van Nassau, Femke and van der Ploeg, Hidde P. and Abrahamsen, Frank and Andersen, Eivind ...

17 Pages·2017·0.74 MB·English

vanNassauetal.BMCPublicHealth (2016) 16:598
DOI10.1186/s12889-016-3255-y
STUDY PROTOCOL Open Access
Study protocol of European Fans in
Training (EuroFIT): a four-country
randomised controlled trial of a lifestyle
program for men delivered in elite football
clubs
FemkevanNassau1 ,HiddeP.vanderPloeg1*,FrankAbrahamsen2,EivindAndersen2,AnnieS.Anderson3,
JudithE.Bosmans4,ChristopherBunn5,MatthewChalmers6,CiaranClissmann7,JasonM.R.Gill8,CindyM.Gray5,
KateHunt9,JudithG.M.Jelsma1,JenniferG.LaGuardia10,PierreN.Lemyre2,DavidW.Loudon11,LisaMacaulay5,
DouglasJ.Maxwell11,AlexMcConnachie12,AnneMartin13,NikosMourselas11,NanetteMutrie13,
RiaNijhuis-vanderSanden14,KylieO’Brien7,HugoV.Pereira15,MatthewPhilpott16,GlynC.Roberts2,JohnRooksby6,
MattiasRost6,ØysteinRøynesdal2,NaveedSattar8,MarleneN.Silva15,MaritSorensen2,PedroJ.Teixeira16,
ShaunTreweek17,TheovanAchterberg18,IrenevandeGlind14,WillemvanMechelen1andSallyWyke5
Abstract
Background: Lifestyle interventions targeting physical activity, sedentarytime and dietary behaviours have the
potential to initiate and support behavioural change and result inpublic health gain. Although men have often
been reluctant to engage in such lifestyle programs, many are athighrisk of several chronic conditions. We have
developed an evidence and theory-based, gender sensitised, health and lifestyle program (EuropeanFans in
Training (EuroFIT)), which is designedto attract men through theloyalty theyfeelto the football club they support.
Thispaper describes thestudy protocol to evaluate theeffectiveness and cost-effectiveness ofthe EuroFIT program
insupportingmento improvetheir level ofphysicalactivityand reduce sedentary behaviour over 12 months.
Methods: TheEuroFITstudyisapragmatic,two-arm,randomisedcontrolledtrialconductedin15footballclubsinthe
Netherlands,Norway,PortugalandtheUK(England).One-thousandmen,aged30to65years,withaself-reportedBody
MassIndex(BMI)≥27kg/m2willberecruitedandindividuallyrandomised.Theprimaryoutcomesareobjectively-assessed
changesintotalphysicalactivity(stepsperday)andtotalsedentarytime(minutesperday)at12monthsafterbaseline
assessment.Secondaryoutcomesareweight,BMI,waistcircumference,restingsystolicanddiastolicbloodpressure,
cardio-metabolicbloodbiomarkers,foodintake,self-reportedphysicalactivityandsedentarytime,wellbeing,self-esteem,
vitalityandqualityoflife.Cost-effectivenesswillbeassessedandaprocessevaluationconducted.
TheEuroFITprogramwillbedeliveredover12weekly,90-minutesessionsthatcombineclassroomdiscussionwithgraded
physicalactivityinthesettingofthefootballclub.Classroomsessionsprovideparticipantswithatoolboxofbehaviour
changetechniquestoinitiateandsustainlong-termlifestylechanges.Thecoacheswillreceivetwodaysoftrainingto
enablethemtocreateapositivesocialenvironmentthatsupportsmeninengaginginsustainedbehaviourchange.
(Continuedonnextpage)
*Correspondence:[email protected]
1DepartmentofPublicandOccupationalHealth,andEMGOInstituteforHealth
andCareResearch,VUUniversityMedicalCenter,VanderBoechorststraat7,
Amsterdam1081BT,TheNetherlands
Fulllistofauthorinformationisavailableattheendofthearticle
©2016TheAuthor(s).OpenAccessThisarticleisdistributedunderthetermsoftheCreativeCommonsAttribution4.0
InternationalLicense(http://creativecommons.org/licenses/by/4.0/),whichpermitsunrestricteduse,distribution,and
reproductioninanymedium,providedyougiveappropriatecredittotheoriginalauthor(s)andthesource,providealinkto
theCreativeCommonslicense,andindicateifchangesweremade.TheCreativeCommonsPublicDomainDedicationwaiver
(http://creativecommons.org/publicdomain/zero/1.0/)appliestothedatamadeavailableinthisarticle,unlessotherwisestated.
vanNassauetal.BMCPublicHealth (2016) 16:598 Page2of15
(Continuedfrompreviouspage)
Discussion:TheEuroFITtrialwillprovideevidenceontheeffectivenessandcost-effectivenessoftheEuroFITprogram
deliveredbyfootballclubstotheirmalefans,andwillofferinsightintofactorsassociatedwithsuccessinmaking
sustainedchangestophysicalactivity,sedentarybehaviour,andsecondaryoutcomes,suchasdiet.
Trialregistration:ISRCTN:81935608.Registered16June2015.
Keywords:Intervention,Randomisedcontrolledtrial,Sedentarybehaviour,Physicalactivity,Diet,Long-termbehaviour
change,Men’shealth,Footballclub,Cardio-metabolichealth,Obesity
Background (3.6, 5.1) greater in the intervention group than the com-
Low levels of moderate to vigorous physical activity, parison group [14]. There were also significant between-
high level of sedentary behaviour and poor diet are group differences in self-reported physical activity and
major threatstopublichealth.Low levels ofmoderate to dietary changes at 12 months, also in favour of the inter-
vigorous physical activity are associated with increased vention group. The process evaluation showed that the
risk of cardiovascular disease, some cancers (breast and group setting (being with other ‘men-like-me’) facilitated
colon in particular) and type 2 diabetes [1, 2]. Sedentary thesebehaviouralchanges[15].
behaviour (any waking activity characterised by an en- European Fans in Training (EuroFIT) builds on the suc-
ergyexpenditure≤1.5metabolicequivalentsandasitting cess of FFIT, and uses the allegiance that many men have
or reclining posture [3]) is also associated with adverse for top professional football clubs in the Netherlands,
health outcomesandincreasedmortality, independentof Portugal, Norway and the UK (England) to attract at-risk
time spent being physically active [4–7]. However, the men to engage in lifestyle changes. EuroFIT extends the
health risks of high levels of sedentary time are often focusofFFITfromweightloss,physicalactivityanddietto
not recognised and are poorly understood by the general includeareductioninsedentarytime.Itmakesamoreex-
public. Our recent meta-analysis demonstrated that in- plicitandextensiveuseoftheoryto support sustainedlife-
terventions focussing primarily on physical activity have style modifications. It incorporates a novel device (the
little effect on sedentary time, whereas those focussing SitFIT™) that allows real-time self-monitoring not only of
holistically on a combination of physical activity, dietary physical activity (through step counts), but also of seden-
and sedentary behaviours are more successful in redu- tary behaviour (sitting time) and non-sedentary behaviour
cing sedentary time [8]. In addition, behavioural inter- (upright time). Finally, participants are also encouraged to
ventions that target physical activity as well as diet are useanapp-basedgame(MatchFIT),designedaspartofthe
also more likely to result in long-term changes in these EuroFITstudy,toencouragesocialsupportaroundphysical
health behavioursandmaintenanceofweightloss [9]. activitybetweensessionsandaftertheendoftheprogram.
Becausepoorphysicalactivity,dietaryandsedentarybe- This paper describes the protocol for a randomised con-
haviours all contribute to increased risks for many of the trolled trial, which aims to evaluate the effectiveness and
same health outcomes, combined lifestyle intervention cost-effectiveness of the EuroFIT program in supporting
programs have the potential to have a substantial public mentoimprovetheirlifestylesversusawaitinglistcompari-
healthimpact.However,mentendtobeunderrepresented son group that is offered the program after the 12-month
in lifestyle change programs, such as weight management follow-up. The primary aim of the trial is to determine
programs [10], and are often considered a high-risk, but whether EuroFIT can help men aged 30–65 years with a
hard-to-reach or underserved group. Men also have self-reportedBodyMassIndex(BMI)≥27kg/m2toincrease
higher risk of diabetes and mortality risks than women at theirphysicalactivityanddecreasetheirsedentarytimeover
the same levels of obesity [11]. In response to this, the 12months.Secondaryoutcomesareweight,BMI,waistcir-
gender-sensitised Football Fans in Training (FFIT) pro- cumference, resting systolic and diastolic blood pressure,
gram was specifically designed to attract overweight and cardio-metabolic blood biomarkers (e.g. glucose, insulin,
obese men (aged 35–65) to a program delivered through HbA1c,lipids and liver function), food intake, self-reported
thetopfootballclubsinScotlandtosupportmeninlosing physical activity and sedentary time, wellbeing, self-esteem,
weight, becoming more active and improving their diet vitalityandqualityoflife.Cost-effectivenesswillbeassessed
[12].FFITwassuccessfulinrecruitingmenathighriskof andaprocessevaluationconducted.
illhealthfromacrossthesocio-economicspectrum;many
reportedthatthefootballclubsettingwasapowerfuldraw Methods
in attracting them to the program [13]. A randomised Studydesign
controlled trial (RCT) of FFITshowed that mean weight This study is a pragmatic two-arm randomised con-
loss at 12 months was 4.9 kg (95 % CI 4.0, 5.9) or 4.4 % trolled trial to assess the effect of the EuroFIT program
vanNassauetal.BMCPublicHealth (2016) 16:598 Page3of15
in four European countries. The trial will be conducted with chronic health conditions, recruitment is aimed
at 15 football clubs in the Netherlands (four clubs), to be inclusive.
Norway (three clubs), Portugal (three clubs) and the UK Inclusioncriteria:
(England; five clubs). In total, 1000 participants will be
recruited. Figure 1 summarises the study design using – Men;
theCONSORTtemplate. – aged30–65 years;
The study was approved in each country by local eth- – self-reportedBMI ≥27 kg/m2atinitialscreening;
ics committees before the start of the EuroFIT study – consent torandomisation.
(Ethics committee of the VU University Medical Center
(2015.184); Regional committees for medical and health Exclusioncriteria:
research ethics, Norway (2015/1862); Ethics Council of
the Faculty of Human Kinetics, University of Lisbon – donotprovide atleast4days ofusable datafrom
(CEFMH 36/2015); Ethics Committee at the University objectivemeasurementofphysicalactivity/sedentary
of Glasgow College of Medicine, Veterinary and Life timeoverthe course ofoneweek(asmeasuredby
Sciences(UK)(200140174)). ActivPAL™fromPALtechnologies)atbaseline;
– haveacontraindication to moderate intensity
Participants physical activity asassessedbythe adapted Physical
Evidence from the process evaluation conducted as ActivityReadinessQuestionnaire-Plus(PAR-Q+)[17];
part of the FFIT RCT suggested that one of the fac- – arealreadyparticipatinginaspecifichealthpromotion
tors that attracted men to the program initially, and programattheclubatthetimeofscreening.
engaged them from the outset, was the recognition it
attracted other men ‘like me’, both in terms of ap- EuropeanFansinTraining(EuroFIT)program
pearance (e.g., size, shape, level of fitness) as well as The EuroFIT program is designed to support men to:
their interest in and allegiance to their football club become more physically active and less sedentary; im-
[13, 15, 16]. In order to maximise the chances that prove their diet; and maintain these changes over the
men signing up for EuroFIT will also have a sense of long term. The EuroFIT program will be delivered over
being with others who were sufficiently ‘like me’, 12, weekly, 90-minute sessions that combine classroom
whilst maximising reach, male football fans aged 30 discussion with graded group-based physical activity led
to 65, with a self-reported BMI ≥27 kg/m2 at initial by community coaches, with one reunion meeting held
screening will be eligible for inclusion. Since a healthy 6–9 months after the program ends. The EuroFIT pro-
lifestyle is beneficial for most people, including those gram has built on the weight management, physical
Fig.1Projectedtrialprofile
vanNassauetal.BMCPublicHealth (2016) 16:598 Page4of15
activity and healthy eating components used in the FFIT participantswithatoolboxofbehaviourchangetechniques,
program[12],but extendsFFIT inthefollowingways: whicharereinforcedandpractisedthroughinteractionand
discussion between participants during face-to-face group
(cid:1) EuroFITincorporatesa specificfocusonreducing sessions.Thematerialsaredesignedtohelpparticipantsto
sedentary timethroughthe integration ofanovel embed the new behaviours into their everyday life so that
pocket-worn technology (the SitFITdevelopedby they are able to maintain these changes in the long term.
PALtechnologies)forself-monitoringofsedentary Participants choose from the skills and strategies in the
andnon-sedentarytimeand agreaterfocuson EuroFITtoolboxtochangetheirphysicalactivity,sedentary
sedentary timeinthe classroomdiscussion; behaviour and diet. Simple, practical, relevant messages
(cid:1) EuroFITfocuses onphysical activity,sedentary allow participants to understand what they can do to per-
behaviourand healthyeating,rather thanweight sonally improve their physical activity, sedentary behaviour
loss(although thisisencouragedwhere and diet. The men are supported to choose to engage in
appropriate); thebehavioursthatpersonallyfitintheirlifeandtodevelop
(cid:1) EuroFITaimstopromotesustainedlifestylechangeby: a clear rationale for why they value these new behaviours.
odrawingmore explicitly onmotivational theories Moreover,interactionswithotherparticipantsprovidesup-
(Self-DeterminationTheory[18]and port to collaboratively tackle challenges and encourage
Achievement GoalTheory[19])toencourage changesbeingmade.Togetherthesecomponentsfosterthe
mento develop internalisedandself-relevant formation of new, self-endorsed, healthy lifestyle routines
motivationforbecomingmoreactive,sittingless thatsustainbehaviourchange.
and eatingahealthierdiet; Self-monitoring of physical activity with a pedometer
ofurthersupportingmentodevelop self- is an effective strategy to improve physical activity be-
regulationstrategies thatincreasethe valueand haviour [24, 25], and proved to be very popular amongst
importanceof health behavioursfortheirown men as one element of the FFIT program [23]. In light
lives [20]; ofthis,EuroFIThasdevelopedtheSitFIT,apocket-worn
oproviding evengreateremphasisonrelapse activity and sedentary/non-sedentary behaviour monitor.
preventiontechniques [21]; The SitFIT provides real time feedback on both step
oembeddingbetween-sessionandpost-program counts and upright (non-sedentary) time and so allows
peer supportforchangingbehaviourthrough participants to actively self-monitor their daily physical
socialmediaand game-basedsocialinteraction activity (steps), sitting time and upright time (time spent
(the MatchFITapp); standing and walking). Participants use their SitFIT to
(cid:1) EuroFITisculturally-sensitised forthedifferent track their progress against an individualised, incremen-
countriestoreflectlocalphysical activity anddietary tal program to increase both their daily step count and
norms. time spent upright. The SitFITcan also display steps and
upright time data over the past seven days, and each
Like FFIT, the program is gender-sensitised in relation participant can obtain a more detailed historical record
to context, content and style of delivery. In relation to of his SitFIT data via computer upload (PC and MAC)
context, delivery through top professional football clubs to the MatchFIT app. MatchFIT has been developed as
aims to attract men either by tapping into the powerful part of the EuroFITstudy to enable between-session so-
loyalty and affiliation that many feel (as self-identified cial support via a chat function, and provides a competi-
football fans) towards the club they support, or by pro- tive element where each club-based EuroFIT group can
viding the opportunity to take part in a program in a compete collectively in a step challenge against a
context that men are likely to see as unthreatening to computer-generated football team, using an algorithm
male identities. In addition, the EuroFITcoaches will be which takes account of the group’s previous week’s step
trained in creating a positive social environment that performance. It should be noted that the competitive
supports men in making changes suited to their own element is not a person-to-person competition. Rather,
routinesandpreferences. the competition is group-based to enhance the social
In relation to content, EuroFIT explicitly targets theory- supportaspectoftheprogram.
derivedmechanismsofaction(e.g.autonomousmotivation, In relation to style of delivery, EuroFIT-licensed coa-
task-orientedgoals),makesuseofthemostevidence-based ches (who receive two days of standardized training to
self-regulationtechniques(e.g.self-monitoring,goalsetting, deliver EuroFIT) help the men feel comfortable and re-
implementation intentions) [22] and is also informed by ceptive to change from the outset by reinforcing the ex-
sociological theory [15] and how gendered identities relate perience that they are with other ‘men-like-me’ and that
tohealthbehaviours[23].Usingthesupportingmanualde- their efforts each week, within and between program
veloped by the EuroFIT consortium, coaches will provide sessions, are valued by the coach and the club. In
vanNassauetal.BMCPublicHealth (2016) 16:598 Page5of15
particular, the coaches are instructed in how to create a will be selected on a country by country basis, with the
motivational, and autonomy- and mastery-supportive criteria for selection being that they promote forms of
climate,and ontheimportance ofunderstandingandre- physical activity that are widely appropriate in their own
specting participants’ perspectives and preferences for country and include country-specific physical activity
lifestyle change. This delivery style aims to promote in- guidelines.
trinsic interest and foster sustained engagement among
participants. The coaches learn to provide a rationale for Data collection
behaviour change, to collaboratively develop behaviour Recruitment
change options for the men to choose from, and to Men willberecruitedthroughthe following clubs:
facilitate the development of participants’ personally-
relevant goals (rather than imposing goals on them). En- (cid:1) TheNetherlands: ADO DenHaag;FCGroningen;
gagement is promoted by ensuring the sessions are en- PSV;Vitesse.
joyable, fun, non-dogmatic, experiential and interactive. (cid:1) Norway: Rosenborg BK;Strømsgodset IF;Vålerenga
Positive banter is encouraged to create a mutually sup- Fotball.
portive ‘team’ environment that helps men to learn from (cid:1) Portugal:FutebolClubedo Porto; Sporting Clube de
each other by sharing tips and advice, whilst facilitating Portugal;Sport LisboaeBenfica.
interactional styles that men are familiar with in other (cid:1) UK(England): ArsenalFC;Everton FC;Manchester
(predominantly) male contexts [26].Importantly, the pro- CityFC;NewcastleUnited FC; StokeCityFC.
gram aims to maximise the time spent interacting with
peers to promote long-term behaviour changes through Participants will be recruited from June 2015 onwards
the collaborative construction of changes to masculine in the Netherlands, Portugal and the UK (England). Due
identitiesandthewaystheyareexpressed[15,23]. to the later start of the football season, recruitment in
Positive feedback and celebration of individual progress Norway will be from November 2015 onwards. Each of
(not just achievement) towards small, short-term goals the 15 clubs across the four countries will recruit up to
[19] helps participants feel competent and confident that 100 interested men who will be invited to an initial visit
they can succeed in their long-term physical activity, sed- to the club to check eligibility. We aim to include a total
entary behaviour, healthy eating targets (as well as weight of1000participantsfor thetrial.
loss, if appropriate). Drawing on Self-Determination and We will use different recruitment strategies matching
Achievement Goal theories and the process evaluation of individual clubs’ preferences. These may include club-
FFIT, men are also encouraged to recognise the personal based activities, such as online publicity (e.g. advertising
value and benefits of the changes that they are making on club/fan websites), e-mail, newsletter or social media
(e.g. feeling fitter, having more energy) [18]. Throughout announcements (i.e. Twitter, Facebook), poster/flyers,
the program, long-term social support [27] is promoted end of season home match-day advertising, face-to-face
within the group by encouraging positive interactions to recruitment at home matches (handing out leaflets and
build relationships during the 12 weekly sessions and by collecting contact details), active involvement of local
encouraging the men to use social media (i.e. WhatsApp, supporters’ organisations and word of mouth. We may
Facebook, etc.) and the MatchFIT app to support each also, where appropriate, publicise the program on na-
other outside the sessions and to meet up between ses- tional football league websites and try to gain media
sions to exercise together, as well as by encouraging the publicity via newspapers (local, regional, national), radio
men to enlist the support of their wider social networks and TVcoverage. In addition, national EuroFIT websites
(e.g.family,friends).Thelight-touchreunionsession(6–9 will be developed to attract men and provide informa-
monthsafter the start ofthe program) provides men with tion aboutparticipation inthetrial.
an opportunity to share their experiences of maintaining Men will be able to register their interest online
the changes they made during the program since the end through a provided link (developed for the study and
oftheinitial12,weeklysessions. linked to the study database). The research team will
then phone all men who have registered an interest in
Comparisongroup taking part in EuroFITas part of the trial (the only way
As a waiting list control group, the comparison group in which the EuroFIT program will be available at this
will be placed on a wait list to be offered a guaranteed time). The researchers will discuss the study and con-
place on the EuroFIT program after their 12 month duct an initial telephone screening for eligibility by ad-
follow-up measurements are completed. In addition, all ministering the PARQ+ and checking that the man is
men (both intervention and comparison group) will re- not already involved in another health-related program
ceive a healthy lifestyle leaflet following the baseline being delivered by the club. Eligible participants will be
measurement and prior to randomisation. These leaflets sent a confirmation e-mail or postal letter, including the
vanNassauetal.BMCPublicHealth (2016) 16:598 Page6of15
participant-information sheet,aconsentform andanap- Participants will be randomly allocated to the EuroFIT
pointment to attend an information meeting at their intervention group or the waiting list comparison group
club. At this information meeting, researchers will ex- in a 1:1 ratio, stratified by football club. The method of
plain the study procedures and inclusion criteria, and randomised permuted blocks will be used, with random
take men’s written informed consent for taking part in block lengths (4 or 6). The randomisation schedule for
the study. Those who agree to take part in the trial will each club will be generated by a computer program and
be asked to indicate in writing whether they are willing stored within the Clinical Trials Unit, with access re-
to provide optional blood samples. At the club visit, par- stricted to those responsible for maintenance of the ran-
ticipants will be asked to sign the PAR-Q+ screening in- domisation system. Research staff in each country will
strument that was previously administered over the not have access to randomisation codes during baseline
telephone. Men who have provided informed consent to data collection; when baseline data have been collected,
take part in the trial will be fitted with an activPAL local research staff will access the random allocation for
activity monitor to wear for the next seven days. Par- eachindividualviaastudywebportal.Datamanagement
ticipants who provide at least four days of valid data (at and statistical staff within the Clinical Trials Unit will
least 10 h per day of activPAL data) as assessed at a re- nothaveaccesstorandomisationcodespriortodatabase
turn visit to the club one week later, will be included in lock, with the exception of statistical staff providing re-
the study. They will then complete the remaining base- ports to the Independent Data Monitoring Committee;
line assessments and proceed to randomisation. Partici- these staff members will not be involved in the develop-
pants with less than four days of valid activPAL data will mentandimplementation ofthe finalstatisticalanalyses.
be asked to wear the activPAL for another 7 days or will
beexcludedfrom participationinthestudy [28]. Blinding
Participants can leave the study at any time for any Because men will know which arm of the study they are
reason and without consequences. Intervention group in, blinding is not possible. However, because random-
participants who drop out from the EuroFIT program isation occurs later, group allocation will not be known
willstillbeinvitedtoattendfollow-upmeasurement ses- toeitherparticipantsorfieldstaffatbaselineassessment.
sions as part of the trial. Participants who cannot attend The primary outcomes for the trial will be measured by
or fail to show up for their follow-up measurement ap- and downloaded directly from the activPAL, which gives
pointment at the club will be offered a home measure- an objective measurement of activity pattern that is not
ment visit or visit to the university premises to accessible to either research staff or participants until it
maximise retention to the trial. If participants wish to has been processed. The researchers who process activ-
fully withdraw from the study, their reason for leaving PALdata willbeblind togroupallocation.
the study will be obtained via a structured phone inter-
view, wherepossible. Procedures
All participants will be offered club vouchers for at- We will collect data at baseline, and at follow-up assess-
tending follow-up measurement appointments (post- ments immediately post-program and 12 months after
program follow-up: 25 euro/20 pounds/400 kroner; baseline. At six months, participants will be asked to
12 month follow-up 75 euro/60 pounds/600 kroner), as complete an additional short online questionnaire for
a gesture of thanks for their time commitment. All par- the economic evaluation. Full details of the measures are
ticipants will be offered a short feedback report after the provided below and the timing of each measurement is
12 month measures which summarises their changes on providedinTable1.
key outcomesoverthe courseofthetrial. Measurement sessionswillbeheldatthefootballclubs
during evenings, in order to maximise attendance of
Randomisation participants. All measurements will be conducted by re-
We will be using an individually randomised design, as searchers/fieldworkers trained by study staff to standar-
was used in the FFIT RCT, which confirmed that the dised protocols. Men who opt into the blood testing will
higher sample size and costs associated with a cluster have a venous blood sample taken using trained nurses/
randomised design were unwarranted as minimal con- bioengineers. Participants will be asked to complete a
taminationwasobservedbetween interventionandcom- questionnaire(eitherpaper-basedoronatabletprovided
parison group participants (the mean difference in bytheresearchteam). Sufficient staffing willbeprovided
weight loss between groups adjusted for baseline weight at measurement sessions to allow assistance to be avail-
and club was 4.9 kg [95 % CI 4.0,5.9]; a sensitivity ana- able for men with low literacy or other difficulties in
lyses adding club as a random effect adjusted for base- completing the questionnaire. In line with best practice,
line weight to account for possible clustering gave 4.9 kg country validated versions of the questionnaire will be
[95%CI3.8,6.0])[14,29]. used when available. For parts of the questionnaires
vanNassauetal.BMCPublicHealth (2016) 16:598 Page7of15
Table1SummaryofmeasuresusedintheEuroFITtrial
Baseline Post-program 6Months 12Months
Objectivephysicalactivityandsedentarytime
activPALtmmicro X X X
activPALwearingdiary(sleep,worktime) X X X
Self-reportedbehaviours
Foodintake(adaptedDINE) X X X
Physicalactivity(IPAQ-short) X X X
Domainspecificandtotalsedentarytime(Marshall) X X X
Sleepingtime X X X
Standingtime X X X
Sedentary/activebehaviours(ActivityChoiceIndex) X X X
Smoking X X X
Objectivephysicalmeasures
Bodyheight X
Bodyweight X X X
Waistcircumference X X X
Restingbloodpressure X X X
Bloodbiomarkers X X
Self-reportedhealthandpsychosocialmeasures
Wellbeing(Cantrilladder) X X X
Self-esteem(Rosenberg) X X X
Vitality X X X
QualityofLife(EQ-5D-5L) X X X
Longstandingillness,disabilityorinfirmity X X X
Jointpain X X X
Injuries X X X
Self-reportedsociodemographicmoderators
Age X
Ethnicity X
Maritalstatus X
Education X
Currentemploymentstatus X
Income X
Self-reportedmediators
Motivationforphysicalactivity(adaptedBREQ-2) X X X
Ego/Taskinvolvement X X
Clubidentification(SportSpectatorIdentificationScale) X X X
Weightmanagementstrategies X X X
Weightlossactivities X X X
Self-reportedmediators(interventiongrouponly)
Needsupportofcoach X
Needthwartingbycoach X
Mastery/performanceclimate X
Relatednesstogroup X
Needsatisfactionfromphysicalactivity X
vanNassauetal.BMCPublicHealth (2016) 16:598 Page8of15
Table1SummaryofmeasuresusedintheEuroFITtrial(Continued)
Self-reportedcost-effectiveness
Health-relatedqualityoflife(EQ-5D-5L) X X X X
Healthcareuse(iMTA) X X X
Consequencesforemployment(iPCQ) X X X
Medicationuse(iMCQ) X X
Travelcoststoclub X X X
Self-reportedprocessevaluation(interventiongrouponly)
Coaches X X
Participants X X X
lackingofficialvalidation,translationwillbedonebymem- – Offermenahome/universityvisitifthey cannot
bers of the EuroFIT research teams and back-translated attend orfailtoattend thefollow-up assessmentsat
intoEnglishbytheprincipalinvestigatorsineachcountry. the club;
– Offermenwhohavesuccessfullycompleteda
Fieldworkstafftraining follow-up assessment,aclubvoucherinappreciation
Fieldwork staff training will be standardized and quality oftheirtime.
assured.Wewillorganiseatrainingmeeting forresearch
leads from each country who will then train the field- Primaryoutcomes:objectivephysicalactivityandsedentary
workers locally. Standard operating procedures will de- time
scribe all aspects of trial delivery including specification The primary outcomes in this trial are changes in total
of equipment used in the measurement sessions and any physical activity (i.e. steps per day) and total sedentary
adaptations to survey instruments that are necessary in time (i.e. minutes per day spent sitting). This will be ob-
differentcountry/culturalsettings. jectively assessed with the activPAL activity monitor
(model activPALTM micro; PAL Technologies Ltd.,
Measurementfeasibilitystudy Glasgow, UK). The activPAL is a small monitor that
The baseline and post-program measurement protocols weighs 9 g and is taped to the front of the thigh ideally
have been tested during a feasibility study that was con- for at least seven complete consecutive days. It has no
ductedbetween September2014and February2015 in all display screen; hence the data recorded by the activPAL
four participating countries (1 club in the Netherlands, are not visible without being downloaded and processed.
Norway and UK, and 2 clubs in Portugal). In total, 57 The activPAL has been found to have good measure-
men participated in the feasibility study. Lessons learned ment properties to assess sitting, standing, stepping and
wereincorporatedintothefinalstudyprotocol. posturaltransitionsinadults[30–32].
Once consent is obtained at the information meeting,
Procedurestomaximiseretentiontothetrial trained researchers/fieldworkers will provide participants
Tomaximiseretentionatthefollow-upassessmentswewill: with face-to-face instruction on how to affix the activ-
PAL to the thigh. The face-to-face instruction will be
– Sendmenanadvance reminder thatfollow-up mea- supported by written guidance on how to fit the activ-
surementsareupcoming,usingapersonalisedletter/ PAL. Participants will be asked to wear the device 24 h
e-mailsent2–4weeksaheadofthe measurement per day (including while taking a shower) for seven con-
datesattheirclub; secutive days; they will be advised that they should only
– Phonementwoweeksbefore thescheduled post- temporarily remove the device during water submersion
programand 12monthmeasurement sessionsto activities (e.g. having a bath, swimming) and to refit the
arrange anappointmenttime forthe measurements; device as soon as possible afterwards. Participants will
– Sendaconfirmation ofthe date,timeand location be asked to keep a monitoring log to note any times
oftheman’sappointmentbye-mail/mail (according when the device was removed and replaced. Participants
tomen’sindividualpreferences); will also be asked to record work and sleep times in the
– Textmeninthedaysleadinguptotheirappointment monitoring log. At baseline, the activPAL will be
toremindthemaboutthetime,dateandlocation; returned when the participant attends the baseline
– Offermenwhodonot show upatfirst measurement session at the club. At both post-program
measurementvisita second opportunity for and 12 month follow-up assessments, participants will
measurementatthe club; receive the activPAL and written instructions by mail for
vanNassauetal.BMCPublicHealth (2016) 16:598 Page9of15
fitting and wearing the device ten days before the Objective physical measures Body height will be mea-
follow-up measurement is scheduled at their club. Each sured (to the nearest 1 mm) using a portable stadi-
participant will receive a reminder text message to re- ometer (Leicester Height Measure) at baseline only after
mindthemtowear thedevice.Maildeliveryoftheactiv- participants have removed their shoes. Body weight will
PALwassuccessfully trialled inthefeasibility study. be assessed at all measurements (to the nearest 0.1 kg)
In order to meet the inclusion criteria for the trial, as using a calibrated electronic flat scale (Tanita HD366).
described above, participants need to provide at least Participants will be allowed to wear light clothes (such
four valid days of activPAL data at baseline. Data from as shorts and t-shirts), but will be asked to remove any
the attachment and removal day will not be used for heavy items of clothing, their shoes and any items in
analyses as these are incomplete days where the partici- their pockets. We will calculate BMI as weight in kilo-
pant started or finished wearing the activPAL during the grams divided by the square of height in metres (kg/m2).
day. ActivPAL data will be considered valid when the Waist circumference will be measured twice (to the
participant wore the device for at least 10 h of the wak- nearest 0.1 cm) with a Seca 201 measure, with partici-
ingday. pants asked to remove their shirts. If the difference be-
tween the two waist measures is more than 0.5 cm, a
Secondaryoutcomes third measurement will be conducted. The mean will be
calculated fromthetwo nearest measures.
Self-reported behaviours Using an adapted version of Resting blood pressure will be measured with an
the Dietary Instrument for Nutrition Education (DINE) Omron705-CPII blood pressure monitor after5minsit-
questionnaire [33], we will assess self-reported dietary ting still. If measured systolic blood pressure is over
behaviour via the frequency of intake of the following 139 mmHg and/or measured diastolic blood pressure is
foods and drinks: cheese, burgers or sausages, beef, pork over 89 mmHg, two further measures will be taken and
or lamb, fried food, chips or French fries, bacon or ham recorded, and in line with duty of care, men will be
orpate,savourypies,pasties,sausagerollsandporkpies, given letters advising them to consult their GP. A mean
savourysnacks,consumptionoffruit,vegetables(notpo- willbe calculated from thesecondandthird measures.
tatoes), chocolate, sweets, biscuits, sugary drinks (fizzy Blood samples will be taken at baseline and after
drinks, diluting/ fruit juice) and milk. We will also assess 12 months from those who provide the additional con-
frequency of breakfast consumption and alcohol sent for this measure. Participants who have opted-in to
consumption. provide blood samples will be asked to confirm that they
Self-reported physical activity will be recorded using have fasted for at least 6 h. Time of last food/drink
the International Physical Activity Questionnaire (other than water) intake will be recorded on the elec-
(IPAQ), which assesses walking, other moderate inten- tronicCaseReportForm(eCRF).Avenousbloodsample
sity physical activity and vigorous intensity physical ac- (using 1 × 9 ml Ethylenediamine Tetraacetic Acid
tivity [34]. Self-reported sedentary time will be assessed (EDTA) tube, 1 × 7 ml Serum-separating tubes (SST),
with the Marshall questionnaire [35], which assesses and 2 × 2 ml fluoride oxalate) will be taken by a trained
total and domain specific sitting time (i.e. sitting during phlebotomist (usually a fieldwork nurse) using a stand-
transport, at work, while watching TV, while using the ard operating procedure. Samples will be stored at 4 °C
computer for leisure, and during other leisure activities). (either in a refrigerator, cool bag with ice pack or on wet
We will assess both sleeping and standing time using a ice) until processing at a local hospital, laboratory, or
single item question (How many hours in each 24 h day onsite within 24 h (ideally within 12 h) (42). Two 1 ml
do you usually spend: Sleeping (including at night and aliquots of whole blood from the EDTA tube will be dis-
naps); or Standing [36]). We will capture activity and pensed into barcoded screw-cap Eppendorf tubes. All
sedentary behaviours by using the Activity Choice Index blood tubes will then be centrifuged at 3000 rounds per
[37], measured on a 5-point scale (from ‘never’ to ‘al- minute for 20 min at 4 °C to separate red cells /plasma/
ways’).Itemsinclude:using stairs insteadofescalators or serum. The SST will be allowed to clot for at least
lifts; walking instead of driving or taking public trans- 30 min after collection before spinning. After spinning,
port; parking away from destination or getting off public 0.5 ml aliquots will be pipetted with plasma (5 from
transport early to have a longer walk; using work breaks EDTA tube, 2 from fluoride oxalate tubes) and serum (5
to be physically active; choosing to stand up instead of from SST). These will be stored in barcoded tubes at
sitting; choosing to do things by hand instead of using −80 °C in barcoded boxes in an alarmed freezer, with
mechanical/automatic tools. capability to transfer samples promptly into a spare
In addition, smoking behaviour will be assessed, in- freezer in the event of freezer breakdown. Time of sam-
cluding date of quitting and amount of current con- ple collection, start of sample processing and freezing
sumption,whenrelevant. will be recorded in the eCRF. At the end of baseline
vanNassauetal.BMCPublicHealth (2016) 16:598 Page10of15
collection for each country (except for the UK where Regulation In Exercise Questionnaire (BREQ-2) [42].
they will be delivered directly following baseline collec- This questionnaire consists of 15 statements which re-
tion at each club), all baseline samples will be shipped to quire a response on a 5-point scale (range ‘not true for
the Institute of Cardiovascular and Medical Sciences at me’ to ‘very true for me’); these assess participants’ in-
the University of Glasgow in a single consignment by trinsicmotivation,identifiedregulation,introjectedregu-
using World Courier (http://www.worldcourier.com), lation, external regulation and amotivation in relation to
where they will again be stored at −80 °C. Similarly, the exercise. Participants will also complete six items related
12-monthblood samples willbeshippedto Glasgow ina to ego/task involvement [43–45], allowing us to explore
singleconsignmentafterallthesesampleshavebeencol- participants’ motivational criteria for what it takes to
lected in each country (except for the UK, as described succeed according to their own goals. These will be used
above). in part to compare the variance between those that en-
All blood samples will be analysed at the end of the gage with the program to those who do not. The self-
trial. If analysis of the blood data shows a high risk for reported questionnaire also includes the Sport Spectator
any of the cardio-metabolic disease biomarkers that the Identification Scale which contains seven Likert-scale
participant should be aware of, we will inform the items assessing identification with a sports team (re-
participant. sponse options range from 1 (low identification) to 8
(highidentification))tomeasuremen’sdegreeofidentifi-
Self-reported health and psychosocial measures cation withtheirfootballclub [46].
Participants will be asked to complete measures of their To assess the potential contribution of other weight
self-reported health and psychosocial measures, using loss activities, we will ask participants to report if they
existing and validated measures were available. did anything else to lose weight (such as attending exer-
Wellbeing will be measured using the Cantril ladder [38]. cise workouts, attending a commercial weight loss pro-
Self-esteem will be assessed by the 10 item version of gram, having weight reduction surgery). Participants will
the Rosenberg self-esteem questionnaire [39], in which also be asked to report what sort of strategies (i.e. eating
participantsrateeachstatementona4-pointLikertscale breakfast on a daily basis, limiting quantity, restricting
(ranging from ‘strongly agree’ to ‘strongly disagree’). Vi- intake of certain foods, drinking fewer sugary drinks or
tality [40] will be measured using four statements (i.e. ‘I less alcohol and consciously eating more slowly) they
felt alive and vital’; ‘I had energy and spirit’; ‘I nearly al- use to manage their weight on a 5-point scale ranging
ways felt alert and awake’; and ‘I felt energised’) on a 7- from ‘never’ to‘always’.
point scale (ranging from ‘not at all true for me’ to ‘very We will also assess the extent to which EuroFIT
true for me’). Health-related quality of life will be mea- participants report that coaches and other group
sured using the EQ-5D-5 L [41]. This is a standardised members were able to create a needs-supportive mo-
instrument for use as a measure of health outcomes. tivational climate. Specifically, we will measure the
Participants rate their mobility, self-care, usual activities, extent to which participants report that coaches were
pain/discomfort and anxiety/depression on a 5-point able to support their autonomy, competence to make
scale. They also rate their health today on a scale from 0 changes, and feelings of relatedness, using a 5-point
to100. scale ranging from ‘not true for me’ to ‘very true for
In a face-to-face structured interview with a member me’ [47]. We will also measure ‘thwarting’ of auton-
of the fieldwork staff, participants will be asked to report omy, competence, and relatedness needs by the coach
joint pain, and any long standing illnesses, disabilities or using a 9-item measure adapted from Bartholomew et
infirmities. Injuries that occurred before and during the al. (2011) which are rated on a 7-point scale ranging
EuroFITtrialwillalsoberecordedduringthisinterview. from ‘strongly disagree’to ‘strongly agree’ [48]. In
addition, six items will assess the extent to which men
Self-reported socio demographic measures The self- feel the group climate supported mastery and perform-
reported questionnaire will assess demographic charac- ance rated on a 7-point scale ranging from ‘not at all
teristics (age, ethnicity, education, marital status, current true’ to ‘very true’ [49]. Relatedness need satisfaction
employment status, income) at baseline. These charac- from the group will be measured by 6-items adapted
teristics will be used as potential moderators of any from Van den Broeck et. al. (2010), and rated on a 7-
intervention effects on behavioural and other outcomes, point scale ranging from ‘not at all true’ to ‘very true’
to identify whether the program is more or less benefi- [50]. Finally, at 12 months only, we will ask participants
cialfor pre-specifiedsubgroupsofmen. to rate the satisfaction they experienced from engaging
in physical activity on a 6-point scale (range ‘false’ to
Self-reported mediators Motivation for physical activ- ‘true’) drawn from the adapted psychological needs sat-
ity will be assessed using the adapted Behavioural isfactioninexercisescale[51].