Childhood Obesity Clinical Trial
— OFTENOfficial title:
Effectiveness of an Implementation Optimisation Intervention Aimed at Increasing Parent Engagement in HENRY, a Childhood Obesity Prevention Programme: a Cluster Randomised Controlled Trial
Verified date | July 2019 |
Source | University of Leeds |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Medicine and Health | Leeds |
Lead Sponsor | Collaborator |
---|---|
University of Leeds |
United Kingdom,
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
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 |
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