The impact of active stakeholder involvement on recruitment, retention and engagement of schools, children and their families in the cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP): a school-based intervention to prevent obesity

Lloyd, Jenny; McHugh, Camilla; Minton, Jayne A.L.; Eke, Helen Nneka; Wyatt, Katrina

doi:10.1186/s13063-017-2122-1

Cited by 17 publications

(30 citation statements)

References 32 publications

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“…We attribute this to the extensive stakeholder involvement in the intervention development, trial design and delivery, and building of trusting and supportive relationships with schools, children, and families. 20 , 29 …”

Section: Discussionmentioning

confidence: 99%

Effectiveness of the Healthy Lifestyles Programme (HeLP) to prevent obesity in UK primary-school children: a cluster randomised controlled trial

Lloyd

Creanor

Logan

et al. 2018

The Lancet Child & Adolescent Health

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SummaryBackgroundAlthough childhood overweight and obesity prevalence has increased substantially worldwide in the past three decades, scarce evidence exists for effective preventive strategies. We aimed to establish whether a school-based intervention for children aged 9–10 years would prevent excessive weight gain after 24 months.MethodsThis pragmatic cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a school-based obesity prevention intervention, was done in 32 schools in southwest England. All state-run primary and junior schools in Devon and Plymouth (UK) with enough pupils for at least one year-5 class were eligible. Schools were assigned (1:1) using a computer-generated sequence to either intervention or control, stratified by the number of year-5 classes (one vs more than one) and the proportion of children eligible for free school meals (<19% [the national average] vs ≥19%). HeLP was delivered to year-5 children (ages 9–10 years) over 1 year, and included dynamic and interactive activities such as physical activity workshops, education sessions delivered by teachers with short homework tasks, drama sessions, and setting goals to modify behaviour (with parental support and one-to-one discussions with HeLP coordinators). The primary outcome was change in body-mass index (BMI) standard deviation score (SDS) between baseline and 24 months, analysed in children with BMI data available for both timepoints. This study is registered with the International Standard Randomised Controlled Trial register, number ISRCTN15811706, and the trial status is complete.FindingsBetween March 21, 2012, and Sept 30, 2013, 32 eligible schools with 1324 children were recruited, of which 16 schools (676 children) were randomly assigned to the HeLP intervention and 16 schools (648 children) to control. All schools that began the trial completed the intervention, and 1244 children (628 in intervention group and 616 in control group) had BMI data at both baseline and 24 months for the primary outcome analysis. Mean BMI SDS was 0·32 (SD 1·16) at baseline and 0·35 (1·25) at 24 months in the intervention group, and 0·18 (1·14) at baseline and 0·22 (1·22) at 24 months in the control group. With adjustment for school-level clustering, baseline BMI scores, sex, cohort, and number of year-5 classes and socioeconomic status of each school, the mean difference in BMI SDS score (intervention–control) at 24 months was −0·02 (95% CI −0·09 to 0·05), p=0·57. One parent reported an adverse event related to their child's eating and activity behaviours, but agreed for the child to continue trial participation after discussion with the chief investigator.InterpretationDespite a theoretically informed and extensively piloted intervention that achieved high levels of engagement, follow-up, and fidelity of delivery, we found no effect of the intervention on preventing overweight or obesity. Although schools are an ideal setting in which to deliver population-based interventions, school-based interventions might not be suffic...

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Section: Discussionmentioning

confidence: 99%

Effectiveness of the Healthy Lifestyles Programme (HeLP) to prevent obesity in UK primary-school children: a cluster randomised controlled trial

Lloyd

Creanor

Logan

et al. 2018

The Lancet Child & Adolescent Health

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“…However, the definitive trial involved 32 schools and an eight-fold increase in intervention delivery. Continuing involvement from our stakeholder group regarding intervention delivery [ 32 ], consideration of delivery qualities and characteristics of personnel [ 20 ], training and manualising delivery for every component based on extensive piloting [ 22 , 33 ] supported the high degree of intervention fidelity across all schools and by all four HeLP Coordinators.…”

Section: Discussionmentioning

confidence: 99%

Intervention fidelity in the definitive cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP) trial: findings from the process evaluation

Lloyd

Dean

Creanor

et al. 2017

Int J Behav Nutr Phys Act

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BackgroundThe Healthy Lifestyles Programme (HeLP) was a novel school-located intervention for 9–10 year olds, designed to prevent obesity by changing patterns of child behaviour through the creation of supportive school and home environments using dynamic and creative delivery methods. This paper reports on both the quantitative and qualitative data regarding the implementation of the HeLP intervention in the definitive cluster randomised controlled trial, which was part of the wider process evaluation.MethodsMixed methods were used to collect data on intervention uptake, fidelity of delivery in terms of content and quality of delivery of the intervention, as well as school and child engagement with the programme. Data were collected using registers of attendance, observations and checklists, field notes, focus groups with children and semi-structured interviews with teachers. Qualitative data were analysed thematically and quantitative data were summarized using descriptive statistics.ResultsAll 16 intervention schools received a complete or near complete programme (94–100%), which was delivered in the spirit in which it had been designed. Of the 676 children in the intervention schools, over 90% of children participated in each phase of HeLP; 92% of children across the socio-economic spectrum were deemed to be engaged with HeLP and qualitative data revealed a high level of enjoyment by all children, particularly to the interactive drama workshops. Further evidence of child engagment with the programme was demonstrated by children’s clear understanding of programme messages around marketing, moderation and food labelling. Thirteen of the intervention schools were deemed to be fully engaged with HeLP and qualitative data revealed a high level of teacher ‘buy in’, due to the programme’s compatability with the National Curriculum, level of teacher support and use of innovative and creative delivery methods by external drama practitioners.ConclusionOur trial shows that it is possible to successfully scale up complex school-based interventions, engage schools and children across the socio-economic spectrum and deliver an intervention as designed. As programme integrity was maintained throughout the HeLP trial, across all intervention schools, we can be confident that the trial findings are a true reflection of the effectiveness of the intervention, enabling policy recommendations to be made.Trial registrationISRCTN15811706.Electronic supplementary materialThe online version of this article (10.1186/s12966-017-0616-6) contains supplementary material, which is available to authorized users.

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“…Babatunde O A2017 [36] Overweight Public USA Seniors RCT 412 Not applicable Julia Lawton 2017 [37] Diabetes Public England Researchers Interview 22 Not applicable J. Lloyd 2017 [38] Overweight Public England Children Implementation research 1324 Not applicable David A. Rorie2017 [39] Hypertension Public England NR Implementation research…”

Section: Na Not Applicablementioning

confidence: 99%

How to improve participant compliance in clinical trials: A Scoping Review of process factors

Lin

Liang

et al. 2020

Preprint

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Background The reliability of results can be compromised when subsets of participants who remain on a study differ from those who drop out. Although recent studies have investigated approaches for improving compliance, there has been very little investigation of process factors, regardless of the type of literature and the publication date. factors that may influence how and why compliance may be successful (or not). Aim To identify process factors that may influence participant compliance retention in clinical trials, and potential approaches to improve the compliance, from published studies, to facilitate future design and implementation of trials. Methods Six databases and two clinical trial registries were searched on November 29, 2019. Surveys, interviews, retrospective data analyses, theoretical research, reviews and clinical studies aiming at investigating factors influencing participant compliance and potential approaches for improving compliance retention were included. Data synthesis followed an iterative process to develop a list of process factors and potential retention approaches. Results were analysed descriptively, including visualization using word cloud. Results 181 publications were included in this review, composed of 58 retrospective analysis of RCTs based on 1,132 clinical trials with 177804 participants, 27 implementation researches, 22 theoretical researches, 20 interviews, 18 surveys, 17 randomized controlled trials, 8 literature reviews, 5 systematic review and meta analysis, 3 mixed methods researches, 2 case report and 1 cohort study. We identified 70 process factors that may affect the compliance. The most commonly addressed factors were age, education, economy, trust in clinical trials, supporting from surrounding people, safety concerns and effectiveness. We found 44 potential approaches to improve compliance. Approaches reported most frequently were that researchers should pay attention to the changes on participants' psychological condition, try their best to build good relationships, provide some compensation and educate the participants about compliance. Conclusion These factors that may affect the compliance can help researchers predict participants who are less likely to adhere and develop screening tools to find efficiently their suitable participants. These potential approaches that may improve the compliance provide suggestions for improving compliance.

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The impact of active stakeholder involvement on recruitment, retention and engagement of schools, children and their families in the cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP): a school-based intervention to prevent obesity

Cited by 17 publications

References 32 publications

Effectiveness of the Healthy Lifestyles Programme (HeLP) to prevent obesity in UK primary-school children: a cluster randomised controlled trial

Effectiveness of the Healthy Lifestyles Programme (HeLP) to prevent obesity in UK primary-school children: a cluster randomised controlled trial

Intervention fidelity in the definitive cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP) trial: findings from the process evaluation

How to improve participant compliance in clinical trials: A Scoping Review of process factors

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The impact of active stakeholder involvement on recruitment, retention and engagement of schools, children and their families in the cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP): a school-based intervention to prevent obesity

Cited by 17 publications

References 32 publications

Effectiveness of the Healthy Lifestyles Programme (HeLP) to prevent obesity in UK primary-school children: a cluster randomised controlled trial

Effectiveness of the Healthy Lifestyles Programme (HeLP) to prevent obesity in UK primary-school children: a cluster randomised controlled trial

Intervention fidelity in the definitive cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP) trial: findings from the process evaluation

How to improve&nbsp;participant compliance&nbsp;in clinical trials: A Scoping Review of process factors

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How to improve participant compliance in clinical trials: A Scoping Review of process factors