The main aim of the EuroFIT trial is to assess the effectiveness and cost-effectiveness of the EuroFIT programme in supporting men to achieve an increase of at least 1000 steps per day (about 10 minutes on average per day, or 70 minutes per week)…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Glucose metabolism disorders (incl diabetes mellitus)
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures are changes to total sedentary time (i.e. minutes per
day) and total physical activity (i.e. steps per day) at 12 months objectively
measured with ActivPAL.
Secondary outcome
Secondary outcomes are changes in self-reported physical activity and sedentary
time, food intake, body weight, BMI, waist circumference, diastolic and
systolic blood pressure, cardio-metabolic disease risk biomarkers related to
glucose, insulin, HbA1c, lipids and liver function, self-reported general
physical health, wellbeing, self-esteem, vitality and quality of life. Cost
effectiveness will be assessed and a process evaluation will be conducted.
Outcomes for the replication measures (comparison group only) are changes to
total sedentary time (i.e. minutes per day) and total physical activity (i.e.
steps per day) objectively measured with ActivPAL after participation in the
program by the comparison group since 12 month measures. Additional outcomes
are weight, BMI, waist, self reported wellbeing, food intake and injuries.
Background summary
Low levels of physical activity are associated with increased risk of a number
of chronic diseases including heart disease and diabetes. More recently, it has
become clear that time spent sedentary (i.e. sitting down) is a risk factor for
these diseases independent of time spent in physical activity. Thus,
interventions to increase physical activity and reduce sitting are likely to
reduce cardio-metabolic disease risk. Current *lifestyle* intervention
programmes aimed at reducing cardio-metabolic disease risk attract relatively
few men (<30% of participants) and generally attract participants with
relatively high socio-economic status (SES). Thus, men, particularly those from
lower SES groups, are an under-represented and *hard-to-reach* group with
respect to lifestyle interventions to improve cardio-metabolic health. The
European Commission-funded EuroFIT aims to address this important public health
concern by leveraging the allegiance that many men across the SES spectrum have
for their football teams, to develop and trial a sustainable
lifestyle-intervention programme in adult male fans of top-level football clubs
in England, the Netherlands, Norway and Portugal.
EuroFIT builds on recent experience with the evidence-based Football Fans in
Training (FFIT) programme in Scotland. The Scottish FFIT programme was
specifically designed as a gender-sensitised programme to attract men with
BMI>=28, aged 35-65, to lose weight, become more active and adopt healthy
lifestyles, and to maintain these changes to at least 12 months. FFIT was
successful in recruiting men from across the socio-economic spectrum who were
at high risk of future ill health, and who reported the football club setting
as the key draw of the programme for them. The Scottish FFIT programme helped
men lose weight and maintain their weight loss over 12 months; the mean
difference in weight loss at 12 months between the intervention and control
group, adjusted for baseline weight and club, was 4.94 kg (95% CI 3.95-5.94)
and mean percentage weight loss, similarly adjusted, was 4.36% (3.64-5.08),
both in favour of the intervention group (p<0•0001). (Hunt et al, 2014 Lancet)
Following the successes of the Scottish FFIT programme, the programme was
adpated to other European countries, amonst others the Netherlands.
Study objective
The main aim of the EuroFIT trial is to assess the effectiveness and
cost-effectiveness of the EuroFIT programme in supporting men to achieve an
increase of at least 1000 steps per day (about 10 minutes on average per day,
or 70 minutes per week) and a decrease of at least 25 minutes per day spent
sitting, at least 12 months after their participation in EuroFIT.
Study design
A two arm, stratified, individually randomized within clubs, pragmatic,
controlled trial to assess the effect of the EuroFIT programme with an embedded
process evaluation across 4 European countries.
Intervention
The EuroFIT programme is designed to support men to become more active, less
sedentary, improve their diet, and maintain these changes long term. It is
delivered through twelve, weekly, 90-minute, group sessions delivered by club
community coaching staff.
They include classroom-based learning activities and physical activity training
using club facilities.
The programme is gender-sensitised in relation to context, content and style of
delivery. In relation to context, deliverydelivery through top professional
football clubs aims to attract men by tapping into the powerful loyalty and
affiliation they feel towards the club they support and to engage them by
appealing to their existing identities as football fans.
In relation to content, the men receive scientific information delivered simply
(*science but not rocket science*) and a *toolbox* of skills and behaviour
change techniques they can apply to make changes and maintain them long-term.
The men also receive a state-of-the-art self-monitoring device (the SitFIT)
that allows them to self-monitor increases in physical activity (through
walking) and time spent standing/sitting in their daily lives. In relation to
style of delivery, the programme is designed to maximise the time spent in
interaction with peers and coaches on specific topics to encourage vicarious
learning and mutual support. Clubs will also organise a re-union session, which
will take place at a time of the clubs* choosing after the programme has
finished.
Coaches are trained to provide a positive social environment that supports men
to make changes that suit them in the context of their own lives.
Study burden and risks
The following procedures will be used to ensure the potential for significant
risk to participants and coaches is minimal:
• As recommended in SIGN guidance, participants will be screened for
contraindications to exercise using the Physical Activity Readiness
Questionnaire (PAR-Q+). Men who answer *yes* on one of the section 2 questions
of the PAR-Q+ will be excluded.
• Men found to have elevated blood pressure at baseline measurement sessions
(systolic >= 140mmHg and/or diastolic >= 90mmHg) will be encouraged to consult
their GP. They will be given a letter providing information about their blood
pressure readings, and records will be kept of all letters issued.
• Men found to have elevated blood pressure at baseline measurement sessions
(systolic >= 160mmHg and/or diastolic >= 100mmHg) will be encouraged to consult
their GP. They will be given a letter providing information about their blood
pressure readings, and records will be kept of all letters issued. They will be
allowed to participate in the EuroFIT programme, however, coaches will not
allow them to undertake vigorous activity as part of the coach-led physical
activity component of the programme, until they have provided evidence to their
coach that their blood pressure is released. They will be encouraged to
undertake moderate intensity walking activities.
• Coaches will be trained in tailoring physical activity programmes for men of
varying levels of fitness.
• Coaches will also be trained to teach participants to use the Rate of
Perceived Exertion (RPE) Scale to assist men in exercising at moderate
intensity levels.
van der Boechorststraat 7
Amsterdam 1081BT
NL
van der Boechorststraat 7
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ISRCTN | ISRCTN81935608 |
CCMO | NL53236.029.15 |