BackgroundThe prevalence of male obesity is increasing alongside low uptake of existing weight management programmes by men. Football Fans in Training (FFIT) is a group-based, weight management and healthy living programme delivered by community coaches.ObjectivesTo assess (1) the effectiveness and cost-effectiveness of FFIT, (2) fidelity of delivery and (3) coach and participant experiences of FFIT.DesignA two-arm, pragmatic, randomised controlled trial; associated cost-effectiveness [in terms of incremental cost per quality-adjusted life-year (QALY) within trial and over individuals’ lifetimes]; and process evaluation. Participants were block randomised in a 1 : 1 ratio, stratified by club; the intervention group started FFIT within 3 weeks and the comparison group were put on a 12-month waiting list.SettingThirteen professional football clubs in Scotland, UK.ParticipantsA total of 747 men aged 35–65 years with an objectively measured body mass index (BMI) of ≥ 28 kg/m2.InterventionsFFIT was gender sensitised in context, content and style of delivery. A total of 12 weekly sessions delivered at club stadia combined effective behaviour change techniques with dietary information and physical activity sessions. Men carried out a pedometer-based walking programme. A light-touch maintenance programme included six e-mails and a reunion session at 9 months. At baseline, both groups received a weight management booklet, feedback on their BMI and advice to consult their general practitioner if blood pressure was high.Primary outcomeMean difference in weight loss between groups at 12 months expressed as absolute weight and a percentage. Intention-to-treat analyses used all available data.Data sourcesObjective measurements, questionnaires, observations, focus groups and coach interviews.ResultsA total of 374 men were allocated to the intervention and 333 (89%) completed 12-month assessments; a total of 374 were allocated to the comparator and 355 (95%) completed 12-month assessments. At 12 months, the mean difference in weight loss between groups, adjusted for baseline weight and club, was 4.94 kg [95% confidence interval (CI) 3.95 kg to 5.94 kg]; percentage weight loss, similarly adjusted, was 4.36% (95% CI 3.64% to 5.08%), in favour of the intervention (p < 0.0001). Sensitivity analyses gave similar results. Pre-specified subgroup analyses found no significant predictors of primary outcome. Highly significant differences in favour of the intervention were observed for objectively measured waist, percentage body fat, systolic and diastolic blood pressure, and self-reported physical activity, diet and indicators of well-being and physical aspects of quality of life. Eight serious adverse events were reported, of which two were reported as related to FFIT participation. From the within-trial analysis, FFIT was estimated to cost £862 per additional man maintaining a 5% weight reduction at 12 months and £13,847 per additional QALY, both compared with no intervention. For a cost-effectiveness threshold of £20,000/QALY, the probability that FFIT is cost-effective, compared with no active intervention, is 0.72. This probability rises to 0.89 for a cost-effectiveness threshold of £30,000/QALY. From the longer-term analysis, FFIT was estimated to cost £2535 per life-year gained and £2810 per QALY gained. FFIT was largely delivered as intended. The process evaluation demonstrated the powerful draw of football to attract men at high risk of ill health. FFIT was popular and analyses suggest that it enabled lifestyle change in ways that were congruent with participants’ identities.ConclusionsParticipation in FFIT led to significant reductions in weight at 12 months. It was cost-effective at standard levels employed in the UK, attracted men at high risk of future ill health and was enjoyable. Further research should investigate whether or not participants retained weight loss in the long term, how the programme could be optimised in relation to effectiveness and intensity of delivery and how group-based programmes may operate to enhance weight loss in comparison with individualised approaches.Study registrationCurrent Controlled Trials ISRCTN32677491.FundingScottish Government and The Football Pools funded the delivery of FFIT. National Institute for Health Research Public Health Research programme funded the evaluation and will be published in full inPublic Health Research; Vol. 3, No. 2. See the NIHR Journals Library website for further project information.
Intervenții în managementul greutății
