Protocol for Healthy Habits Happy Homes (4H) Scotland: feasibility of a participatory approach to adaptation and implementation of a study aimed at early prevention of obesity.

introductionPrevention of childhood obesity is an important public health objective. Promoting healthful energy balance related behaviours (EBRBs) in the early years should be a key focus. In Scotland, one in five children are overweight or obese by age 5 years, with levels highest in deprived areas. This study protocol outlines the stages of a feasibility study to translate the highly promising North American Healthy Habits, Happy Homes (4H) a home based, preschool childhood obesity prevention intervention to Scotland (4H Scotland). First, elements of participatory and co-production approaches utilised to: (a) engage key stakeholders, (b) enable inclusive recruitment of participants and (c) adapt original study materials. Second, 4H Scotland intervention will be tested within a community experiencing health/social inequalities and high levels of deprivation in Dundee, Scotland. METHODS AND ANALYSIS: 4H Scotland aims to recruit up to 40 families. Anthropometry, objective and subjective measures of EBRBs will be collected at baseline and at 6 months. The intervention consists of monthly visits to family home, using motivational interviewing and SMS to support healthful EBRBs: sleep duration, physical activity (active play), screen time, family meals. The Control Group will receive standard healthy lifestyle information. Fidelity to intervention will be assessed using recordings of intervention visits. Feasibility and acceptability of study design components will be assessed through qualitative interviews and process evaluation of recruitment, retention rates; appropriateness, practicality of obtaining outcome measures; intervention duration, content, mode of delivery and associated costs. Adaptation through participatory and co-production will support development of 4H Scotland. Process evaluation offers two future directions; advancement towards a definitive, larger trial or routine practice. ETHICS AND DISSEMINATION: This study was granted ethical approval by the University of Strathclyde's School of Psychological Sciences and Health Ethics Committee. Results will be disseminated through lay summaries workshops, peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN13385965; Pre-results.