To assess the behavioural and weight status outcomes in English children in a feasibility study of a novel primary school-based obesity prevention programme.
Exploratory cluster randomised controlled trial of the Healthy Lifestyles Programme.
Four city primary schools (two control and two intervention) in the South West of England.
202 children aged 9–10 years, of whom 193 and 188 were followed up at 18 and 24 months, respectively. No child was excluded from the study; however, to be eligible, schools were required to have at least one single Year 5 class.
Four-phase multicomponent programme using a range of school-based activities including lessons, assemblies, parents' evenings, interactive drama workshops and goal setting to engage and support schools, children and their families in healthy lifestyle behaviours. It runs over the spring and summer term of Year 5 and the autumn term of Year 6.
Primary and secondary outcomes
Weight status outcomes were body mass index, waist circumference and body fat standard deviation scores (SDS) at 18 and 24 months, and behavioural outcomes were physical activity, television (TV) viewing/screen time and food intake at 18 months.
At 18 months of follow-up, intervention children consumed less energy-dense snacks and more healthy snacks; had less ‘negative food markers’, more ‘positive food markers’, lower mean TV/screen time and spent more time doing moderate-vigorous physical activity each day than those in the control schools. Intervention children had lower anthropometric measures at 18 and 24 months than control children, with larger differences at 24 months than at 18 months for nearly all measures.
Results from this exploratory trial show consistent positive changes in favour of the intervention across all targeted behaviours, which, in turn, appear to affect weight status and body shape. A definitive trial is now justified.
To present behavioural and weight status outcomes from an exploratory cluster randomised controlled trial of a novel school-based obesity prevention programme with English primary school children.
To present sample size estimates required for a definitive trial of the programme based on outcome results, attrition rates and estimates of the intraclass correlations of the outcome measures.
The Healthy Lifestyles Programme (HeLP) has been developed using behaviour change theory and extensive stakeholder involvement to engage and support children and their families in healthy lifestyles.
Behavioural and weight status outcomes at 18 and 24 months from this exploratory trial (Phase 3 pilot) show consistency in the direction of effects, all in favour of the intervention, demonstrating ‘proof of concept’.
Results from the exploratory trial have provided sufficient evidence to support the evaluation of HeLP in a full-scale trial.
Strengths and limitations of this study
The HeLP intervention has undergone a systematic development process using research evidence, behavioural theory, stakeholder consultation and piloting. This has enabled the researchers to gain a deeper understanding of the context in which the intervention was to be delivered in order to maximise engagement at all levels. The exploratory trial presented in this paper (Phase 3 pilot) has demonstrated not only that the design of the trial is feasible, with outcome data obtained from 92% of the original cohort at 24 months after transition to secondary school, but also that behavioural and weight status outcome measures at 18 and 24 months show consistency in the direction of effects (although the differences are relatively small), all in favour of the intervention, demonstrating ‘proof of concept’. This shows that a definitive trial of HeLP is both feasible and justified.
The study was conducted in the South West of England, where the population is predominantly white, and although there are areas of deprivation, none of the four schools had ≥25% of children eligible for free school meals (the national average of proportion of children eligible for free school meals). However, the intervention has been developed to allow the flexibility and adaptation to ensure that it is recognising and responding to the local needs of children and families from different socioeconomic and ethnic groups while still maintaining fidelity. Food intake and television (TV) viewing/screen time were self-reported, and although children were asked to sit in their literacy tables so that appropriate support could be provided to each child during completion, the information children are able to provide is limited. We did, however, go to great lengths to ensure that the questionnaires were simple and presented in such a way so as to trigger recall.