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Trial reportTrials2021

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.

Maria Bryant, Wendy Burton, Michelle Collinson, Amanda Farrin, Jane Nixon, June Stevens, Kim Roberts, Robbie Foy, Harry Rutter, Bethan Copsey and 3 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02675699 (Effectiveness of an Implementation Optimisation Intervention Aimed at Increasing Parent Engagement in HENRY, a Childhood Obesity Prevention Programme), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02675699 phase3completednot on this map

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

TypeinterventionalSponsorUniversity of LeedsRan2015 to 2017Enrolled126ConditionsChildhood ObesityArmsOptimisation + HENRY, HENRY as standard
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Maria BryantDepartment of Health Sciences and the Hull York Medical School, University of York, YO105DD, York, UK. maria.bryant@york.ac.uk.ORCID http://orcid.org/0000-0001-7690-4098
Wendy BurtonDepartment of Health Sciences and the Hull York Medical School, University of York, YO105DD, York, UK.
Michelle CollinsonClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
Amanda FarrinClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
Jane NixonClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
June StevensDepartments of Nutrition and Epidemiology, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC, 27599, USA.
Kim RobertsHENRY Head Office, 8 Elm Place, Old Witney Road, Eynsham, OX29 4BD, UK.
Robbie FoyAcademic Unit of Primary Care, Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT, UK.
Harry RutterLondon School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.
Bethan CopseyClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
Suzanne HartleyClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
Sandy TubeufAcademic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT, UK.
Julia BrownClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.

Funding

Research Trainees Coordinating Centre CDF-2014-07-052
6 · The paper itself

Abstract

backgroundPoor and variable implementation of childhood obesity prevention programmes reduces their population impact and sustainability. We drew upon ethnographic work to develop a multi-level, theory-based implementation optimisation intervention. This intervention aimed to promote parental enrolment and attendance at HENRY (Health Exercise Nutrition for the Really Young), a UK community obesity prevention programme, by changing behaviours of children's centre and local authority stakeholders.

methodsWe evaluated the effectiveness of the implementation optimisation intervention on HENRY programme enrolment and attendance over a 12-month implementation period in a cluster randomised controlled trial. We randomised 20 local government authorities (with 126 children's centres) to HENRY plus the implementation optimisation intervention or to HENRY alone. Primary outcomes were (1) the proportion of centres enrolling at least eight parents per programme and (2) the proportion of centres with a minimum of 75% of parents attending at least five of eight sessions per programme. Trial analyses adjusted for stratification factors (pre-randomisation implementation of HENRY, local authority size, deprivation) and allowed for cluster design. A parallel mixed-methods process evaluation used qualitative interviews and routine monitoring to explain trial results.

resultsNeither primary outcome differed significantly between groups; 17.8% of intervention centres and 18.0% of control centres achieved the parent enrolment target (adjusted difference - 1.2%; 95% CI - 19.5%, 17.1%); 17.1% of intervention centres and 13.9% of control centres achieved the attendance target (adjusted difference 1.2%; 95% CI - 15.7%, 18.1%). Unexpectedly, the trial coincided with substantial national service restructuring, including centre closures and reduced funds. Some commissioning and management teams stopped or reduced delivery of both HENRY and the implementation optimisation intervention due to competing demands. Thus, at follow-up, HENRY programmes were delivered to approximately half the number of parents compared to baseline (n = 433 vs. 881).

conclusionsDuring a period in which services were reduced by external policies, this first definitive trial found no evidence of effectiveness for an implementation optimisation intervention promoting parent enrolment to and attendance at an obesity prevention programme.

trial registrationClinicalTrials.gov NCT02675699 . Registered on 4 February 2016.

Indexed as

Pediatric ObesityAnthropology, CulturalChildHumansParentsAttendanceCommunityEngagementEnrolmentObesityParent

Identifiers

PMID34740373
PMCPMC8569980

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.