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

Contamination occurs when participants allocated to trial control arms receive elements of the active intervention. Randomisation at cluster level, rather than individual level, may reduce or eliminate contamination, avoiding the dilution of intervention effectiveness that it may cause. However, cluster randomisation can result in selection bias and may not be feasible to deliver. We explored the extent of contamination in a qualitative study nested within a feasibility study of HENRY (Health, Exercise and Nutrition for the Really Young); a UK community-based child obesity prevention programme. We aimed to determine the nature and impact of contamination to inform a larger planned trial and other trials in community based public health settings.