NCT02675699

The Optimising Family Engagement in HENRY (OFTEN) Study

Effectiveness of an Implementation Optimisation Intervention Aimed at Increasing Parent Engagement in HENRY, a Childhood Obesity Prevention Programme: a Cluster Randomised Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: University of Leeds · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This study will test whether parent engagement (recruitment, attendance) in a Childhood obesity prevention programme (HENRY) can be improved in local authorities randomised to receive an Optimisation intervention (in addition to standard HENRY) compared to those continuing to deliver the programme as standard.

Detailed description

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. AIM: To evaluate the effectiveness of a recently developed 'Optimisation intervention' to optimise parent engagement in a community based obesity prevention programme 'HENRY', using routinely collected process data from existing sites commissioned to deliver HENRY in the UK DESIGN: Multi-centre, cluster randomised controlled trial. As research will judge the ability of local authorities and their Centres to optimise implementation of HENRY, a cluster randomised design, has been chosen with local authority as the unit of randomisation. Local authorities will be randomised in a 1:1 allocation ratio (HENRY+ Optimisation Intervention; HENRY alone control) by a statistician at Leeds CTRU, using minimisation algorithm with random element, stratifying on baseline level of implementation (proportion of Centres meeting none of the 2 primary outcome implementation criteria/ meeting 1 or 2 of the criteria)) size of local authorities (number of Children's Centres (\< 10/ ≥10)) and area deprivation (≤10% /\>10% ranking within Index of Multiple Deprivation at the Lower Layer Super Output Area). Consent to participate will be sought at the cluster level (local authorities) and from the Centres within each local authority using an opt-out approach. CONTROL ARM: HENRY delivered as standard. HENRY (Health, Exercise, Nutrition for the Really Young) is an 8-week programme delivered in Children's Centres (CCs), aiming to provide parents with skills and knowledge to support healthy lifestyles in preschool children and their families. It was set up in 2006 with Department of Health support aimed at reversing rising trends in school entry age obesity. HENRY is currently delivered in 32 local areas across England and Wales by trained health and community practitioners. ACTIVE ARM: HENRY as standard plus an optimisation intervention to enhance parent engagement (recruitment and attendance) in the 8 week programme. A tailored 'Optimisation' intervention has been developed with a NIHR funds (CDF 2014-07-052) to support local authorities and Children's Centres to promote HENRY implementation, based on observations of positive deviants, interviews with Children Centre staff and other stakeholders, and input from parents. The resulting optimisation package is a multi-component intervention implemented at multi-levels (local authorities, Centres, parents). Precise details can not currently be disclosed to do risk of contamination. ANALYSIS: Primary outcome analysis will be on the intention-to treat Population using a 3-level hierarchical model, with courses (or participants) nested within CCs within LA, adjusting for randomization minimisation variables. Differences in parent engagement, corresponding 95% CI, p-values and ICCs will be reported.

Conditions

• Childhood Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Optimisation + HENRY	HENRY HENRY is an 8-week childhood obesity prevention programme delivered in Children's Centres in the UK by trained practitioners, aiming to provide parents with skills and knowledge to support healthy lifestyles in preschool children and their families. The programme aims to build parents' skills, knowledge and confidence to change old habits and provide healthier nutrition. OPTIMISATION A tailored 'Optimisation' intervention has being developed to support local authorities and Children's Centres to promote HENRY implementation, based on an ethnography of Children Centres, including interviews with staff and other stakeholders and input from parents. Development was underpinned by strong theories of behaviour change and will be guided by the intervention planning framework; the Behaviour Change wheel using a systematic approach. Strategies have been developed to improve parent motivation to enrol on to HENRY and promote parent self-efficacy to continue to attend.
BEHAVIORAL	HENRY as standard	Local Authorities / Children's Centres that are assigned to the control group will continue with standard HENRY practice. Current HENRY QA practice involves the review of process data by HENRY central office with provision of written and oral feedback. This will continue in both trial arms and will be monitored.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2016-02-05
• Last updated: 2022-03-25

Locations

1 site across 1 country: United Kingdom