Abstract
BACKGROUND: This study aims to evaluate the feasibility and acceptability of the PhunkyFoods Programme, a primary school-based intervention to promote healthy nutrition and physical activity knowledge and behaviours to assess outcomes to inform a phase 3 trial. METHODS: The cluster randomised feasibility trial recruited eight primary schools from the North of England. Elibility criteria included all primary schools in one town, excluding independent and special schools and schools that comprised of only key stage 2 pupils (years 3-6). Eight schools agreed to participate. Randomisation to intervention or control arms was in a 1:1 ratio. Intervention schools received PhunkyFoods over 17 months. Control schools continued with usual curriculum. Assessors were blinded to group assignment. Measures comprised of a Healthy Lifestyle Knowledge Questionnaire and Synchronised Nutrition and Activity Program to assess diet and physical activity, height, weight, and psychological wellbeing. Feasibility outcomes were recruitment, attrition rates, interviews with teaching staff, focus groups with pupils to explore the acceptability of outcome measures, implementation, intervention content, and programme fidelity. RESULTS: Three hundred fifty-eight pupils, aged 6-9 years from eight schools were recruited at baseline (control n = 170, intervention n = 188); 337 (94.1%) at 6 months (control n = 163, intervention n = 181); and 331 (92.5%) at 18 months (control n = 152, intervention n = 179), and 6 pupils opted out. Trends in increased knowledge of healthy lifestyle behaviours, healthier eating, and liking of fruit and vegetables were reported in the intervention compared to the control group. Year 4 intervention pupils had significantly higher healthy balanced diet knowledge scores compared to control pupils, mean difference 5.1 (95% CI 0.1 to 10.1, p=0.05). At 18 months, the mean percentage of vegetables liked was higher (intervention 53.9% vs. 43.0% control). Similarly, percentage of fruits liked was also higher (intervention 76.9% vs. 67.2% control). Qualitative data showed that delivery of the intervention was feasible and acceptable to teachers and pupils. Lessons were learned to inform the phase 3 trial around the dietary assessment measure and timing of recruitment. CONCLUSIONS: Whilst the study was not powered to detect a definitive effect, results suggest a potential to increase knowledge of healthy lifestyle behaviours and dietary behaviours, suggesting that with minor changes, a phase 3 trial is likely to be deliverable. TRIAL REGISTRATION: ISRCTN, ISRCTN15641330. Registered 8 May 2015-retrospectively registered, 10.1186/ISRCTN15641330.