The Optimising Family Engagement in HENRY (OFTEN) Study

Childhood Obesity Clinical Trial

— OFTEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675699
• Other study ID #: RG.AUHE.102510
• Status: Completed
• Phase: Phase 3
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: July 2019
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Local authorities:

• Local authorities providing data from at least 4 Children's Centres
• Courses delivered by trained staff who have been certified by HENRY

Children's Centres:

• At least one course to be delivered per Centre per year
• Sites with a history of providing process data for the previous year. 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. - Exclusion Criteria:

Local authorities:

• Areas which have plans to decommission the HENRY intervention during the course of the trial; or who are not planning on running HENRY programmes during the trial period.

Children's Centres:

• Centres where ethnography has taken place during Study 2
• Centres who are not planning on running HENRY programmes during the trial period

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Medicine and Health	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Bryant M, Burton W, Collinson M, Farrin A, Nixon J, Stevens J, Roberts K, Foy R, Rutter H, Copsey B, Hartley S, Tubeuf S, Brown J. A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	12 months post randomisation
Primary	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.	12 month post randomisation (allowing 3 months for Optimisation intervention implementation and collecting data from 1- 2 HENRY courses per site).
Secondary	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	12 months post randomisation
Secondary	Parenting self-efficacy	Adapted Parenting Self-Agency Measure; Parenting self-agency measure (Dumka 1996)	12 months post randomisation
Secondary	Eating behaviours	Golan (1998) Family Eating and Activity Habits Questionnaire	12 months post randomisation
Secondary	Family activity	Bespoke HENRY brief activity questionnaire	12 months post randomisation
Secondary	Daily intake of key indicator foods in infants	Modified validated Food Frequency Questionnaire (Hammond 1993)	12 months post randomisation