The Optimising Family Engagement in HENRY (OFTEN) Study

NCT02675699 | Completed Phase 3

• 1 other identifier: RG.AUHE.102510
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Level of parent compliance to HENRY content measured via self-reported changes in frequency that fruits and vegetables are consumed each day by infants

  12 months post randomisation

• Parenting self-efficacy

  12 months post randomisation

• Eating behaviours

  12 months post randomisation

• Family activity

  12 months post randomisation

• Daily intake of key indicator foods in infants

  12 months post randomisation

Other Outcomes (1)

• Cost effectiveness measured using acceptability curves

  12 months post randomisation

Study Arms (2)

Optimisation + HENRY

EXPERIMENTAL

Behavioral: Optimisation + HENRY

HENRY as standard

ACTIVE COMPARATOR

Behavioral: HENRY as standard

Interventions

Optimisation + HENRY BEHAVIORAL

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.

Optimisation + HENRY

HENRY as standard BEHAVIORAL

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.

HENRY as standard

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

Medicine and Health

Leeds, ls2 9jt, United Kingdom

Location

Related Publications (2)

• 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 and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial. Trials. 2021 Nov 5;22(1):773. doi: 10.1186/s13063-021-05757-w.

  PMID: 34740373 RESULT

• Bryant M, Burton W, Cundill B, Farrin AJ, Nixon J, Stevens J, Roberts K, Foy R, Rutter H, Hartley S, Tubeuf S, Collinson M, Brown J. Effectiveness of an implementation optimisation intervention aimed at increasing parent engagement in HENRY, a childhood obesity prevention programme - the Optimising Family Engagement in HENRY (OFTEN) trial: study protocol for a randomised controlled trial. Trials. 2017 Jan 24;18(1):40. doi: 10.1186/s13063-016-1732-3.

  PMID: 28115006 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NIHR Career Development Fellow

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 5, 2016
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 25, 2022

Record last verified: 2019-07

Locations

GB (1)