Objective To assess (1) the feasibility of delivering a culturally adapted weight management programme, Healthy Dads, Healthy Kids United Kingdom (HDHK-UK), for fathers with overweight or obesity and their primary school-aged children, and (2) the feasibility of conducting a definitive randomised controlled trial (RCT).
Design A two-arm, randomised feasibility trial with a mixed-methods process evaluation.
Setting Socioeconomically disadvantaged, ethnically diverse localities in West Midlands, UK.
Participants Fathers with overweight or obesity and their children aged 4–11 years.
Intervention Participants were randomised in a 1:2 ratio to control (family voucher for a leisure centre) or intervention comprising 9 weekly healthy lifestyle group sessions.
Outcomes Feasibility of the intervention and RCT was assessed according to prespecified progression criteria: study recruitment, consent and follow-up, ability to deliver intervention, intervention fidelity, adherence and acceptability, weight loss, using questionnaires and measurements at baseline, 3 and 6 months, and through qualitative interviews.
Results The study recruited 43 men, 48% of the target sample size; the mean body mass index was 30.2 kg/m2 (SD 5.1); 61% were from a minority ethnic group; and 54% were from communities in the most disadvantaged quintile for socioeconomic deprivation. Recruitment was challenging. Retention at follow-up of 3 and 6 months was 63%. Identifying delivery sites and appropriately skilled and trained programme facilitators proved difficult. Four programmes were delivered in leisure centres and community venues. Of the 29 intervention participants, 20 (69%) attended the intervention at least once, of whom 75% attended ≥5 sessions. Sessions were delivered with high fidelity. Participants rated sessions as ‘good/very good’ and reported lifestyle behavioural change. Weight loss at 6 months in the intervention group (n=17) was 2.9 kg (95% CI −5.1 to −0.6).
Conclusions The intervention was well received, but there were significant challenges in recruitment, programme delivery and follow-up. The HDHK-UK study was not considered feasible for progression to a full RCT based on prespecified stop–go criteria.
Trial registration number ISRCTN16724454.
- feasibility studies
- weight loss
- healthy lifestyle
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Twitter @drlauraljones, @philmorgo
Contributors KJ, PA, AB, CC, AD, EF, LJ, MP, MS, MY and PM conceived the study; KJ was the principal investigator; YS undertook the statistical analysis; PH was the senior statistician; TG was the study coordinator and led the process evaluation; LJ was the qualitative lead; TG and KH undertook the qualitative interviews and analysis; PM and CC conceived and designed the original Healthy Dads, Healthy Kids intervention; PM and MY advised on training and delivery; CC and EM advised on dietary assessment; AE was the PPI lead; TG and KJ drafted the manuscript; all authors interpreted the findings, commented on paper drafts and agreed on the final version.
Funding Study funding was granted in October 2015 by the National Institute of Health Research (NIHR) Public Health Research programme (Ref 14/185/13); KJ is partly funded by NIHR Collaborations for Leadership and Health Research and Care West Midlands. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.
Competing interests PM and CC designed the original Healthy Dads, Healthy Kids Programme in Australia.
Patient consent for publication Not required.
Ethics approval Ethical approval for the two phases of the study was obtained from the University of Birmingham Science, Technology, Engineering and Mathematics Ethical Review Committee (16 January 2017, ethics reference; ERN_16–1323).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request.
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