Effectiveness and cost-effectiveness of a sustainable obesity prevention programme for preschool children delivered at scale ‘HENRY’ (Health, Exercise, Nutrition for the Really Young): protocol for the HENRY III cluster randomised controlled trial

IntroductionOne-fifth of children start school already overweight or living with obesity, with rates disproportionately impacting those living in the most deprived areas. Social, environmental and biological factors contribute to excess weight gain and programmes delivered in early years settings ai...

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Vydáno v:BMJ open Ročník 14; číslo 3; s. e081861
Hlavní autoři: Bryant, Maria, Burton, Wendy, Collinson, Michelle, Martin, Adam, Copsey, Bethan, Groves-Williams, Dawn, Foster, Alexis, Willis, Thomas A, Garnett, Philip, O'Cathain, Alicia
Médium: Journal Article
Jazyk:angličtina
Vydáno: England British Medical Journal Publishing Group 25.03.2024
BMJ Publishing Group LTD
BMJ Publishing Group
Edice:Protocol
Témata:
Body mass index
Child, Preschool
Childrens health
Collaboration
Community child health
Cost analysis
Cost-Benefit Analysis
Cost-Effectiveness Analysis
Exercise
Feasibility studies
Health disparities
Health services
Humans
Intervention
Multicenter Studies as Topic
Nutrition
Obesity
Objectives
Overweight
Parents & parenting
Pediatric Obesity - prevention & control
Prevention
Primary Prevention
Prospective Studies
Public Health
Quality of Life
Randomized Controlled Trial
Randomized Controlled Trials as Topic
United Kingdom > UK
PUBLIC HEALTH
Obesity
Primary Prevention
Randomized Controlled Trial
Community child health
ISSN:2044-6055, 2044-6055
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Shrnutí:IntroductionOne-fifth of children start school already overweight or living with obesity, with rates disproportionately impacting those living in the most deprived areas. Social, environmental and biological factors contribute to excess weight gain and programmes delivered in early years settings aim to support families to navigate these in order to prevent obesity. One of these programmes (Health, Exercise and Nutrition for the Really Young, HENRY) has been delivered in UK community venues (hereon named ‘centres’) in high deprivation areas since 2008 and aims to help families to provide a healthy start for their preschool children. We aim to establish the effectiveness and cost-effectiveness of HENRY, including its potential role from a wider systems perspective.Methods and analysisThis is a multicentre, open-labelled, two-group, prospective, cluster randomised controlled trial, with cost-effectiveness analysis, systems-based process evaluation and internal pilot. Primary analysis will compare body mass index (BMI) z-score at 12 months in children (n=984) whose parents have attended HENRY to those who have not attended. Secondary outcomes include parent and staff BMI and waist circumference, parenting efficacy, feeding, eating habits, quality of life, resource use and medium term (3 years) BMI z-scores (child and siblings). 82 centres in ~14 local authority areas will be randomised (1:1) to receive HENRY or continue with standard practice. Intention-to-treat analysis will compare outcomes using mixed effects linear regression. Economic evaluation will estimate a within-trial calculation of cost-per unit change in BMI z-score and longer-term trajectories to determine lifelong cost savings (long-term outcomes). A systems process evaluation will explore whether (and how) implementation of HENRY impacts (and is impacted by) the early years obesity system. An established parent advisory group will support delivery and dissemination.Ethics and disseminationEthical approval has been granted by the University of York, Health Sciences’ Research Governance Committee (HSRGC/2022/537/E). Dissemination includes policy reports, community resources, social media and academic outputs.Trial registration numberISRCTN16529380.
Bibliografie:Protocol
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ObjectType-Evidence Based Healthcare-3
SourceType-Scholarly Journals-1
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ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2023-081861