Funded projects

Overweight and obesity are major causes of ill-health. Many men are overweight or obese, but men are reluctant to join existing weight loss programmes. Professional football clubs, with their large, mainly male, fan base, have the potential to attract and support men to lose weight and live more healthily. Scottish Premier League (SPL) clubs, supported by the SPL Trust, New Football Pools and Scottish Government, are committed to providing the staff and facilities to deliver a gender-sensitive weight loss and healthy living programme for men aged 35-65 years. This programme is called Football Fans in Training (FFIT) and men who take part in it attend 12 weekly group sessions at the SPL club that they support. This study will evaluate whether the FFIT programme achieves important levels of weight loss in men by conducting a randomised controlled trial.

FFIT will be judged to be successful if significantly more men who take part in the programme have lost at least 5% of their body weight when they are measured one year after the programme in comparison with men who did not take part in FFIT during that time period. Ethical issues for the study include ensuring that men understand the implications of the research and are able to give informed consent to their participation. All aspects of the study will be vetted and approved by an established research ethics committee at one of the participating Universities.

The research will be conducted by an experienced team of public health and health services researchers who are expert in public health nutrition, physical activity, gender, behaviour change, trial design, statistics, health economics, qualitative research methods and health outcome measurement. The researchers already have an excellent working relationship with the SPL Trust, who will deliver the intervention through the clubs. Many of the researchers on this project have worked together successfully in the past.

Costs will cover university staff time, evaluation fieldwork (travel, venue hire, participant recruitment and retention) and feeding the results back to a wide group of people including doctors, public health policy makers, health promotion specialists, managers of football clubs and similar sporting organisations, and to the participants in the study and members of the public.

Design: a two-arm, stratified, RCT of the Football Fans in Training (FFIT) programme (see Appendix 1).

Setting: SPL Club facilities.

Target population: men, aged 35-65, with BMI >28kg/m2.

Intervention: a group-based, weight loss and healthy living programme, specifically designed to engage men, delivered in 12, weekly, 90-minute sessions. It is based on an existing successful gender-sensitive programme (the Camelon model, Gray et al. 2009) and includes all components of successful weight loss programmes described in NICE (2006) and SIGN (2010) guidance. The physical activity component is further enhanced by recent evidence on how to sustain higher levels of physical activity over 12 months (Fitzsimons et al. 2010). For further details of the intervention, see section 8 of the detailed project description.

Measurement of outcomes and duration of follow up (measurements conducted by fieldworkers trained to standard MRC protocols):

Primary outcome: Percentage weight loss (difference between baseline and follow-up weight) at 12 months.

Secondary outcomes:

• Percentage weight loss at 12 weeks;
  
• Percentage reduction in waist circumference and body fat;
  
• Physical activity (PA): changes in self-reported frequency and duration of PA and inactivity (International PA Questionnaire);
  
• Eating habits: changes in self-reported intake of key contributors to weight gain using questions adapted from DINE;
  Changes in self-reported alcohol consumption over last 7 days;
  
• Change in resting blood pressure;
  
• Psychological outcomes: changes in: positive and negative affect (Positive and Negative Affect Schedule); self esteem (Rosenberg
  
• Self Esteem Scale); health-related quality of life (SF-12);
  
• Difference in area under the trend line from baseline to 12 months.

Cost-effectiveness: whether FFIT has the potential to provide a cost-effective use of resources in terms of cost/QALY.

Follow up measurement schedule can be seen in Appendix 1.

Process outcomes (through examination of club databases and focus groups/interviews/observation): Programme reach (uptake, attendance and completion); reasons for drop out and continuation; programme fidelity; acceptability and satisfaction (participants and coaches); experiences of sustaining weight loss and lifestyle changes long term.

Sample size: to detect a difference in weight reduction of 5%, with 80% power and 2-sided significance level, 250 are required in each arm. Because experience suggests a possible 30-40% drop out and loss to follow for a community-based public health intervention, the sample size is inflated to 420 in each arm. All efforts will made to minimise participant attrition.

Planned analyses: quantitative - an intention to treat analysis will compare percentage weight reduction at 12 months, implemented in a regression model stratified by SPL club; qualitative - transcripts will be analysed using a thematic framework focussing on the research questions and any emerging themes; cost effectiveness - the economic model will assess likely costs, effectiveness and cost-effectiveness of the intervention, and link short term outcomes from the RCT to long term impacts on health from the literature.

Project timetable: June-October 11: project set up. June 11- June 13: data collection with recruitment in up to 2 waves. Sept 11 – June 2013: programme observation, focus groups, interviews. July –December 2013: data analysis, public dissemination events and reporting.

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£790,353