Objectives: To investigate: long term weight, other physical, behavioural and psychological outcomes up to 3.5 years after the start of the RCT; predictors, mediators and men’s qualitative experiences of long term weight loss; cost-effectiveness; and the potential of long term follow up via medical records.
Design: A mixed methods, longitudinal cohort study.
Setting: 13 professional Scottish football clubs from the RCT, and 16 additional Scottish clubs delivering FFIT in 2015/16.
Participants: 665 men aged 35-65 years at RCT baseline (intervention group, N=316; comparison group N=349) who consented to follow up after the RCT, and 511 men in 2015/16 FFIT deliveries.
Interventions: None as part of this study.
Primary outcome: Objectively-measured weight change from RCT baseline to 3.5 years.
Results: 488/665 men (73.4%) attended 3.5-year measurements. The FFIT follow up intervention group sustained a weight loss from baseline of 2.90kg (95%CI 1.78, 4.02, p<0.001); 32.2% (75/233) weighed ≤5% less than at baseline. The FFIT follow up comparison group (who participated in routine deliveries of FFIT after the RCT) lost 2.71kg (1.65, 3.77, p<0.001): 31.8% (81/255) achieved ≥5% weight loss. Both groups showed long term improvements in: body mass index, waist circumference, percentage body fat, blood pressure, self-reported physical activity (PA) (including walking); consumption of fatty and sugary foods, fruit and vegetables, and alcohol; portion 4 sizes; self-esteem; positive and negative affect; and physical and mental health-related quality of life (HRQoL). Mediators included: self-reported PA (including walking) and sitting time; fatty and sugary foods, and fruit and vegetables; portion sizes; self-esteem; positive affect, physical HRQoL; self-monitoring of weight; autonomous regulation, internal locus of control, perceived competence, and relatedness to other FFIT participants and family members. In qualitative interviews, men described continuing to self-monitor weight and PA. Many felt PA was important for weight control, walking remained popular, and most were still aware of portion sizes and tried to eat fewer snacks. FFIT was associated with an incremental cost-effectiveness of £10,700-£15,300 per QALY gained at 3.5 years, and around £2,000 per QALY gained in the lifetime analysis. Medical record linkage provided rich information about RCT participants’ clinical health outcomes, and 90% (459/511) men in the 2015/16 FFIT deliveries gave permission for future linkage.
Limitations: Around a third of RCT participants were not followed up. The comparison group’s participation in FFIT post-RCT meant hypothetical control scenarios were used for the cost-effectiveness analysis.
Conclusions: Participation in FFIT under both research (during the RCT) and routine (post-RCT) delivery conditions led to significant long term weight loss.
Future work: Further research should investigate: how to design programmes to improve long term weight loss maintenance; 2) longer term follow up of FFIT RCT participants; 3) very long term follow up via medical record linkage.