographic characteristics on the level of MHL. Between October 30, 2018 and March 21, 2019, we randomly assigned 195 teachers from 16 schools to attend training workshop on WHO-SMHP (n = 95) or usual practice (n = 100). Compared with controls, teachers from intervention group demonstrated a significant improvement in the level of MHL at day three (mean difference = 19.1, 95% CI = 17.0–21.2, Cohen's d = 2.63; p < 0.001).) and after three months (mean difference 16.61, 95% CI = 13.96–19.26, Cohen's d = 1.86; p < 001). There were no significant differences related to influence of other variables on MHL. To our knowledge, this is the first trial to prove the effectiveness of the (WHO-SMHP) in promoting teachers MHL, which can be successfully implemented in a wider scale. [ABSTRACT FROM AUTHOR]

Background: Aboriginal and Torres Strait Islander communities in remote Australia have initiated bold policies for health-enabling stores. Benchmarking, a data-driven and facilitated 'audit and feedback' with action planning process, provides a potential strategy to strengthen and scale health-enabling best-practice adoption by remote community store directors/owners. We aim to co-design a benchmarking model with five partner organisations and test its effectiveness with Aboriginal and Torres Strait Islander community stores in remote Australia. Methods: Study design is a pragmatic randomised controlled trial with consenting eligible stores (located in very remote Northern Territory (NT) of Australia, primary grocery store for an Aboriginal community, and serviced by a Nutrition Practitioner with a study partner organisation). The Benchmarking model is informed by research evidence, purpose-built best-practice audit and feedback tools, and co-designed with partner organisation and community representatives. The intervention comprises two full benchmarking cycles (one per year, 2022/23 and 2023/24) of assessment, feedback, action planning and action implementation. Assessment of stores includes i adoption status of 21 evidence-and industry-informed health-enabling policies for remote stores, ii implementation of health-enabling best-practice using a purpose-built Store Scout App, iii price of a standardised healthy diet using the Aboriginal and Torres Strait Islander Healthy Diets ASAP protocol; and, iv healthiness of food purchasing using sales data indicators. Partner organisations feedback reports and co-design action plans with stores. Control stores receive assessments and continue with usual retail practice. All stores provide weekly electronic sales data to assess the primary outcome, change in free sugars (g) to energy (MJ) from all food and drinks purchased, baseline (July-December 2021) vs July-December 2023. Discussion: We hypothesise that the benchmarking intervention can improve the adoption of health-enabling store policy and practice and reduce sales of unhealthy foods and drinks in remote community stores of Australia. This innovative research with remote Aboriginal and Torres Strait Islander communities can inform effective implementation strategies for healthy food retail more broadly. Trial registration: ACTRN12622000596707, Protocol version 1. [ABSTRACT FROM AUTHOR]

Background: Childhood obesity has become an alarming worldwide increasing public health problem. The earlier adiposity rebound occurs, the greater the risk of becoming obese during puberty and adolescence. It has been speculated about the potential influence of vigorous physical activity on modifying the age of onset of adiposity rebound. Moreover, studies aimed to evaluate the effectiveness of physical activity interventions programs on reducing adiposity and other cardiovascular risk factors in children younger than 6 years are scarce. This paper describes the rationale and methods of a study aimed to test the effectiveness of a two-years multidimensional pre-school intervention on preventing obesity and improving physical fitness during the adiposity rebound period. Methods/Design: Twenty-one schools from the provinces of Cuenca and Ciudad Real, Spain, were randomised to an intervention and a control arm. In the first academic year, children in third grade of pre-school and first grade of primary school in the intervention group received the physical activity intervention (MOVI-KIDS). After an academic year schools were crossed over to the alternative arm. According to the socio-ecological model, the intervention included children, their parents and teachers, and the school environment where MOVI-KIDS was conducted. MOVI-KIDS consisted of: i) three-h/week sessions of recreational non-competitive physical activity in after-school time; ii) educational materials to parents and teachers about physical activity benefits and sedentary lifestyle risks; and iii) modifications in the playground to promote physical activity during recess. Baseline and post-intervention outcomes are going to be measured in both arms three times, at the beginning and at the end of first academic year, and at the end of the second academic year. Primary outcomes included body mass index, waist circumference, triceps skinfold thickness, percentage of both body fat and fat-free mass, and blood pressure. Secondary end points were physical activity, fitness, and carotid intima-media thickness. Discussion: This paper reports the design of a randomised cross-over cluster trial aimed at assessing the effectiveness of the multidimensional physical activity intervention (MOVI-KIDS) during two years in pre-school children. [ABSTRACT FROM AUTHOR]

Background: Point-of-sale is a potentially important opportunity to promote healthy eating through nutrition education and environment modification. The aim of this review was to describe and review the evidence of effectiveness of various types of interventions that have been used at point-of-sale to encourage purchase and/or eating of healthier food and to improve health outcomes, and the extent to which effectiveness was related to intensity, duration and intervention setting. Methods: Records from searches in databases were screened and assessed against inclusion criteria. Included studies had risk of bias assessed. Intervention effectiveness was assessed for two outcomes: i) purchase and/or intake of healthier food options and/or nutrient intake; and ii) mediating factors that might effect the primary outcome. Results: The search identified 5635 references. Thirty-two papers met the inclusion criteria. Twelve studies had low risk of bias and were classified as strong, nine were moderate and 11 were weak. Six intervention types and a range of different outcome measures were described in these papers: i) nutrition education and promotion alone through supermarkets/stores; ii) nutrition education plus enhanced availability of healthy food; iii) monetary incentive alone; iv) nutrition education plus monetary incentives; v) nutrition intervention through vending machines; and vi) nutrition intervention through shopping online. The evidence of this review indicates that monetary incentives offered to customers for a short-term look promising in increasing purchase of healthier food options when the intervention is applied by itself in stores or supermarkets. There was a lack of good quality studies addressing all other types of relevant point-of-sale interventions examining change in purchase and/or intake of healthier food options. There were few studies that examined mediating factors that might mediate the effect on the primary outcomes of relevant interventions. Conclusions: A range of intervention types have been used at point-of-sale to encourage healthy purchasing and/or intake of healthier food options and to improve health outcomes. There is a need for more well designed studies on the effectiveness of a range of point-of-sale interventions to encourage healthier eating and improve health outcomes, and of the mediating factors that might impact these interventions. [ABSTRACT FROM AUTHOR]

Background Obesity prevention is a major public health priority. Despite the health risks associated with weight gain, there has been a distinct lack of research into effective interventions to prevent, rather than treat, obesity particularly at high risk life stages such as menopause in women. This paper describes the rationale for and design of a 2-year randomized controlled trial (RCT) (the 40-Something Study) aimed at testing the feasibility and efficacy of a relatively low intensity intervention designed to achieve weight control in non-obese women about to enter the menopause transition. Methods and design The study is a parallel-group RCT consisting of 12 months of intervention (Phase 1) and 12 months of monitoring (Phase 2). Non-obese pre-menopausal healthy females 44-50 years of age were screened, stratified according to Body Mass Index (BMI) category (18.5-24.9 and 25-29.9 kg/m²) and randomly assigned to one of two groups: motivational interviewing (MI) intervention (n = 28), or a self-directed intervention (SDI) (control) (n = 26). The MI intervention consisted of five consultations with health professionals (four with a Dietitian and one with an Exercise Physiologist) who applied components of MI counselling to consultations with the women over a 12 month period. The SDI was developed as a control and these participants received print materials only. Outcome measures were collected at baseline, three, 12, 18 and 24 months and included weight (primary outcome), waist circumference, body composition, blood pressure, plasma markers of metabolic syndrome risk, dietary intake, physical activity and quality of life. Analysis of covariance will be used to investigate outcomes according to intervention type and duration (comparing baseline, 12 and 24 months). Discussion The 40-Something study is the first RCT aimed at preventing menopausal weight gain in Australian women. Importantly, this paper describes the methods used to evaluate whether a relatively low intensity, health professional led intervention will achieve better weight control in pre-menopausal women than a self-directed intervention. The results will add to the scant body of literature on obesity prevention methods at an under-researched high-risk life stage, and inform the development of population-based interventions. [ABSTRACT FROM AUTHOR]

Background: Exposure to sunlight can have both positive and negative health impacts. Excessive exposure to ultra-violet (UV) radiation from the sun can cause skin cancer, however insufficient exposure to sunlight has a detrimental effect on production of Vitamin D. In the construction industry there are onsite proactive behaviours for safety, but sun-safety remains a low priority. There is limited research on understanding the barriers to adopting sun-safe behaviours and the association this may have with Vitamin D production. This paper reports a protocol for an intervention study, using text messaging in combination with a supportive smartphone App. The intervention aims to both reduce UV exposure during months with higher UV levels and promote appropriate dietary changes to boost Vitamin D levels during months with low UV levels.Method/design: Approximately 60 construction workers will be recruited across the United Kingdom. A randomised control crossover trial (RCCT) will be used to test the intervention, with randomisation at site level - i.e. participants will receive both the control (no text messages or supportive App support) and intervention (daily text messages and supportive App). Using the Theory of Planned Behaviour (TPB) the intervention focuses on supporting sun-safety and healthy dietary decisions in relation to Vitamin D intake. The intervention emphasises cultivating the perception of normative support in the workplace, increasing awareness of control and self-efficacy in taking sun-protective behaviours, making healthier eating choices to boost Vitamin D, and tackling stigmas attached to image and group norms. Each study epoch will last 21 days with intervention text messages delivered on workdays only. The supportive App will provide supplementary information about sun protective behaviours and healthy dietary choices. The primary outcome measure is 25-hydroxy-Vitamin D [25(OH)D] level (obtained using blood spot sampling), which will be taken pre and post control and intervention periods. Secondary outcome measures are two-fold, (1) using the TPB to detect changes in behaviour, and (2) quantifying UV exposure during the UK peak radiation season (April-September) using body-mounted UV sensors.Discussion: This study will provide important information about the effectiveness of a technology-based intervention to promote sun-safety and healthy behaviours in outdoor construction workers.Trial Registration: ISRCTN15888934 retrospectively registered 15.01.2018. [ABSTRACT FROM AUTHOR]

Background: Translation encompasses the continuum from clinical efficacy to widespread adoption within the healthcare service and ultimately routine clinical practice. The Parenting, Eating and Activity for Child Health (PEACH™) program has previously demonstrated clinical effectiveness in the management of child obesity, and has been recently implemented as a large-scale community intervention in Queensland, Australia. This paper aims to describe the translation of the evaluation framework from a randomised controlled trial (RCT) to large-scale community intervention (PEACH™ QLD). Tensions between RCT paradigm and implementation research will be discussed along with lived evaluation challenges, responses to overcome these, and key learnings for future evaluation conducted at scale.Methods: The translation of evaluation from PEACH™ RCT to the large-scale community intervention PEACH™ QLD is described. While the CONSORT Statement was used to report findings from two previous RCTs, the REAIM framework was more suitable for the evaluation of upscaled delivery of the PEACH™ program. Evaluation of PEACH™ QLD was undertaken during the project delivery period from 2013 to 2016.Results: Experiential learnings from conducting the evaluation of PEACH™ QLD to the described evaluation framework are presented for the purposes of informing the future evaluation of upscaled programs. Evaluation changes in response to real-time changes in the delivery of the PEACH™ QLD Project were necessary at stages during the project term. Key evaluation challenges encountered included the collection of complete evaluation data from a diverse and geographically dispersed workforce and the systematic collection of process evaluation data in real time to support program changes during the project.Conclusions: Evaluation of large-scale community interventions in the real world is challenging and divergent from RCTs which are rigourously evaluated within a more tightly-controlled clinical research setting. Constructs explored in an RCT are inadequate in describing the enablers and barriers of upscaled community program implementation. Methods for data collection, analysis and reporting also require consideration. We present a number of experiential reflections and suggestions for the successful evaluation of future upscaled community programs which are scarcely reported in the literature.Trials Registration: PEACH™ QLD was retrospectively registered with the Australian New Zealand Clinical Trials Registry on 28 February 2017 (ACTRN12617000315314). [ABSTRACT FROM AUTHOR]

Introduction: We assessed the impact of a personal agency-based training for refugee women and their male partners on their economic and social empowerment, rates of intimate partner violence (IPV), and non-partner violence (NPV). Methods: We conducted an individually randomized controlled trial with 1061 partnered women (aged 18–45) living in a refugee camp in Rwanda. Women received two days of training, and their partners received one day of training. The follow-up survey where all relevant outcomes were assessed was carried out at 6–9 months post-intervention. Results: At follow up, women in the intervention arm were more likely to report partaking in income generating activities (aIRR 1.27 (1.04–1.54), p < 0.05) and skill learning (aIRR 1.59 (1.39–1.82), p < 0.001) and reported a reduction in experience of physical or sexual NPV in the past six months (aIRR 0.65 (0.39–1.07), p < 0.09). While improved, no statistically significant impacts were seen on physical or sexual IPV (aIRR 0.80 (0.58–1.09), p = 0.16), food insecurity (β 0.98 (0.93 to 1.03), p = 0.396), or clean cookstove uptake (aIRR 0.95 (0.88 to 1.01), p = 0.113) in the past six months. We found statistically significant reduction in physical and sexual IPV amongst those experiencing IPV at baseline (aIRR 0.72 (0.50 to 1.02), p < 0.07). Small improvements in self-efficacy scores and our indicator of adapting to stress were seen in the intervention arm. Some challenges were also seen, such as higher prevalence of probable depression and/or anxiety (aIRR 1.79 (1.00-3.22), p = 0.05) and PTSD (aIRR 2.07 (1.10–3.91), p < 0.05) in the intervention arm compared to the control arm. Conclusion: Our findings echo previous research showing personal agency training can support economic well-being of women. We also find potentially promising impacts on gender-based violence. However, there is some evidence that integration of evidence-based mental health support is important when enhancing agency amongst conflict-affected populations. Trial registration number: The trial was registered with ClinicalTrials.gov, Identifier: NCT04081441 on 09/09/2019. Key message: What is known? • There are limited impacts of economic interventions in humanitarian settings on gender-based violence. • Outside of humanitarian settings, agency-based training interventions, both with/or without male partner engagement, have been shown to improve economic impacts, however IPV impacts are not known. • Integrated multi-component interventions that economically empower women and engage male partners hold promise in conflict-affected populations. What are the new findings? • An abbreviated two-day personal agency training for women and one-day training for their male partners led to significant increases in uptake of income generating activities and skill building for women. • Promising trends suggest reduction in non-partner violence for the full study sample and a reduction in intimate partner violence for women who reported IPV at baseline. • Increased rates of probable anxiety and/or depression and post-traumatic stress disorder (PTSD) were identified in the intervention group. What do the new findings imply? • Promising impacts on livelihoods and experience of violence are possible despite the abbreviated nature of this training. • Despite improvements in livelihoods and reduction in experience of violence, more concerted efforts are needed to prevent the increased risk of anxiety, depression, and PTSD found in conflict-affected populations. [ABSTRACT FROM AUTHOR]

Background: This study aimed to explore predictors associated with intermediate (six months) and post-intervention (24 months) increases in daily steps among people with prediabetes or type 2 diabetes participating in a two-year pedometer intervention. Methods: A secondary analysis was conducted based on data from people with prediabetes or type 2 diabetes from two intervention arms of the randomised controlled trial Sophia Step Study. Daily steps were measured with an ActiGraph GT1M accelerometer. Participants were divided into two groups based on their response to the intervention: Group 1) ≥ 500 increase in daily steps or Group 2) a decrease or < 500 increase in daily steps. Data from baseline and from six- and 24-month follow-ups were used for analysis. The response groups were used as outcomes in a multiple logistic regression together with baseline predictors including self-efficacy, social support, health-related variables, intervention group, demographics and steps at baseline. Predictors were included in the regression if they had a p-value < 0.2 from bivariate analyses. Results: In total, 83 participants were included. The mean ± SD age was 65.2 ± 6.8 years and 33% were female. At six months, a lower number of steps at baseline was a significant predictor for increasing ≥ 500 steps per day (OR = 0.82, 95% CI 0.69–0.98). At 24 months, women had 79% lower odds of increasing ≥ 500 steps per day (OR = 0.21, 95% CI 0.05–0.88), compared to men. For every year of increase in age, the odds of increasing ≥ 500 steps per day decreased by 13% (OR = 0.87, 95% CI 0.78–0.97). Also, for every step increase in baseline self-efficacy, measured with the Self-Efficacy for Exercise Scale, the odds of increasing ≥ 500 steps per day increased by 14% (OR = 1.14, 95% CI 1.02–1.27). Conclusions: In the Sophia Step Study pedometer intervention, participants with a lower number of steps at baseline, male gender, lower age or higher baseline self-efficacy were more likely to respond to the intervention with a step increase above 500 steps per day. More knowledge is needed about factors that influence response to pedometer interventions. Trial registration: ClinicalTrials.gov, NCT02374788. [ABSTRACT FROM AUTHOR]

Background: A considerable percentage of flight crew reports to be fatigued regularly. This is partly caused by irregular and long working hours and the crossing of time zones. It has been shown that persistent fatigue can lead to health problems, impaired performance during work, and a decreased work-private life balance. It is hypothesized that an intervention consisting of tailored advice regarding exposure to daylight, optimising sleep, physical activity, and nutrition will lead to a reduction of fatigue in airline pilots compared to a control group, which receives a minimal intervention with standard available information. Methods/design: The study population will consist of pilots of a large airline company. All pilots who posses a smartphone or tablet, and who are not on sick leave for more than four weeks at the moment of recruitment, will be eligible for participation. In a two-armed randomised controlled trial, participants will be allocated to an intervention group that will receive the tailored advice to optimise exposure to daylight, sleep, physical activity and nutrition, and a control group that will receive standard available information. The intervention will be applied using a smartphone application and a website, and will be tailored on flight- and participant-specific characteristics. The primary outcome of the study is perceived fatigue. Secondary outcomes are need for recovery, duration and quality of sleep, dietary and physical activity behaviours, work-private life balance, general health, and sickness absence. A process evaluation will be conducted as well. Outcomes will be measured at baseline and at three and six months after baseline. Discussion: This paper describes the development of an intervention for airline pilots, consisting of tailored advice (on exposure to daylight and sleep-, physical activity, and nutrition) applied into a smartphone application. Further, the paper describes the design of the randomised controlled trial evaluating the effect of the intervention on fatigue, health and sickness absence. If proven effective, the intervention can be applied as a new and practical tool in fatigue management. Results are expected at the end of 2013. Trial registration: Netherlands Trial Register: NTR2722 [ABSTRACT FROM AUTHOR]

Background: Acute respiratory illness (ARI) is the most common cause of acute presentations and hospitalisations of young Indigenous children in Australia and New Zealand (NZ). Environmental tobacco smoke (ETS) from household smoking is a significant and preventable contributor to childhood ARI. This paper describes the protocol for a study which aims to test the efficacy of a family-centred tobacco control program about ETS to improve the respiratory health of Indigenous infants in Australia and New Zealand. For the purpose of this paper 'Indigenous' refers to Australia's Aboriginal and Torres Strait Islander peoples when referring to Australian Indigenous populations. In New Zealand, the term 'Indigenous' refers to Maori. Methods/Design: This study will be a parallel, randomized, controlled trial. Participants will be Indigenous women and their infants, half of whom will be randomly allocated to an 'intervention' group, who will receive the tobacco control program over three home visits in the first three months of the infant's life and half to a control group receiving 'usual care' (i.e. they will not receive the tobacco control program). Indigenous health workers will deliver the intervention, the goal of which is to reduce or eliminate infant exposure to ETS. Data collection will occur at baseline (shortly after birth) and when the infant is four months and one year of age. The primary outcome is a doctor-diagnosed, documented case of respiratory illness in participating infants. Discussion: Interventions aimed at reducing exposure of Indigenous children to ETS have the potential for significant benefits for Indigenous communities. There is currently a dearth of evidence for the effect of tobacco control interventions to reduce children's exposure to ETS among Indigenous populations. This study will provide high-quality evidence of the efficacy of a family-centred tobacco control program on ETS to reduce respiratory illness. Outcomes of our study will be important and significant for Indigenous tobacco control in Australia and New Zealand and prevention of respiratory illness in children. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12609000937213) [ABSTRACT FROM AUTHOR]

Background: Childhood obesity and physical inactivity are increasing dramatically worldwide. Children of low socioeconomic status and/or children of migrant background are especially at risk. In general, the overall effectiveness of school-based programs on health-related outcomes has been disappointing. A special gap exists for younger children and in high risk groups. Methods/Design: This paper describes the rationale, design, curriculum, and evaluation of a multicenter preschool randomized intervention study conducted in areas with a high migrant population in two out of 26 Swiss cantons. Twenty preschool classes in the German (canton St. Gallen) and another 20 in the French (canton Vaud) part of Switzerland were separately selected and randomized to an intervention and a control arm by the use of opaque envelopes. The multidisciplinary lifestyle intervention aimed to increase physical activity and sleep duration, to reinforce healthy nutrition and eating behaviour, and to reduce media use. According to the ecological model, it included children, their parents and the teachers. The regular teachers performed the majority of the intervention and were supported by a local health promoter. The intervention included physical activity lessons, adaptation of the built infrastructure; promotion of regional extracurricular physical activity; playful lessons about nutrition, media use and sleep, funny homework cards and information materials for teachers and parents. It lasted one school year. Baseline and post-intervention evaluations were performed in both arms. Primary outcome measures included BMI and aerobic fitness (20 m shuttle run test). Secondary outcomes included total (skinfolds, bioelectrical impedance) and central (waist circumference) body fat, motor abilities (obstacle course, static and dynamic balance), physical activity and sleep duration (accelerometry and questionnaires), nutritional behaviour and food intake, media use, quality of life and signs of hyperactivity (questionnaires), attention and spatial working memory ability (two validated tests). Researchers were blinded to group allocation. Discussion: The purpose of this paper is to outline the design of a school-based multicenter cluster randomized, controlled trial aiming to reduce body mass index and to increase aerobic fitness in preschool children in culturally different parts of Switzerland with a high migrant population. Trial Registration: Trial Registration: clinicaltrials.gov NCT00674544 [ABSTRACT FROM AUTHOR]

Background: Many teenagers are insufficiently active despite the health benefits of physical activity (PA). There is strong evidence to show that inactivity and low fitness levels increase the risk of non-communicable diseases such as coronary heart disease (CHD), type 2 diabetes and breast and colon cancers (Lee et al. Lancet 380:219-29, 2012). A major barrier facing adolescents is accessibility (e.g. cost and lack of local facilities). The ACTIVE project aims to tackle this barrier through a multi-faceted intervention, giving teenagers vouchers to spend on activities of their choice and empowering young people to improve their fitness and PA levels.Design: ACTIVE is a mixed methods randomised control trial in 7 secondary schools in Swansea, South Wales. Quantitative and qualitative measures including PA (cooper run test (CRT), accelerometery over 7 days), cardiovascular (CV) measures (blood pressure, pulse wave analysis) and focus groups will be undertaken at 4 separate time points (baseline, 6 months,12 months and follow-up at 18 months). Intervention schools will receive a multi-component intervention involving 12 months of £20 vouchers to spend on physical activities of their choice, a peer mentor scheme and opportunities to attend advocacy meetings. Control schools are encouraged to continue usual practice. The primary aim is to examine the effect of the intervention in improving cardiovascular fitness.Discussion: This paper describes the protocol for the ACTIVE randomised control trial, which aims to increase fitness, physical activity and socialisation of teenagers in Swansea, UK via a voucher scheme combined with peer mentoring. Results can contribute to the evidence base on teenage physical activity and, if effective, the intervention has the potential to inform future physical activity interventions and policy.Trial Registration: ISRCTN75594310 (Assigned 06/03/2017). [ABSTRACT FROM AUTHOR]

Background: Despite efforts to eradicate it, open defecation remains widely practiced in India, especially in rural areas. Between 2013 and 2014, 50 villages in one district of Odisha, India, received a sanitation programme under the Nirmal Bharat Abhiyan (NBA - "Clean India Campaign"), the successor of India's Total Sanitation Campaign. This paper documents the strategies and processes of NBA community mobilisation for latrine promotion in these villages and assesses the strengths and limitations of the mobilisation activities.Methods: NBA's community mobilisation activities were observed and assessed against the programme's theory of change in 10 randomly selected programme villages from start to finish. Additional data was collected through review of documents, individual interviews (n = 80) and focus group discussions (n = 26) with staff of the implementing NGOs and community members.Results: Our study revealed the lack of a consistent implementation strategy, lack of capacities and facilitation skills of NGO staff to implement sanitation programmes, political interference, challenges in accessing government financial incentives for latrine construction, and lack of clarity on the roles and responsibilities among government and NGO staff, leading to failure in translating government policies into sustainable actions. Social divisions and village dynamics related to gender and caste further constrained the effectiveness of mobilisation activities. Meetings were often dominated by male members of upper caste households, and excluded low caste community members and views of women. Community discussions revolved largely around the government's cash incentive for latrines. Activities aimed at creating demand for sanitation and use of latrines often resonated poorly with community members. An assessment by the implementers, 1 year after community mobilisation found 19% of households had a completed latrine across the 50 villages, a marginal increase of 7 percentage points over baseline.Conclusions: In this setting, the Government of India's NBA programme to increase rural sanitation coverage and use is hampered by political, programmatic, logistical and socio-structural constraints. Sanitation demand generation was difficult for local implementing NGOs as village populations had lost trust in organisations due to previous indications of fraud. Agencies or organisations implementing sanitation campaigns and conducting sanitation promotions need to enhance their staff's knowledge and build capacity in order to address important social heterogeneity within villages. This trial's registration number is NCT01214785 (October 4, 2010). [ABSTRACT FROM AUTHOR]

Background: Few studies have examined the impact of 'sit less, move more' interventions on workplace performance. This study assessed the short and mid-term impacts of and patterns of change within, a 19-week workplace web-based intervention (Walk@WorkSpain; W@WS; 2010-11) on employees´ presenteeism, mental well-being and lost work performance.Methods: A site randomised control trial recruited employees at six Spanish university campuses (n = 264; 42 ± 10 years; 171 female), assigned by worksite and campus to an Intervention (IG; used W@WS; n = 129; 87 female) or an active Comparison group (A-CG; pedometer, paper diary and self-reported sitting time; n = 135; 84 female). A linear mixed model assessed changes between the baseline, ramping (8 weeks), maintenance (11 weeks) and follow-up (two months) phases for the IG versus A-CG on (i) % of lost work productivity (Work Limitations Questionnaire; WLQ); (ii) three scales for presenteeism (WLQ) assessing difficulty meeting scheduling demands (Time), performing cognitive and inter-personal tasks (Mental-Interpersonal) and decrements in meeting the quantity, quality and timeliness of completed work (Output); and (iii) mental well-being (Warwick-Edinburgh Mental Well-being Scale). T-tests assessed differences between groups for changes on the main outcomes. In the IG, a multivariate logistic regression model identified patterns of response according to baseline socio-demographic variables, physical activity and sitting time.Results: There was a significant 2 (group) × 2 (program time points) interaction for the Time (F [3]=8.69, p = 0.005), Mental-Interpersonal (F [3]=10.01, p = 0.0185), Output scales for presenteeism (F [3]=8.56, p = 0.0357), and for % of lost work performance (F [3]=10.31, p = 0.0161). Presenteeism and lost performance rose significantly in both groups across all study time points; after baseline performance was consistently better in the IG than in the A-CG. Better performance was linked to employees being more active (Time, p = 0.041) and younger (Mental-interpersonal, p = 0.057; Output, p = 0.017). Higher total sitting time during nonworking days (Mental-interpersonal, p = 0.019) and lower sitting time during workdays (WLQ Index, p = 0.013) also improved performance.Conclusion: Versus an active comparison condition, a 'sit less, move more` workplace intervention effectively reduced an array of markers of lost workday productivity.Trial Registration: NCT02960750 ; Date of registration: 07/11/2016. [ABSTRACT FROM AUTHOR]

Background: Common mental disorders (CMDs) are among the leading causes of sick leave in Sweden and other OECD countries. They result in suffering for the individual and considerable financial costs for the employer and for society at large. The occupational health service (OHS) can offer interventions in which both the individual and the work situation are taken into account. The aim of this paper is to describe the design of a study evaluating the effectiveness of an intervention given at the OHS to employees with CMDs or stress-related symptoms at work. In addition, intervention fidelity and its relation to the outcome will be assessed in a process analysis.Methods: The study is designed as a cluster randomized trial in which the participating OHS consultants are randomized into either delivering the intervention or performing care as usual. Employees with CMDs or stress-related symptoms at work are recruited consecutively by the OHS consultants. The intervention aims to improve the match between the employee and the job situation. Interviews are held individually with the employee and the nearest supervisor, after which a joint meeting with both the employee and the supervisor takes place. A participatory approach is applied by which the supervisor and the employee are guided by the OHS consultant and encouraged to actively take part in problem solving concerning the work situation. Outcomes will be assessed at baseline and at six and 12 months. A long-term follow-up at 3 years will also be performed. The primary outcome is registered sickness absence during a 1-year period after study inclusion. Secondary outcomes are mental health and work ability. The intervention's cost effectiveness, compared to treatment as usual, both for society and for the employer will be evaluated. A process evaluation by both the OHS consultants and the employee will be carried out.Discussion: The study includes analyses of the effectiveness of the intervention (clinical and economic) as well as an analysis of its implementation at the participating OHSs. Possible methodological challenges such as selection bias and risk of contamination between OHS consultants delivering the experimental condition and consultants giving usual care are discussed.Trial Registration: ClinicalTrials NCT02563743 Sep 28 2015. [ABSTRACT FROM AUTHOR]

Background: The Fit for School (FIT) programme integrates school health and Water, Sanitation and Hygiene interventions, which are implemented by the Ministries of Education in four Southeast Asian countries. This paper describes the findings of a Health Outcome Study, which aimed to assess the two-year effect of the FIT programme on the parasitological, weight, and oral health status of children attending schools implementing the programme in Cambodia, Indonesia and Lao PDR.Methods: The study was a non-randomized clustered controlled trial with a follow-up period of two years. The intervention group consisted of children attending public elementary schools implementing the FIT programme, including daily group handwashing with soap and toothbrushing with fluoride toothpaste, biannual school-based deworming; as well as construction of group handwashing facilities. Control schools implemented the regular government health education curriculum and biannual deworming. Per school, a random selection of six to seven-year-old grade-one students was drawn. Data on parasitological infections, anthropometric measurements, dental caries, odontogenic infections and sociodemographic characteristics were collected at baseline and at follow-up (24 months later). Data were analysed using the χ2-test, Mann Whitney U-test and multilevel logistic and linear regression.Results: A total of 1847 children (mean age = 6.7 years, range 6.0-8.0 years) participated in the baseline survey. Of these, 1499 children were available for follow-up examination - 478, 486 and 535 children in Cambodia, Indonesia and Lao PDR, respectively. In all three countries, children in intervention schools had a lower increment in the number of decayed, missing and filled permanent teeth between baseline and follow-up, in comparison to children in controls schools. The preventive fraction was 24% at average. The prevalence of soil-transmitted helminth infection (which was unexpectedly low at baseline), the prevalence of thinness and the prevalence of odontogenic infections did not significantly differ between baseline and follow-up, nor between intervention and control schools.Conclusions: The study found that the FIT programme significantly contributed to the prevention of dental caries in children. This study describes the challenges, learnings and, moreover, the importance of conducting real-life implementation research to evaluate health programmes to transform school settings into healthy learning environments for children. The study is retrospectively registered with the German Clinical Trials Register, University of Freiburg (Trial registration number: DRKS00004485, date of registration: 26th of February, 2013). [ABSTRACT FROM AUTHOR]

Background: We have developed a healthy lifestyles programme (HeLP) for primary school aged children (9-10 years), currently being evaluated in a definitive cluster randomised controlled trial. This paper descriptively presents the baseline characteristics of trial children (BMI, waist circumference, % body fat, diet and physical activity) by gender, cluster level socio-economic status, school size and time of recruitment into the trial.Methods: Schools were recruited from across the South West of England and allocated 1:1 to either intervention (HeLP) or control (usual practice) stratified by the proportion of children eligible for free school meals (FSM, <19%, ≥19%) and school size (one Year 5 class, >1 Year 5 class). The primary outcome is change in body mass index standard deviation score (BMI sds) at 24 months post-randomisation. Secondary outcomes are BMI sds at 18 months, waist circumference and percentage body fat sds at 18 and 24 months, proportion of children classified as underweight, overweight and obese at 18 and 24 months, physical activity (for a sub-sample) and food intake at 18 months.Results: At baseline 11.4% and 13.6% of children were categorised as overweight or obese respectively. A higher percentage of girls than boys (25.3% vs 24.8%) and children from schools in FSM category 2 (28.2% vs 23.2%) were overweight or obese. Children were consuming a mean (range) of 4.15 (0-13) energy dense snacks (EDS) and 3.23 (0-9) healthy snacks (HS) per day with children from schools in FSM category 2 consuming more EDS and negative food markers and less HS and positive food markers. Children spent an average 53.6 min per day (11.9 to 124.8) in MVPA and thirteen hours (779.3 min) per day (11 h to 15 h) doing less than 'light' intensity activity. Less than 5% of children achieved the Departments of Health's recommendation of 60 min of MVPA every day.Conclusion: We have excellent completeness of baseline data for all measures and have achieved compliance to accelerometry not seen before in other large scale studies. Our anthropometric baseline data is representative of local and national data for children this age and reflects the gender and socio-economic variations expected of children this age in relation to physical activity and weight status.Trial Registration: ISRCTN15811706 (1/05/2012). [ABSTRACT FROM AUTHOR]

Background: Around a fifth of children starting school in England are now overweight/obese. There is a paucity of interventions with the aim of obesity prevention in preschool-age children in the UK. Previous research has demonstrated some positive results in changing specific health behaviours, however, positive trends in overall obesity rates are lacking. Preschool settings may provide valuable opportunities to access children and their families not only for promoting healthy lifestyles, but also to develop and evaluate behaviour-change interventions.Methods: This paper presents a cluster randomised feasibility study of a theory based behaviour-change preschool practitioner-led intervention tested in four preschool centres in the North East of England. The primary outcome measures were to test the acceptability and feasibility of the data collection measures and intervention. Secondary measures were collected and reported for extra information. At baseline and post intervention, children's anthropometric, dietary and physical activity measures as well as family 'active' time data were collected. The preschool practitioner-led intervention included family intervention tasks such as 'family goal-setting activities' and 'cooking challenges'. Preschool activities included increasing physical activity and providing activities with the potential to change behaviour with increased knowledge of and acceptance of healthy eating. The process evaluation was an on-going monthly process and was collected in multiple forms such as questionnaires, photographs and verbal feedback.Results: 'Gatekeeper' permission and lower-hierarchal adherence were initially a problem for recruitment and methods acceptance. However, at intervention end the preschool teachers and parents stated they found most intervention methods and activities acceptable, and some positive changes in family health behaviours were reported. However, the preschool centres appeared to have difficulties with enforcing everyday school healthy eating policies.Conclusions: The findings from the current study may have implications for nursery practitioners, nursery settings, Local Educational Authorities and policy makers, and contributes to the body of literature. However, further work with preschool practitioners is required to determine how personal attitudes and school policy application can be supported to implement successfully such an intervention.Trial Registration: ISRCTN12345678 (16/02/17) retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Mothers In Motion (MIM), a community-based lifestyle behavioral intervention, was designed and conducted to help low-income overweight and obese young mothers prevent further weight gain via promotion of stress management, healthy eating, and physical activity. This paper presents intervention effect on body weight (primary outcome) and summarizes lessons learned.Methods: Participants (N = 612) were recruited from 7 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) offices in Michigan and were individually randomized to an intervention n= 410) or a comparison (n =202) group (2: 1 ratio). During the 16-week intervention, intervention participants watched theory-based culturally sensitive videos (in DVD format) featuring peers from the target audience to learn skills for managing stress, eating healthier, and being more physically active. They also dialed into peer support group teleconferences to enhance skills learned in the videos and increase motivation for lifestyle behavioral changes. Body weight, the primary outcome, was measured at baseline, immediately after the 16-week intervention, and 3 months after the 16-week intervention. Intervention effect was tested via general linear mixed model for repeated measures, using baseline measures as adjusting covariates.Results: At baseline, the mean age of the participants was 28.5 ± 5.0 years (intervention: 28.4 ± 5.0, comparison: 28.9 ± 5.0); the mean body weight was 190.2 ± 1.4 lbs (intervention: 191.8 ± 30.0, comparison: 188.5 ± 29.1); and the mean body mass index (BMI) was 32.2 ± 4.4 (intervention: 32.2 ± 4.4, comparison: 31.7 ± 4.2). Of sample, 64.7% were obese. At 3 months after the 16-week intervention, no significant weight differences were found between the intervention (188.3 ± 10.6 lbs, BMI: 31.6 ± 1.8) and comparison groups (187.7 ± 10.6 lbs, BMI: 31.53 ± 1.8) when controlling for baseline body weight.Conclusions: This lifestyle behavioral intervention that focused on stress management, healthy eating and physical activity was not effective in helping low-income overweight and obese young mothers prevent further weight gain.Trial Registration: Clinical Trials NCT01839708 . This trial was registered retrospectively on February 28, 2013. [ABSTRACT FROM AUTHOR]

Background: Obesity and other nutrition-related chronic disease rates are high in American Indian (AI) populations, and an urgent need exists to identify evidence-based strategies for prevention and treatment. Multi-level, multi-component (MLMC) interventions are needed, but there are significant knowledge gaps on how to deliver these types of interventions in low-income rural AI communities.Methods: OPREVENT2 is a MLMC intervention targeting AI adults living in six rural reservations in New Mexico and Wisconsin. Aiming to prevent and reduce obesity in adults by working at multiple levels of the food and physical activity (PA) environments, OPREVENT2 focuses on evidence-based strategies known to increase access to, demand for, and consumption of healthier foods and beverages, and increase worksite and home-based opportunities for PA. OPREVENT2 works to create systems-level change by partnering with tribal stakeholders, multiple levels of the food and PA environment (food stores, worksites, schools), and the social environment (children as change agents, families, social media). Extensive evaluation will be conducted at each level of the intervention to assess effectiveness via process and impact measures.Discussion: Novel aspects of OPREVENT2 include: active engagement with stakeholders at many levels (policy, institutional, and at multiple levels of the food and PA system); use of community-based strategies to engage policymakers and other key stakeholders (community workshops, action committees); emphasis on both the built environment (intervening with retail food sources) and the social environment. This paper describes the design of the intervention and the evaluation plan of the OPREVENT2.Trial Registration: Clinical Trial Registration: NCT02803853 (June 10, 2016). [ABSTRACT FROM AUTHOR]

Background: The worksite cafeteria is a suitable setting for interventions focusing on changing eating behavior, because a lot of employees visit the worksite cafeteria regularly and a variety of interventions could be implemented there. The aim of this paper is to describe the intervention development and design of the evaluation of an intervention to make the purchase behavior of employees in the worksite cafeteria healthier. The developed intervention called "the worksite cafeteria 2.0" consists of a set of 19 strategies based on theory of nudging and social marketing (marketing mix). The intervention will be evaluated in a real-life setting, that is Dutch worksite cafeterias of different companies and with a number of contract catering organizations.Methods/design: The study is a randomized controlled trial (RCT), with 34 Dutch worksite cafeterias randomly allocated to the 12-week intervention or to the control group. Primary outcomes are sales data of selected products groups like sandwiches, salads, snacks and bread topping. Secondary outcomes are satisfaction of employees with the cafeteria and vitality.Discussion: When executed, the described RCT will provide better knowledge in the effect of the intervention "the worksite cafeteria 2.0" on the purchasing behavior of Dutch employees in worksite cafeterias.Trial Registration: Dutch Trial register: NTR5372 . [ABSTRACT FROM AUTHOR]

Background: Early identification of persons at risk of sickness absence due to work-related stress is a crucial problem for society in general, and primary health care in particular. Tho date, no established method to do this exists. This project's aim is to evaluate whether systematic early identification of work-related stress can prevent sickness absence. This paper presents the study design, procedure and outcome measurements, as well as allocation and baseline characteristics of the study population. Method/design: The study is a two-armed randomized controlled trial with follow-up at 3, 6 and 12 months. Non-sick-listed employed women and men, aged 18 to 64 years, who had mental and physical health complaints and sought care at primary health care centers (PHCC) were eligible to participate. At baseline work-related stress was measured by the Work Stress Questionnaire (WSQ), combined with feedback at consultation, at PHCC. The preventive intervention included early identification of work-related stress by the WSQ, GP training in the use of WSQ, GP feedback at consultation and finding suitable preventive measures. A process evaluation was used to explore how to facilitate future implementation and structural use of the WSQ at the PHCC. The primary outcome to compare the preventive sick leave intervention by the general practitioner (GP) versus treatment as usual is sick leave data obtained from the Swedish Social Insurance Agency register. Discussion: Early screening for sick leave due to work-related stress makes it possible not only to identify those at risk for sick leave, but also to put focus on the patient's specific work-related stress problems, which can be helpful in finding suitable preventive measures. This study investigates if use of the WSQ by GPs at PHCCs, combined with feedback at consultation, prevents future sickness absence. [ABSTRACT FROM AUTHOR]

Background: Several RCT studies have aimed to reduce either musculoskeletal disorders, sickness presenteeism, sickness absenteeism or a combination of these among females with high physical work demands. These studies have provided evidence that workplace health promotion (WHP) interventions are effective, but long-term effects are still uncertain. These studies either lack to succeed in maintaining intervention effects or lack to document if effects are maintained past a one-year period. This paper describes the background, design and conceptual model of the FRIDOM (FRamed Intervention to Decrease Occupational Muscle pain) WHP program among health care workers. A job group characterized by having high physical work demands, musculoskeletal disorders, high sickness presenteeism - and absenteeism. Methods: FRIDOM aimed to reduce neck and shoulder pain. Secondary aims were to decrease sickness presenteeism, sickness absenteeism and lifestyle-diseases such as other musculoskeletal disorders as well as metabolic-, and cardiovascular disorders - and to maintain participation to regular physical exercise training, after a one year intervention period. The entire concept was tailored to a population of female health care workers. This was done through a multi-component intervention including 1) intelligent physical exercise training (IPET), dietary advice and weight loss (DAW) and cognitive behavioural training (CBT). Discussion: The FRIDOM program has the potential to provide evidence-based knowledge of the pain reducing effect of a multi component WHP among a female group of employees with a high prevalence of musculoskeletal disorders and in a long term perspective evaluate the effects on sickness presenteeism and absenteeism as well as risk of life-style diseases. [ABSTRACT FROM AUTHOR]

Background: Peer-led lifestyle interventions have gained recognition as effective approaches for managing and preventing chronic diseases. However, there remains a critical knowledge gap regarding the impact and effectiveness of peer-led interventions specifically in the primary prevention of cardiovascular disease (CVD). Our systematic review aims to synthesise the available evidence and evaluate the impact of peer-led lifestyle interventions, providing invaluable insights that can guide the development of peer-led strategies for preventing CVD. Methods: Systematic database searches were conducted on Ovid Medline, Embase, Cochrane Centre for Controlled Trials, PubMed and Scopus to source peer-reviewed articles published between 2013 and 2023. Reference lists of the included publications were also manually searched. Results: Fourteen unique randomised controlled trials were identified, of which three were pilot studies. Most of the interventions were conducted among individuals at moderate to high risk of CVD and lasted for a year. There is a variety of components in intervention delivery, including group discussions and individual counselling. Peer leader training mostly covered intervention delivery, communication, and research-specific skills. Systolic blood pressure showed the most promising CVD-related improvement, while mixed results were found for several other dietary and lifestyle behavioural outcomes. Conclusion: Peer-led lifestyle interventions have shown varying effectiveness in cardiovascular health outcomes. The competencies and roles of peer leaders were identified to guide future intervention development with a more comprehensive approach to the primary prevention of CVD. [ABSTRACT FROM AUTHOR]

Background: Women who are sexually active are at risk of sexually transmitted infections (STIs), which can cause serious difficulties for their reproductive health. However, despite the high global burden of STIs, most infections are preventable with education for behavioral change. The purpose of this study is to investigate the Efficacy of Mobile-Based Educational Intervention Using Instructional Systems Design in Promoting Preventive Behaviors for Sexually Transmitted Infections among Iranian Women. Methods: This randomized controlled trial aimed at promoting preventive behaviors related to STIs in Iranian women with an educational intervention based on the Instructional Systems Design (ISD) in 2022. The participants in this study were recruited from a single center, specifically the Health House No. 3 located in District 11 of Tehran Municipality. Two instruments were used in the present study: a) a valid scale titled: "Four-Scale of STI Preventive Behaviors", and b) a researcher-made Questionnaire titled: "Social perception affecting sexually transmitted infections (SOPESTI)". These tools contain 8 demographic items and specific questions with a total of 68 five-point Likert scales. The intervention comprised three phases: a pre-test (baseline), a training program, and two follow-up assessments (4 and 12 weeks after the start of the training program). The experimental group received education through a mobile app, while the control group received no intervention. SPSS v.26 was used, with a significance level of P < 0.05. The chi-square test, Fisher's exact test, independent t-tests, analysis of covariance (ANCOVA), and repeated measures ANOVA were used to analyze the data. Results: A total of 80 women, with a mean age of 36.524 ± 6.91 (experiment group) and 34.78 ± 8.20 (control group), respectively, participated in the trial. The study revealed a statistically significant difference in the mean score for eight domains, including STIs Knowledge, STIs Vulnerability, STIs Preventive Self-efficacy, STIs Prevention intentions, STIs Perceived social exclusion, STIs Perceived cognitive barriers, STIs Perceived social support, and STIs Perceived risks in the experiment group following the intervention compared to before the intervention (p < 0.05). Conclusion: The results of this study showed that a mobile-based educational intervention based on the ISD model had a significant effect on the preventive behaviors of STIs in Iranian women. These results highlight the potential benefit of mobile health in enhancing reproductive health. Trial registration: ClinicalTrials.gov IRCT20200602047638N1. Registered on 22 May 2021 with the IRCTID, V1.0. https://www.irct.ir/trial/55632 [ABSTRACT FROM AUTHOR]

Background: Several systematic reviews have been published to investigate the effectiveness of high-intensity interval training (HIIT) in schools. However, there has been limited attention given to understanding the functioning of the intervention processes, which is of paramount importance for interpreting and translating the intervention effectiveness. The aim of this systematic review is to determine the extent to which process evaluation is measured in school-based HIIT interventions and to explore the effects of process evaluation and intervention characteristics on cardiorespiratory fitness (CRF), body composition, muscular strength, and blood pressure. Methods: A comprehensive search was conducted in SPORT Discus (EBSCOhost), Web of Science, Scopus, Medline (Ovid) and Cochrane Central Register of Controlled Trials. The extent to which process evaluation is measured was narratively reported, alongside with the guidance of process evaluation of complex interventions by UK Medical Research Council. Meta-analyses and meta-regressions were conducted to determine the effects of process evaluation and intervention characteristics to the intervention outcomes. Results: The literature search identified 77 studies reporting on 45 school-based HIIT interventions. In total, five interventions reported process evaluation in a section or in a separate study, and only one intervention adopted a process evaluation framework. On average, 6 out of 12 process evaluation measures were reported in all interventions. Subgroup analyses did not indicate any beneficial treatment effects for studies with process evaluation group, whereas all pooled data and studies without process evaluation group showed significant improvement for CRF and body composition. Conclusion: Process evaluation is frequently omitted in the literature of school-based HIIT in children and adolescents. Although reporting of process evaluation measures may not directly associate with better intervention outcomes, it allows accurate interpretation of intervention outcomes, thereby enhancing the generalisability and dissemination of the interventions. [ABSTRACT FROM AUTHOR]