Bryant et al. (2021).pdf (1.7 MB)

Cluster randomised controlled feasibility study of HENRY: a community-based intervention aimed at reducing obesity rates in preschool children

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journal contribution
posted on 03.03.2021, 09:58 by Maria Bryant, Michelle Collinson, Wendy Burton, Elizabeth Stamp, Holly Schofield, Bethan Copsey, Suzanne Hartley, Edward Webb, Amanda J. Farrin
Background
Community-based obesity prevention interventions are often commissioned despite the limited evidence base. HENRY (Health, Exercise, Nutrition for the Really Young) is a programme delivered to parents of preschool children across the UK. Early evidence suggests that it may be effective, but a robust evaluation has not been conducted. We initiated a systematic evaluation of HENRY by studying the feasibility of conducting a multi-centre definitive trial to evaluate its effectiveness and cost-effectiveness to prevent obesity. Objectives were to assess the feasibility of recruiting local authorities, centres and parents; test processes and time required to train and certify intervention staff; explore HENRY commissioning processes; identify potential sources (and associated impact) of contamination; and consider the feasibility of trial procedures.

Methods
We conducted a multi-centre, open labelled, two group, prospective, cluster randomised, controlled, feasibility study, with embedded process evaluation and pre-defined criteria for progression to definitive trial. We sought to recruit 120 parents from 12 children’s centres, across two UK local authority (government) areas. Within each local authority, we planned to randomise three centres to HENRY and three to ‘standard care’ control. Our plan was to collect data in family homes at baseline and 12 months, including parent and child height and weight, and parent-reported questionnaires on self-efficacy, feeding, eating habits, quality of life and resource use. Contamination, implementation and study acceptability were explored using parent interviews.

Results
We recruited two local authorities and 12 children’s centres within eight months. One hundred and seventeen parents were recruited (average 3.9 parents per programme) and follow-up data were collected from 85% of participants. Process data from 20 parents and 24 members of staff indicate that both would benefit from more detail about their involvement as participants, but that methods were acceptable. Contamination was likely, though the impact of this on behaviour was unclear.

Conclusion
Our findings indicate that a cluster RCT of HENRY to assess its effect on childhood obesity prevention is feasible. This study has allowed us to design a pragmatic definitive trial with minimal bias, taking account of lessons learnt from conducting evaluation research in public health settings.

Trial registration
ClinicalTrials.gov Identifier NCT03333733 registered 6th November 2017.

Funding

National Institute of Health Research (NIHR)’s Academy awarded to the Chief Investigator [MB] (CDF-2014-07-052)

History

School

  • Sport, Exercise and Health Sciences

Published in

Pilot and Feasibility Studies

Volume

7

Issue

1

Publisher

BMC

Version

VoR (Version of Record)

Rights holder

© The Authors

Publisher statement

This is an Open Access Article. It is published by BMC under the Creative Commons Attribution 4.0 International Licence (CC BY 4.0). Full details of this licence are available at: https://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Acceptance date

15/02/2021

Publication date

2021-02-26

Copyright date

2021

ISSN

2055-5784

eISSN

2055-5784

Language

en

Depositor

Dr Elizabeth Stamp. Deposit date: 2 March 2021

Article number

59