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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Veröffentlicht in:	BMJ open Jg. 14; H. 3; S. e081861
Hauptverfasser:	Bryant, Maria, Burton, Wendy, Collinson, Michelle, Martin, Adam, Copsey, Bethan, Groves-Williams, Dawn, Foster, Alexis, Willis, Thomas A, Garnett, Philip, O'Cathain, Alicia
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	England British Medical Journal Publishing Group 25.03.2024 BMJ Publishing Group LTD BMJ Publishing Group
Schriftenreihe:	Protocol
Schlagworte:	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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Abstract	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.
AbstractList	One-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.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.This 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.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.Ethical 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.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.ISRCTN16529380.TRIAL REGISTRATION NUMBERISRCTN16529380. 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. One-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. This 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. Ethical 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. ISRCTN16529380. Introduction One-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 analysis This 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 dissemination Ethical 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 number ISRCTN16529380.
Author	O'Cathain, Alicia Bryant, Maria Martin, Adam Groves-Williams, Dawn Willis, Thomas A Burton, Wendy Copsey, Bethan Garnett, Philip Collinson, Michelle Foster, Alexis
AuthorAffiliation	5 Sheffield centre for Health and Related Research , University of Sheffield , Sheffield , UK 7 School for Business and Society , University of York , York , UK 1 Hull York Medical School , University of York , York , UK 4 Academic Unit of Health Economics Leeds Institute of Health Sciences , University of Leeds , Leeds , UK 6 Leeds Institute for Health Sciences , University of Leeds , Leeds , UK 2 Department of Health Sciences , University of York , York , UK 3 Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research , University of Leeds , Leeds , UK
AuthorAffiliation_xml	– name: 4 Academic Unit of Health Economics Leeds Institute of Health Sciences , University of Leeds , Leeds , UK – name: 7 School for Business and Society , University of York , York , UK – name: 1 Hull York Medical School , University of York , York , UK – name: 2 Department of Health Sciences , University of York , York , UK – name: 3 Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research , University of Leeds , Leeds , UK – name: 5 Sheffield centre for Health and Related Research , University of Sheffield , Sheffield , UK – name: 6 Leeds Institute for Health Sciences , University of Leeds , Leeds , UK
Author_xml	– sequence: 1 givenname: Maria orcidid: 0000-0001-7690-4098 surname: Bryant fullname: Bryant, Maria email: maria.bryant@york.ac.uk organization: Department of Health Sciences, University of York, York, UK – sequence: 2 givenname: Wendy surname: Burton fullname: Burton, Wendy organization: Department of Health Sciences, University of York, York, UK – sequence: 3 givenname: Michelle surname: Collinson fullname: Collinson, Michelle organization: Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK – sequence: 4 givenname: Adam surname: Martin fullname: Martin, Adam organization: Academic Unit of Health Economics Leeds Institute of Health Sciences, University of Leeds, Leeds, UK – sequence: 5 givenname: Bethan orcidid: 0000-0001-9783-6549 surname: Copsey fullname: Copsey, Bethan organization: Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK – sequence: 6 givenname: Dawn orcidid: 0000-0002-4834-8503 surname: Groves-Williams fullname: Groves-Williams, Dawn organization: Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK – sequence: 7 givenname: Alexis orcidid: 0000-0002-7978-2791 surname: Foster fullname: Foster, Alexis organization: Sheffield centre for Health and Related Research, University of Sheffield, Sheffield, UK – sequence: 8 givenname: Thomas A surname: Willis fullname: Willis, Thomas A organization: Leeds Institute for Health Sciences, University of Leeds, Leeds, UK – sequence: 9 givenname: Philip surname: Garnett fullname: Garnett, Philip organization: School for Business and Society, University of York, York, UK – sequence: 10 givenname: Alicia orcidid: 0000-0003-4033-506X surname: O'Cathain fullname: O'Cathain, Alicia organization: Sheffield centre for Health and Related Research, University of Sheffield, Sheffield, UK
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Snippet	IntroductionOne-fifth of children start school already overweight or living with obesity, with rates disproportionately impacting those living in the most... One-fifth of children start school already overweight or living with obesity, with rates disproportionately impacting those living in the most deprived areas.... Introduction One-fifth of children start school already overweight or living with obesity, with rates disproportionately impacting those living in the most...
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SubjectTerms	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
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Title	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
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