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

Abstract

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.

The range of outcomes and outcome measurement instruments collected in multisectoral community‐based obesity prevention interventions in children: A systematic review

“…After full‐text screening, an additional 37 studies were identified. These included 20 studies 5,70–88 reporting 12 additional interventions and 17 studies 89–105 reporting outcomes from the interventions included in the review by Karacabeyli et al but those published after July 2017. The search of the clinical trial registries, the gray literature, and reference lists of included studies identified an additional 32 studies for inclusion in our review (Figure 1).…”

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

“…The priority placed on the delivery of HENRY programmes or similar may be influenced by stakeholder perceptions of whether the programme can demonstrate an effect [ 62 ], but these data are rarely available for public health obesity prevention programmes delivered at scale. In this study, we applied a novel approach to evidence generation through the conduct of a comprehensive early-phase (evidentiary) intervention enhancement and evaluation [ 13 ] prior to testing the feasibility of assessing the effectiveness of HENRY [ 15 ]. This is in contrast to conventional implementation research, which would usually be conducted following definitive randomised evaluations to determine clinical effectiveness (in this case, childhood obesity prevention).…”

“…We developed and evaluated an intervention to optimise the implementation of an existing pre-school obesity prevention group programme, HENRY (Health, Exercise, Nutrition for the Really Young), prior to assessing the feasibility of undertaking a randomised controlled trial of its effectiveness in work which has been previously been published [ 14 , 15 ]. HENRY is an 8-week programme delivered to groups of parents of preschool children.…”

Assessing the impact of obesity interventions in the early years: a systematic review of UK-based studies

“…Out of the 217 international studies, five studies (six trials) were conducted in the UK and were included in the final review. [34][35][36][37][38] One study was conducted in Lancashire, 34 one in Glasgow, 35 one in two areas in North and Central…”

“…The four preventative trials include the Be active, Eat healthy/Healthy Heroes 34 intervention, the ToyBox 35 intervention, the Health Exercise Nutrition for the Really Young (HENRY) 36 programme, and the Planet Munch programme, trial 2. 38 Three out of four trials (Be Active, Eat healthy/Healthy Heroes, ToyBox, HENRY) focused on disadvantaged families or deprived areas.…”