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

Abstract

BackgroundCommunity 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.MethodsWe 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.ResultsWe recruited two local authorities and 12 children’s centres within eight months. 117 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.ConclusionOur 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 registrationClinicalTrials.gov Identifier NCT03333733 registered 6th November 2017

Contamination within trials of community-based public health interventions: lessons from the HENRY feasibility study

“…We used qualitative methods (interviews and focus groups) to explore contamination within the HENRY feasibility study [ 17 ] [Bryant et al, submitted at same time to Pilot and Feasibility Studies]. The feasibility study was an NIHR funded, multicentre, two-arm, cluster RCT.…”

“…The feasibility study was an NIHR funded, multicentre, two-arm, cluster RCT. The protocol is reported elsewhere [ 17 ]. In brief, the study aimed to recruit 120 parents across 12 children’s centres in two local authorities (governments).…”

“…The extent and implications of contamination in trials assessing the effectiveness of community-based public health interventions are not fully understood [ 16 ], particularly for parent and child interventions [ 10 ]. We therefore aimed to investigate contamination within a randomised feasibility study of HENRY; a UK community-based childhood obesity prevention programme [ 17 ] [Bryant et al, submitted at same time to Pilot and Feasibility Studies].…”

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

“…The study methods have been reported in detail elsewhere [18] and are presented more brie y below. Following study commencement, three key protocol amendments were made: (1) Follow-up was reduced from 12 to 11 months due to an unexpected delay in the ethical approval process (approved by the Trial Steering Committee); (2) Additional consent was requested at follow-up to access HENRY programme attendance data; and (3) Telephone interviews were conducted with parents in the process evaluation to replace focus groups, which were not well attended.…”

“…Parents in the intervention arm attended the eight-week HENRY (Health, Exercise, Nutrition for the Really Young) programme delivered in children centre's to groups of 8-10 parents. Programme details are documented elsewhere [13,18,19]. In brief, it aims to provide parents with the skills and knowledge to support a healthy lifestyle in preschool children and their families.…”