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

Elizabeth Stamp, Holly Schofield, Victoria Laurina Roberts, Wendy Burton, Michelle Collinson, June Stevens, Amanda Farrin, Harry Rutter, Maria Bryant

Research output: Contribution to journalArticlepeer-review

3 Citations (SciVal)

Abstract

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.
Original languageEnglish
JournalPilot and Feasibility Studies
Volume7
Issue number1
DOIs
Publication statusPublished - 26 Mar 2021

Funding

MB conceived the study and secured the funding with support from AJF. All authors contributed to the design of the trial, which is included in this nested qualitative study. WB, HS and ES conducted the interviews and HS and ES analysed the data. All authors contributed to the writing of the manuscript. The authors read and approved the final manuscript and prepared a draft manuscript. We thank all parents who took part in this study and all children?s centre staff and commissioners for recruiting participants and facilitating the HENRY programme courses. We acknowledge our parent advisory group for their support in developing the intervention and ongoing advice in study design and recruitment (Amal Najlat, Chloe Anderson, Kelly Milner, Claire Donkin, Sarah Young, Terri Francis and Rachael Baptista). We thank the members of the TSC, including Professor Peymane Adab (TSC Chair, University of Birmingham), Professor Alicia O?Cathain (mixed methods expert, University of Sheffield), Professor Kelvin Jordan (statistical expertise, Keele University), Dr. Thomas Willis (behaviour change expertise, University of Leeds) and Amal Najlat (parent representative). The study was funded by the National Institute of Health Research (NIHR)’s Academy awarded to the Chief Investigator [MB] (CDF-2014-07-052). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

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