Title: Implementation optimisation and pilot cluster randomised controlled trial of HENRY, a community based programme aimed at preventing obesity in pre-school children
Funder: Department of Health and Social Care

Abstract: BACKGROUND: Rising rates of obesity in preschool children are alarming and emphasise the need for evidence-based approaches to prevent obesity, which can be successfully implemented in communities. Although robust, theory-based prevention programmes exist, it is often a challenge to get parents to attend them and adopt positive behaviour changes in their families. OBJECTIVES: Proposed research consists of two work packages (WP) aiming to 1) optimise the implementation of an obesity prevention programme HENRY' via development and testing of a Step-up' intervention to support local authorities (LAs) to improve parent engagement (recruitment, attendance) and enhance positive behaviour changes in families; and 2) to determine the practicability of undertaking a full trial to evaluate an optimised HENRY' in a pilot RCT with the intent of conducting a definitive trial to test its effectiveness and cost-effectiveness on obesity prevention in future work. HENRY is an 8-week programme currently commissioned across 32 local authorities and delivered in Children's Centres (CCs), combining authoritative parenting skills with practical support to improve family lifestyle behaviours. WP1 DESIGN: Four studies incorporating quantitative and qualitative methodologies utilising routine data. METHODS: Study1: Analysis of existing data from CCs which deliver HENRY to identify those consistently engaging parents and reporting positive family behaviour change (positive deviants) and those failing to engage and support parents. Study 2: Ethnography study, including direct observations of CCs and interviews with stakeholders, to identify barriers and levers to successful implementation.Study 3: Development of the Step-up' intervention to optimise the impact of HENRY, underpinned by strong theories of behaviour change. Intervention components may range from provision of support to LAs to improve infrastructure through to providing extra support to parents to attend and successfully make changes to family lifestyle. Study 4: Cluster RCT recruiting 24 LAs and 96 CCs to evaluate the effectiveness and cost-effectiveness of the Step-up intervention on improvements to implementation within LAs already running HENRY. LAs will be randomised to Step-up or standard HENRY and routine data on parent recruitment, attendance and child consumption of fruits and vegetables will be used as outcomes. Commissioners will be asked to state their willingness-to-pay' for the additional Step-up based on proportional improvements in the programme implementation. WP2 DESIGN: A pilot cluster RCT preceding a definitive trial to test the clinical effectiveness and cost effectiveness of HENRY' to prevent preschool obesity. METHODS: CCs with no history of running HENRY will be randomised to receive either HENRY (+ Step-up as appropriate) or continue standard practice (no intervention). Twelve CCs across 2 LAs will be recruited, from which data will be collected by blinded researchers from 120 parents (60/arm). Eligible parents will have at least 1 child aged 1-5 years. Pilot outcomes include: CC and parent recruitment; training competencies; process evaluation; feasibility and acceptability of trial procedures; and sample size for definitive trial. Data will be collected at baseline (pre-randomisation for CC/pre programme initiation for parents) and follow-up (12 months post-parent consent (CC and parents)). Descriptive analysis will provide 95% confidence intervals for estimates. A funding application will be submitted for the definitive trial if indicated by the pilot study. EXPECTED OUTCOMES/ONGOING IMPROVEMENT TO HEALTH If effective, HENRY will offer extensive benefit to health, including reduced preschool obesity, improved nutrition/eating behaviours in children, healthier family lifestyles and enhanced parenting skills; reducing related morbidity and mortality. Proposed research is imperative to the NHS as it will ultimately provide an evidence-based approach to prevent childhood obesity which is attractive to all stakeholders, including parents. This has expressed need, not just for obesity prevention, but also to support costs of a programme that has already incurred much spending.

Lay abstract: Rising trends in obesity threaten the health of children and adults. Proposed research aims to optimise the implementation of a well-established childhood obesity prevention programme HENRY' and determine the feasibility of conducting a large study to test its impact on preschool obesity. Research begins by developing and testing an approach to promote numbers of parents initiating and attending the programme and to support positive change in lifestyle, before testing the feasibility of running a national study to determine whether it can prevent obesity. Practical approaches that engage parents are needed, with evidence that these offer cost-effective solutions to reduce obesity.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;METABOLIC AND ENDOCRINE;ORAL AND GASTROINTESTINAL;STROKE