A Phase 3 interventional study of Optimisation + HENRY and HENRY as standard in Childhood Obesity, sponsored by University of Leeds. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2022-03-25.
Sponsored by University of Leeds · Phase 3, Interventional, and Health services research
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 126 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
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Local authorities:
Children's Centres:
There will be no exclusions based on the demographics of Children's Centres, but location will be monitored to ensure inclusion of those with diverse social and environmental characteristics.
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Exclusion Criteria:
Local authorities:
Children's Centres:
Behavioral: Optimisation + HENRY
Behavioral: HENRY as standard
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.
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.
Number of parents engaging with the HENRY programme measured using Centre level process data
Centre level data: A combined outcome of parent engagement based on the number of parents recruited per course and the attendance rate. In order to be effective, courses need improve parent engagement and retain parents to continue on the course.
Time frame: 12 month post randomisation (allowing 3 months for Optimisation intervention implementation and collecting data from 1- 2 HENRY courses per site).
Level of parent compliance to HENRY content measured via self-reported changes in frequency that fruits and vegetables are consumed each day by infants
Compliance will be measured using a proxy of parent reported frequency of consumption of fruits /vegetables by children/ day/ course. This will be assessed at the parent-level as a binary variable
Time frame: 12 months post randomisation
Parenting self-efficacy
Adapted Parenting Self-Agency Measure Parenting self-agency measure (Dumka 1996)
Time frame: 12 months post randomisation
Eating behaviours
Golan (1998) Family Eating and Activity Habits Questionnaire
Time frame: 12 months post randomisation
Family activity
Bespoke HENRY brief activity questionnaire
Time frame: 12 months post randomisation
Daily intake of key indicator foods in infants
Modified validated Food Frequency Questionnaire (Hammond 1993)
Time frame: 12 months post randomisation
Cost effectiveness measured using acceptability curves
Economic evaluation of the Optimisation intervention. Commissioner willingness to pay for the Optimisation Intervention. The true value of the optimised intervention will be ascertained following discussions with the commissioners to determine their willingness to pay. Recruitment and attrition will be categorised as achieved or not (binary) at the centre-level, although continuous data will also be provided to aid commissioners discussion from the willingness to pay analysis.
Time frame: 12 months post randomisation
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Plan to share: Undecided — Data IP is held with the HENRY organisation
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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University of Leeds