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Background: Given the ongoing childhood obesity public health crisis and potential protective effect of family meals, there is need for additional family meals research, specifically experimental studies with expanded health outcomes that focus on the at-risk populations in highest need of intervention. Future research, specifically intervention work, would also benefit from an expansion of the target age range to include younger children, who are laying the foundation of their eating patterns and capable of participating in family meal preparations. The purpose of this paper is to address this research gap by presenting the objectives and research methods of a 10-week multi-component family meals intervention study aimed at eliciting positive changes in child diet and weight status.Methods: This will be a group quasi-experimental trial with staggered cohort design. Data will be collected via direct measure and questionnaires at baseline, intervention completion (or waiting period for controls), and 10-weeks post-intervention. Setting will be faith-based community center. Participants will be 60 underserved families with at least 1, 4-10 year old child will be recruited and enrolled in the intervention (n = 30) or waitlist control group (n = 30). The intervention (Simple Suppers) is a 10-week family meals program designed for underserved families from racial/ethnic diverse backgrounds. The 10, 90-min program lessons will be delivered weekly over the dinner hour. Session components include: a) interactive group discussion of strategies to overcome family meal barriers, plus weekly goal setting for caregivers; b) engagement in age-appropriate food preparation activities for children; and c) group family meal for caregivers and children. Main outcome measures are change in: child diet quality; child standardized body mass index; and frequency of family meals. Regression models will be used to compare response variables results of intervention to control group, controlling for confounders. Analyses will account for clustering by family and cohort. Significance will be set at p < 0.05.Discussion: This is the first experimentally designed family meals intervention that targets underserved families with elementary school age children and includes an examination of health outcomes beyond weight status. Results will provide researchers and practitioners with insight on evidence-based programming to aid in childhood obesity prevention.Trial Registration: NCT02923050 . Registered 03 October 2016. Retrospectively registered. [ABSTRACT FROM AUTHOR]

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

Background Overweight and obese children are likely to develop serious health problems. Among children in the U.S., Latino children are affected disproportionally by the obesity epidemic. Niños Sanos, Familia Sana (Healthy Children, Healthy Family) is a five-year, multi-faceted intervention study to decrease the rate of BMI growth in Mexican origin children in California's Central Valley. This paper describes the methodology applied to develop and launch the study. Methods/Design Investigators use a community-based participatory research approach to develop a quasi- experimental intervention consisting of four main components including nutrition, physical activity, economic and art-community engagement. Each component's definition, method of delivery, data collection and evaluation are described. Strategies to maintain engagement of the comparison community are reported as well. Discussion We present a study methodology for an obesity prevention intervention in communities with unique environmental conditions due to rural and isolated location, limited infrastructure capacity and limited resources. This combined with numerous cultural considerations and an unstable population with limited exposure to researcher expectations necessitates reassessment and adaptation of recruitment strategies, intervention delivery and data collection methods. [ABSTRACT FROM AUTHOR]

Background: Childhood obesity rates more than double during primary school in England. Acquiring competent cooking skills is a key part of children's education that can lead to improved knowledge of a healthy lifestyle and dietary behaviours. Evaluation of the impact of 'PhunkyFoods', a school-based food and nutrition education programme, will assess food literacy, cooking skills and dietary behaviour in primary-school children.Methods: A cluster randomised controlled trial will be undertaken in 28 primary schools in North Yorkshire, UK, including a total population of children aged 7-9 years (n = 420). The trial has two arms: (a) the intervention group receiving PhunkyFoods programme (n = 210) and (b) the wait-list control group receiving the usual school curriculum (n = 210). The intervention 'PhunkyFoods' will be delivered by Purely Nutrition Ltd. The participating school staff are supported with training, policy development and access to resources to improve the delivery of nutrition education. Children participate through whole school assemblies, classroom activities, and after-school clubs about food preparation, cooking healthy meals and healthy living. Schools, parents and children have access to healthy meal recipes through the PhunkyFoods website. The primary outcomes are differences in food literacy and cooking skills scores between control and intervention arms after 12 months of the intervention and adjusted for baseline values. The secondary outcome is differences in fruit and vegetable intake between the arms after 12 months (adjusted for baseline). Treatment effects will be examined using mixed ANOVA and regression analysis. Primary analyses will adjust for baseline food literacy and cooking skills scores and secondary analysis will adjust for pre-specified baseline school and child level covariates.Discussion: The PhunkyFoods programme is a flexible menu of options for schools to choose from, making this a highly complex intervention. Following Medical Research Council guidance, research perspectives will focus on effectiveness and theory-based approaches: to what extent the intervention produces the intended outcomes in real-world settings and what works in which circumstances.Trial Registration: ISRCTN ISRCTN68114155 . Prospectively registered on 22 October 2021. [ABSTRACT FROM AUTHOR]

Background: Whole-of-community interventions hold promise in addressing childhood obesity. The COMPACT Stakeholder-driven Community Diffusion theory posits that stakeholders' knowledge of childhood obesity prevention efforts and engagement with the issue contribute to successful intervention implementation. Building on completed formative research and pilot testing, we describe the validation and refinement of knowledge and engagement measures.Methods: We assessed content validity using a modified Delphi process with science (n=18) and practice-based (n=16) experts. Next, we refined the survey based on input from science- and practice-based experts, cognitive response testing, and item analysis of extant survey data. Field testing of the refined survey involved community stakeholders in Greenville County, South Carolina (n=50), East Boston, Massachusetts (n=30), and Tucson, Arizona (n=84) between 2019 and 2020. Construct validity was assessed with confirmatory factor analysis (CFA). Two-week test-retest reliability was assessed among a subsample of 14 paired respondents in South Carolina.Results: Experts rated existing knowledge domains (intervention factors, roles, sustainability, problem, resources) and engagement domains (dialogue/mutual learning, flexibility, influence/power, leadership/stewardship, trust) highly for their importance in addressing childhood obesity. Expert input resulted in 11 new knowledge items and 7 new engagement items that mapped onto existing domains. Correspondingly, two domain names were modified: implementation/sustainability and trust/trustworthiness. We also eliminated 8 extant items (4 knowledge and 4 engagement) and adapted item language for comprehension and consistency. Further modifications based on CFA results and item analyses resulted in 23 knowledge items across four domains (roles and resources merged) and 23 engagement items across five domains. Modified knowledge and engagement scales had adequate fit and strong item factor loadings (most >0.7 and all >0.5). Knowledge (α=0.86-0.87) and engagement (α=0.75-0.90) subscales had high internal scale consistency. Knowledge intraclass correlation coefficients (ICCs) for test-retest agreement of subscale scores ranged from 0.50 for intervention factors to 0.86 for roles/resources. For engagement subscale scores, ICCs ranged from 0.70 for trust/trustworthiness to 0.96 for leadership/stewardship.Conclusions: Findings from this multi-method survey development process increase our confidence of the knowledge and engagement measures' content validity, construct validity, and reliability. [ABSTRACT FROM AUTHOR]

Background: Increasingly, public health interventions are delivered via telephone and/or text messages. Recent systematic reviews of early childhood obesity prevention interventions have not adequately reported on the way interventions are delivered and the experiences/perceptions of stakeholders. We aimed to summarise the literature in early childhood obesity prevention interventions delivered via telephone or text messages for evidence of application of process evaluation primarily to evaluate stakeholders' acceptability of interventions. Methods: A systematic search of major electronic databases was carried out using the Population, Intervention, Comparison, Outcomes framework. Studies were included if interventions were delivered via telephone/text messages; aimed at changing caregivers' behaviours to prevent early childhood obesity; with one or more outcomes related to early obesity risk factors such as breastfeeding, solid feeding, tummy time, sleep and settling, physical activity and screen time; published from inception to May 2020. All eligible studies were independently assessed by two reviewers using the Cochrane Collaboration tool for assessing risk of bias. Qualitative studies were assessed using the Consolidated Criteria for Reporting Qualitative Research and Standards for Reporting Qualitative Research tools. Results: Twenty-four studies were eligible, and the overall risk of bias was low. Eight studies (33%) had evidence of process evaluation that examined participants' perceptions of interventions. Participants appreciated the convenience of receiving interventions via telephone or text messages. 63% of all studies in this review showed improvement in one or more behaviours related to childhood obesity prevention. Participants were likely to modify behaviours if they received information from a credible source such as from health professionals. Conclusion: There is limited reporting of stakeholders' experiences in early obesity prevention studies delivered by telephone or text messages. Only one-third of studies examined participants' acceptability and the potential for delivery of childhood obesity prevention interventions conveniently using this mode of delivery. Interventions delivered remotely via telephone or text messages have the potential to reach equal or a greater number of participants than those delivered via face-to-face methods. Future research should build in process evaluation alongside effectiveness measurements to provide important insight into intervention reach, acceptability and to inform scale up. Trial registration: PROSPERO registration: CRD42019108658 [ABSTRACT FROM AUTHOR]

Background: Childhood obesity prevention is a public health priority. Children spend a large proportion of their waking time in school; therefore this is an appropriate setting to implement obesity prevention initiatives. Anecdotal reports suggest that implementing The Daily Mile in schools has had positive effects on childhood obesity, academic attainment and wellbeing. This trial aims to measure the effectiveness of The Daily Mile for improving health and wellbeing.Methods: This protocol describes a cluster randomised controlled trial (RCT) in 40 primary schools located in Birmingham, UK. Eligible participants are children in years 3 (aged 7-8) and 5 (aged 9-10). The study compares The Daily Mile (intervention) to usual practice (control) in relation to health and wellbeing. The Daily Mile intervention involves an additional 15 min of running or walking integrated into the school day, throughout a 12 month study period. The primary clinical outcome is body mass index (BMI) z-scores at 12 months following introduction of the intervention. The cost per Quality Adjusted Life Year (QALY) is the primary outcome of the economic evaluation. Secondary outcomes include wellbeing, physical fitness and teacher reported academic attainment.Discussion: This study is the first RCT investigating the clinical and cost-effectiveness of The Daily Mile. A range of outcomes will be measured to evaluate the broader wellbeing and academic benefits in addition to clinical outcomes typically measured in childhood obesity prevention trials. The intervention is simple and low-cost, therefore if the benefits are demonstrated it has enormous potential to influence future policy.Trial Registration: ISRCTN: 12698269 . Date protocol registered 27th October 2016. [ABSTRACT FROM AUTHOR]

Background: The development of healthy food portion sizes among families is deemed critical to childhood weight management; yet little is known about the interacting factors influencing parents' portion control behaviours. This study aimed to use two synergistic theoretical models of behaviour: the COM-B model (Capability, Opportunity, Motivation - Behaviour) and Theoretical Domains Framework (TDF) to identify a broad spectrum of theoretically derived influences on parents' portion control behaviours including examination of affective and habitual influences often excluded from prevailing theories of behaviour change.Methods: Six focus groups exploring family weight management comprised of one with caseworkers (n = 4), four with parents of overweight children (n = 14) and one with parents of healthy weight children (n = 8). A thematic analysis was performed across the dataset where the TDF/COM-B were used as coding frameworks.Results: To achieve the target behaviour, the behavioural analysis revealed the need for eliciting change in all three COM-B domains and nine associated TDF domains. Findings suggest parents' internal processes such as their emotional responses, habits and beliefs, along with social influences from partners and grandparents, and environmental influences relating to items such as household objects, interact to influence portion size behaviours within the home environment.Conclusion: This is the first study underpinned by COM-B/TDF frameworks applied to childhood weight management and provides new targets for intervention development and the opportunity for future research to explore the mediating and moderating effects of these variables on one another. [ABSTRACT FROM AUTHOR]

Background: There is some evidence that school-based interventions are effective in preventing childhood obesity. However, longer term outcomes, equity of effects and cost-effectiveness of interventions have not been assessed. The aim of this trial is to assess the clinical and cost-effectiveness of a multi-component intervention programme targeting the school and family environment through primary schools, in preventing obesity in 6-7 year old children, compared to usual practice. Methods: This cluster randomised controlled trial is set in 54 primary schools within the West Midlands, UK, including a multi-ethnic, socioeconomically diverse population of children aged 6-7 years. The 12-month intervention consists of healthy diet and physical activity promotion. These include: activities to increase time spent doing physical activity within the school day, participation in the 'Villa Vitality' programme (a programme that is delivered by an iconic sporting institution (Aston Villa Football Club), which provides interactive learning opportunities for physical activity and healthy eating), healthy cooking skills workshops in school time for parents and children, and provision of information to families signposting local leisure opportunities. The primary (clinical) outcome is the difference in body mass index (BMI) z-scores between arms at 3 and 18 months post-intervention completion. Cost per Quality Adjusted Life Year (QALY) will also be assessed. The sample size estimate (1000 children split across 50 schools at follow-up) is based on 90% power to detect differences in BMI z-score of 0.25 (estimated ICC ≤ 0.04), assuming a correlation between baseline and follow-up BMI z-score of 0.9. Treatment effects will be examined using mixed model ANCOVA. Primary analysis will adjust for baseline BMI z-score, and secondary analysis will adjust for pre-specified baseline school and child level covariates. Discussion: The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study is the first trial that will examine the cost-effectiveness and long term outcomes of a childhood obesity prevention programme in a multiethnic population, with a sufficient sample size to detect clinically important differences in adiposity. The intervention was developed using the Medical Research Council framework for complex interventions, and outcomes are measured objectively, together with a comprehensive process evaluation. [ABSTRACT FROM AUTHOR]

Background: Although the mandate of recreational facilities is to enhance well-being, many offer foods inconsistent with recommendations for healthy eating. Little is known regarding recreational facility food environments and how they might be improved, as few studies exist. The Alberta Nutrition Guidelines for Children and Youth (ANGCY) are intended to ensure access to healthy food choices in schools, childcare and recreational facilities. This study investigated awareness, adoption and implementation of the ANGCY among recreational facilities in Alberta, Canada, one year following their release. Methods: A cross-sectional telephone survey was conducted from June - December, 2009 (n = 151) with managers of publicly funded recreational facilities that served food. The questionnaire included 10 closed and 7 open ended questions to assess the organizational priority for healthy eating, awareness, adoption and implementation of the ANGCY. Chi-squared tests examined quantitative variables, while qualitative data were analysed using directed content analysis. Greenhalgh's model of diffusion of complex innovations within health service organizations constituted the theoretical framework for the study. Results: One half of respondents had heard of the ANGCY, however their knowledge of them was limited. Although 51% of facilities had made changes to improve the nutritional quality of foods offered in the past year, only a small fraction (11%) of these changes were motivated by the ANGCY. At the time of the survey, 14% of facilities had adopted the ANGCY and 6% had implemented them. Barriers to adoption and implementation were primarily related to perceived negative attributes of the ANGCY, the inner (organizational) context, and negative feedback received during the implementation process. Managers strongly perceived that implementing nutrition guidelines would limit their profit-making ability. Conclusions: If fully adopted and implemented, the ANGCY have the potential to make a significant and sustained contribution to improving the recreational facility food environment, however one year following their release, awareness, adoption and implementation of the ANGCY remained low. A mandated policy approach could offer an efficacious, cost-effective means of improving the food environment within recreational facilities. [ABSTRACT FROM AUTHOR]