Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/09/2011
Date assigned
20/10/2011
Last edited
11/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Being overweight or obese is a major cause of ill health. Many men are overweight or obese, but 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, become more active and live more healthily. Scottish Premier League (SPL) clubs, supported by the SPL Trust, are committed to providing the coaches and facilities to deliver a 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 attend 12 weekly group sessions at the SPL club they support.

Who can participate?
Men aged 35-65 years with a body mass index of at least 28 kg/m2.

What does the study involve?
Participating men will be randomly allocated to either the intervention group or the comparison group. Men in the intervention group will take part in the Football Fans in Training programme, a weight loss, physical activity and healthy living programme consisting of 12 weekly 90-minute sessions of classroom-based discussion and pitch-side training. This study will find out whether the FFIT programme helps men lose at least 5% of their body weight when they are measured one year later compared with the comparison group men who did not take part in FFIT during that time period. The men in the comparison group will be offered a place on FFIT after the study is completed.

What are the possible benefits and risks of participating?
The risks to men taking part in FFIT are very low. However, as some may be disappointed if they lose less weight than other men in their group, the coaches delivering the programme will be trained to give individual support where needed.

Where is the study run from?
Men will take part in FFIT at their local SPL Club.

When is the study starting and how long is it expected to run for?
The study is starting in June 2011 and will run until December 2013.

Who is funding the study?
Delivery of the FFIT programme is funded by the Scottish Government and Football Pools. The study is funded by the National Institute for Health Research Public Health Research programme.

Who is the main contact?
Dr Cindy M Gray
cindy.gray@glasgow.ac.uk

Trial website

http://www.spl-ffit.co.uk

Contact information

Type

Scientific

Primary contact

Prof Sally Wyke

ORCID ID

Contact details

Institute of Health and Wellbeing
College of Social Sciences
27 Bute Gardens
University of Glasgow
Glasgow
G12 8RS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09/3010/06

Study information

Scientific title

Football Fans in Training (FFIT): A randomised controlled trial of a gender-sensitive weight loss and healthy living programme delivered to men aged 35-65 by Scottish Premier League (SPL) football clubs

Acronym

FFIT

Study hypothesis

To determine whether Football Fans in Training (FFIT), a gender-sensitive, weight loss, physical activity and healthy living programme delivered in SPL football clubs, can help men aged 35-65 years with BMI at least 28kg/m2 achieve a 5% reduction in body weight 12 months after the start of their participation in FFIT.

Ethics approval

University of Glasgow College of Social Sciences Ethics Committe for Non Clinical Research Involving Human Subjects approved on 17th May 2011; Ref CSS/2011/029

Study design

Pragmatic two arm stratified randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Overweight and obesity

Intervention

Men in the intervention group will take part in the Football Fans in Training prgramme, an evidence-based, gender-sensitised, weight loss, physical activity and healthy living programme consisting of 12, weekly, 90-minute sessions of 'classroom-based' discussion and 'pitch-side' training. The programme fully adheres to National Institute for Health and Clinical Excellence (NICE) 2006 and Scottish Intercollegiate Guidelines Network (SIGN) 2010 guidance. The comparison group will be offered a place on FFIT following the 12-month follow-up measurements.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Percentage weight loss at 12 months

Secondary outcome measures

1. Percentage weight loss at 12 weeks
2. Percentage reduction in waist circumference and body fat (as measured by bioimpedance) at 12 weeks and 12 months
3. Physical activity: changes in self-reported frequency and duration of walking, moderate and vigorous activity, and sedentary behaviour over the last 7 days at 12 weeks and 12 months measured by the short International Physical Activity Questionnaire
4. Eating habits: changes in self-reported intake of key contributors to weight gain [e.g. fast foods, chocolate bars, chips, pies, sugary drinks] at 12 weeks and 12 months using questions adapted from the Dietary Instrument for Nutrition Education
5. Changes in self-reported alcohol consumption over the last 7 days at 12 weeks and 12
months
6. Reduction in resting blood pressure at 12 weeks and 12 months
7. Psychological outcomes
7.1. Changes in positive and negative affect as measured by the Positive and Negative Affect Schedule
7.2. Changes in self esteem as measured by the Rosenberg Self Esteem Scale
7.3. Changes in health-related quality of life as measured by SF-12, all at 12 weeks and 12 months

Overall trial start date

01/06/2011

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men aged 35-65 years
2. Body mass index (BMI) at least 28kg/m2
3. Have completed the Physical Activity Readiness Questionnaire
4. Willing to consent to weight, height and waist measurements

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

720

Participant exclusion criteria

1. Prior participation in FFIT
2. Men whose measured blood pressure (BP) contraindicates vigorous exercise will be excluded from in stadium training until they can provide evidence of its reduction

Recruitment start date

01/06/2011

Recruitment end date

31/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Glasgow
Glasgow
G12 8RS
United Kingdom

Sponsor information

Organisation

University of Glasgow (UK)

Sponsor details

10 The Square
University of Glasgow
University Avenue
Glasgow
G12 8QQ
United Kingdom
+44 (0)141 330 3875
Paul.Ellis@glasgow.ac.uk

Sponsor type

University/education

Website

http://www.gla.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Public Health Research programme (Ref 09/3010/06)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24457205
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25654156

Publication citations

  1. Results

    Hunt K, Wyke S, Gray CM, Anderson AS, Brady A, Bunn C, Donnan PT, Fenwick E, Grieve E, Leishman J, Miller E, Mutrie N, Rauchhaus P, White A, Treweek S, A gender-sensitised weight loss and healthy living programme for overweight and obese men delivered by Scottish Premier League football clubs (FFIT): a pragmatic randomised controlled trial., Lancet, 2014, 383, 9924, 1211-1221, doi: 10.1016/S0140-6736(13)62420-4.

  2. Results

    Wyke S, Hunt K, Gray CM, Fenwick E, Bunn C, Donnan PT, Rauchhaus P, Mutrie N, Anderson AS, Boyer N, Brady A, Grieve E, White A, Ferrell C, Hindle E, Treweek S, Football Fans in Training (FFIT): a randomised controlled trial of a gender-sensitised weight loss and healthy living programme for men – end of study report.

Additional files

Editorial Notes