European Fans in Training (EuroFIT): A multicentre randomised controlled trial of a gender-sensitised programme to increase physcal activity and reduce sedentary time delivered to men aged 30-65 in elite European football clubs
- Conditions
- blood pressurecardiovascular diseasediabetes100244501008220610018424
- Registration Number
- NL-OMON43569
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 320
- men;
- aged 30 to 65 (based on self-report data at initial screening);
- who have a self-reported BMI >=27 kg/m2 at initial screening;
- who consent to randomisation.
- who do not provide at least 4 out of 7 days of usable data from objective measurement of physical activity/sedentary time (activPAL) at baseline. This will be checked by researchers preceding further baseline measurement, men will be provided with an extra possibility to wear the activPAL when providing not enough data is due to malfunctioning of the device, if time permits;
- who answer *yes* on one of the section 2 questions of the self-reported PAR-Q+ screening instrument;
- who already participate in some sort of health promotion programme at their club, when the trial starts.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measures are changes to total sedentary time (i.e. minutes per<br /><br>day) and total physical activity (i.e. steps per day) at 12 months objectively<br /><br>measured with ActivPAL. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are changes in self-reported physical activity and sedentary<br /><br>time, food intake, body weight, BMI, waist circumference, diastolic and<br /><br>systolic blood pressure, cardio-metabolic disease risk biomarkers related to<br /><br>glucose, insulin, HbA1c, lipids and liver function, self-reported general<br /><br>physical health, wellbeing, self-esteem, vitality and quality of life. Cost<br /><br>effectiveness will be assessed and a process evaluation will be conducted.<br /><br><br /><br>Outcomes for the replication measures (comparison group only) are changes to<br /><br>total sedentary time (i.e. minutes per day) and total physical activity (i.e.<br /><br>steps per day) objectively measured with ActivPAL after participation in the<br /><br>program by the comparison group since 12 month measures. Additional outcomes<br /><br>are weight, BMI, waist, self reported wellbeing, food intake and injuries. </p><br>