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

Abstract

Background Poor 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. Methods We 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. Results Neither 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). Conclusions During 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 registration ClinicalTrials.govNCT02675699. Registered on 4 February 2016

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).…”

“…Seventeen outcome domains were identified (Table 2). Anthropometry and body composition was the most frequently collected outcome domain (n = 41 interventions, collected in 91% of included interventions, Table 2); only four interventions 48,55,70,72,86 did not collect anthropometric outcomes. The next most commonly collected outcome domains were physical activity (n = 38, 84%), dietary intake (n = 32, 71%), environmental (n = 32, 71%), and sedentary behavior (n = 28, 62%).…”

Effectiveness and cost-effectiveness of a sustainable obesity prevention programme for preschool children delivered at scale ‘HENRY’ (Health, Exercise, Nutrition for the Really Young): protocol for the HENRY III cluster randomised controlled trial

“…We have developed a recruitment strategy based on learning from our feasibility study 18 which includes screening and consenting by centre staff (who are familiar to families) and detailed training for centre staff, including clear timelines and expectations. For example, in order to meet targets, a minimum of four parents should be recruited within a 6-week window prior to the start of each HENRY programme (and at an equivalent time in control centres).…”

“…Although HENRY was designed to be a universal programme, it has been predominantly delivered in children’s centres/community venues located in areas of high deprivation. Evidence suggests it has potential to impact on population obesity 18 but its effectiveness is not yet established. The current trial adopts a novel approach to evaluate the effectiveness and cost-effectiveness of the programme and explore the potential role of HENRY in disrupting the multiple factors that influence excess weight gain in the system.…”

“…Following on from a successful feasibility study, 18 our current evaluation will consider child obesity outcomes in the short-term (using data collected in the trial), medium-term (using routinely collected data at 3 years) and longer-term (using economic modelling and secondary datasets).…”