title: Effectiveness of an implementation optimisation intervention aimed at increasing parent engagement in HENRY, a childhood obesity prevention programme - the Optimising Family Engagement in HENRY (OFTEN) trial: study protocol for a randomised controlled trial.
abstract: Family-based interventions to prevent childhood obesity depend upon parents' taking action to improve diet and other lifestyle behaviours in their families. Programmes that attract and retain high numbers of parents provide an enhanced opportunity to improve public health and are also likely to be more cost-effective than those that do not. We have developed a theory-informed optimisation intervention to promote parent engagement within an existing childhood obesity prevention group programme, HENRY (Health Exercise Nutrition for the Really Young). Here, we describe a proposal to evaluate the effectiveness of this optimisation intervention in regard to the engagement of parents and cost-effectiveness.
  
  
  
  The Optimising Family Engagement in HENRY (OFTEN) trial is a cluster randomised controlled trial being conducted across 24 local authorities (approximately 144 children's centres) which currently deliver HENRY programmes. The primary outcome will be parental enrolment and attendance at the HENRY programme, assessed using routinely collected process data. Cost-effectiveness will be presented in terms of primary outcomes using acceptability curves and through eliciting the willingness to pay for the optimisation from HENRY commissioners. Secondary outcomes include the longitudinal impact of the optimisation, parent-reported infant intake of fruits and vegetables (as a proxy to compliance) and other parent-reported family habits and lifestyle.
  
  
  
  This innovative trial will provide evidence on the implementation of a theory-informed optimisation intervention to promote parent engagement in HENRY, a community-based childhood obesity prevention programme. The findings will be generalisable to other interventions delivered to parents in other community-based environments. This research meets the expressed needs of commissioners, children's centres and parents to optimise the potential impact that HENRY has on obesity prevention. A subsequent cluster randomised controlled pilot trial is planned to determine the practicality of undertaking a definitive trial to robustly evaluate the effectiveness and cost-effectiveness of the optimised intervention on childhood obesity prevention.
  
  
  
  ClinicalTrials.gov identifier: NCT02675699 . Registered on 4 February 2016.
authors.affiliation: Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS29JT, UK. m.j.bryant@leeds.ac.uk.
authors.forename: Maria
authors.identifier: 0000-0001-7690-4098
authors.initials: M
authors.lastname: Bryant
authors.affiliation: Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS29JT, UK.
authors.forename: Wendy
authors.initials: W
authors.lastname: Burton
authors.affiliation: Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS29JT, UK.
authors.forename: Bonnie
authors.initials: B
authors.lastname: Cundill
authors.affiliation: Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS29JT, UK.
authors.forename: Amanda J
authors.initials: AJ
authors.lastname: Farrin
authors.affiliation: Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS29JT, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Nixon
authors.affiliation: Department of Nutrition, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC, 27599, USA.|Department of Epidemiology, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC, 27599, USA.
authors.forename: June
authors.initials: J
authors.lastname: Stevens
authors.affiliation: HENRY Head Office, 8 Elm Place, Old Witney Road, Eynsham, OX29 4BD, UK.
authors.forename: Kim
authors.initials: K
authors.lastname: Roberts
authors.affiliation: Academic Unit of Primary Care, Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT, UK.
authors.forename: Robbie
authors.initials: R
authors.lastname: Foy
authors.affiliation: London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.
authors.forename: Harry
authors.initials: H
authors.lastname: Rutter
authors.affiliation: Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS29JT, UK.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Hartley
authors.affiliation: Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT, UK.
authors.forename: Sandy
authors.initials: S
authors.lastname: Tubeuf
authors.affiliation: Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS29JT, UK.
authors.forename: Michelle
authors.initials: M
authors.lastname: Collinson
authors.affiliation: Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS29JT, UK.
authors.forename: Julia
authors.initials: J
authors.lastname: Brown
mesh_terms: D003153:Community Health Services / Q000191:economics; D003362:Cost-Benefit Analysis; D000072001:Diet, Healthy; D015444:Exercise; D005196:Family Therapy / Q000191:economics / Q000379:methods*; D006184:Habits; D017048:Health Care Costs; D006801:Humans; D010290:Parents / Q000523:psychology*; D063766:Pediatric Obesity / Q000175:diagnosis / Q000191:economics / Q000517:prevention & control* / Q000523:psychology; D011314:Preventive Health Services / Q000191:economics / Q000379:methods*; D012107:Research Design; D012307:Risk Factors; D040242:Risk Reduction Behavior; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
keywords: Childhood obesity; Engagement; Implementation; Parent; Recruitment; Trial