Background
Methods
Study design
Participants
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Men;
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aged 30–65 years;
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self-reported BMI ≥27 kg/m2 at initial screening;
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consent to randomisation.
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do not provide at least 4 days of usable data from objective measurement of physical activity/sedentary time over the course of one week (as measured by ActivPAL™ from PAL technologies) at baseline;
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have a contraindication to moderate intensity physical activity as assessed by the adapted Physical Activity Readiness Questionnaire-Plus (PAR-Q+) [17];
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are already participating in a specific health promotion program at the club at the time of screening.
European Fans in Training (EuroFIT) program
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EuroFIT incorporates a specific focus on reducing sedentary time through the integration of a novel pocket-worn technology (the SitFIT developed by PAL technologies) for self-monitoring of sedentary and non-sedentary time and a greater focus on sedentary time in the classroom discussion;
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EuroFIT focuses on physical activity, sedentary behaviour and healthy eating, rather than weight loss (although this is encouraged where appropriate);
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EuroFIT aims to promote sustained lifestyle change by:
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further supporting men to develop self-regulation strategies that increase the value and importance of health behaviours for their own lives [20]; -
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providing even greater emphasis on relapse prevention techniques [21]; -
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embedding between-session and post-program peer support for changing behaviour through social media and game-based social interaction (the MatchFIT app);
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EuroFIT is culturally-sensitised for the different countries to reflect local physical activity and dietary norms.
Comparison group
Data collection
Recruitment
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The Netherlands: ADO Den Haag; FC Groningen; PSV; Vitesse.
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Norway: Rosenborg BK; Strømsgodset IF; Vålerenga Fotball.
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Portugal: Futebol Clube do Porto; Sporting Clube de Portugal; Sport Lisboa e Benfica.
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UK (England): Arsenal FC; Everton FC; Manchester City FC; Newcastle United FC; Stoke City FC.
Randomisation
Blinding
Procedures
Baseline | Post-program | 6 Months | 12 Months | |
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Objective physical activity and sedentary time | ||||
activPALtm micro | X | X | X | |
activPAL wearing diary (sleep, work time) | X | X | X | |
Self-reported behaviours | ||||
Food intake (adapted DINE) | X | X | X | |
Physical activity (IPAQ-short) | X | X | X | |
Domain specific and total sedentary time (Marshall) | X | X | X | |
Sleeping time | X | X | X | |
Standing time | X | X | X | |
Sedentary/active behaviours (Activity Choice Index) | X | X | X | |
Smoking | X | X | X | |
Objective physical measures | ||||
Body height | X | |||
Body weight | X | X | X | |
Waist circumference | X | X | X | |
Resting blood pressure | X | X | X | |
Blood biomarkers | X | X | ||
Self-reported health and psychosocial measures | ||||
Wellbeing (Cantril ladder) | X | X | X | |
Self-esteem (Rosenberg) | X | X | X | |
Vitality | X | X | X | |
Quality of Life (EQ-5D-5 L) | X | X | X | |
Long standing illness, disability or infirmity | X | X | X | |
Joint pain | X | X | X | |
Injuries | X | X | X | |
Self-reported socio demographic moderators | ||||
Age | X | |||
Ethnicity | X | |||
Marital status | X | |||
Education | X | |||
Current employment status | X | |||
Income | X | |||
Self-reported mediators | ||||
Motivation for physical activity (adapted BREQ-2) | X | X | X | |
Ego/Task involvement | X | X | ||
Club identification (Sport Spectator Identification Scale) | X | X | X | |
Weight management strategies | X | X | X | |
Weight loss activities | X | X | X | |
Self-reported mediators (intervention group only) | ||||
Need support of coach | X | |||
Need thwarting by coach | X | |||
Mastery/performance climate | X | |||
Relatedness to group | X | |||
Need satisfaction from physical activity | X | |||
Self-reported cost-effectiveness | ||||
Health-related quality of life (EQ-5D-5 L) | X | X | X | X |
Health care use (iMTA) | X | X | X | |
Consequences for employment (iPCQ) | X | X | X | |
Medication use (iMCQ) | X | X | ||
Travel costs to club | X | X | X | |
Self-reported process evaluation (intervention group only) | ||||
Coaches | X | X | ||
Participants | X | X | X |
Fieldwork staff training
Measurement feasibility study
Procedures to maximise retention to the trial
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Send men an advance reminder that follow-up measurements are upcoming, using a personalised letter/e-mail sent 2–4 weeks ahead of the measurement dates at their club;
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Phone men two weeks before the scheduled post-program and 12 month measurement sessions to arrange an appointment time for the measurements;
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Send a confirmation of the date, time and location of the man’s appointment by e-mail/mail (according to men’s individual preferences);
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Text men in the days leading up to their appointment to remind them about the time, date and location;
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Offer men who do not show up at first measurement visit a second opportunity for measurement at the club;
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Offer men a home/university visit if they cannot attend or fail to attend the follow-up assessments at the club;
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Offer men who have successfully completed a follow-up assessment, a club voucher in appreciation of their time.
Primary outcomes: objective physical activity and sedentary time
Secondary outcomes
Economic evaluation
Process evaluation
Database
Data analyses
Sample size calculations
Effectiveness analysis
Cost-effectiveness analyses
12-month cost-effectiveness
5-year cost-effectiveness
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To which degree the participants will continue to show the behaviour changes achieved during the EuroFIT intervention;
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How the short-term health outcomes measured within the trial (i.e. to 12 months) link to longer term impacts on health (e.g. in terms of impacts on the development of cardiovascular disease, diabetes, etc.);
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What the costs associated with these health impacts are;
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What the quality of life weights, i.e. utility scores, associated with these health impacts are.