The effectiveness and applicability of different lifestyle interventions for enhancing wellbeing: the study design for a randomized controlled trial for persons with metabolic syndrome risk factors and psychological distress

This is an elec onic ep in o he o iginal a icle. This ep in may di e om he o iginal in pagina ion and ypog aphic de ail. Au ho (s): Ti le: Yea : Ve sion: Please ci e he o iginal e sion: All ma e ial supplied ia JYX is p o ec ed by copy igh and o he in ellec ual p ope y igh s, and duplica ion o sale o all o pa o any o he eposi o y collec ions is no pe mi ed, excep ha ma e ial may be duplica ed by you o you esea ch use o educa ional pu poses in elec onic o p in o m. You mus ob ain pe mission o any o he use. Elec onic o p in copies may no be o e ed, whe he o sale o o he wise o anyone who is no an au ho ised use . The e ec i eness and applicabili y o di e en li es yle in e en ions o enhancing wellbeing: he s udy design o a andomized con olled ial o pe sons wi h me abolic synd ome isk ac o s and psychological dis ess Lappalainen, Raimo; Sai anen, Essi; Jä elä, Elina; Ran ala, Sanni; Ko pela, Rii a; Pu onen, Sampsa; Kujala, U ho; Myllymäki, Te o; Peuhku i, Ka i; Ma ila, Elina; Kaipainen, Ki sikka; Ah inen, Aino; Ka hunen, Leila; Pihlajamäki, Jussi; Jä ne el , Heli; Lai inen, Jaana; Ku inlah i, Eija; Saa elma, Osmo; E mes, Miikka; Kolehmainen, Ma jukka Lappalainen, R., Sai anen, E., Jä elä, E., Ran ala, S., Ko pela, R., Pu onen, S., Kujala, U., Myllymäki, T., Peuhku i, K., Ma ila, E., Kaipainen, K., Ah inen, A., Ka hunen, L., Pihlajamäki, J., Jä ne el , H., Lai inen, J., Ku inlah i, E., Saa elma, O., E mes, M., & Kolehmainen, M. (2014). The e ec i eness and applicabili y o di e en li es yle in e en ions o enhancing wellbeing: he s udy design o a andomized con olled ial o pe sons wi h me abolic synd ome isk ac o s and psychological dis ess. BMC Public Heal h, 14(310). h ps://doi.o g/10.1186/1471-2458-14-310 2014 STUDY PROTOCOL Open Access The e ec i eness and applicabili y o di e en li es yle in e en ions o enhancing wellbeing: he s udy design o a andomized con olled ial o pe sons wi h me abolic synd ome isk ac o s and psychological dis ess Raimo Lappalainen 1* , Essi Sai anen 1† , Elina Jä elä 2† , Sanni Ran ala 3† , Rii a Ko pela 3 , Sampsa Pu onen 4 , U ho M Kujala 5 , Te o Myllymäki 1 , Ka i Peuhku i 3 , Elina Ma ila 6 , Ki sikka Kaipainen 6 , Aino Ah inen 6 , Leila Ka hunen 2 , Jussi Pihlajamäki 2 , Heli Jä ne el 4 , Jaana Lai inen 4 , Eija Ku inlah i 7 , Osmo Saa elma 7 , Miikka E mes 6 and Ma jukka Kolehmainen 2 Abs ac Backg ound: Obesi y and s ess a e among he mos common li es yle- ela ed heal h p oblems. Mos o he cu en disease p e en ion and managemen models a e no sa is ac o ily cos -e ec i e and ha dly each hose who need hem he mos . The e o e, no el e idence-based con olled in e en ions a e necessa y o e alua e models o p e en ion and ea men based on sel -managemen . This andomized con olled ial examines he e ec i eness, applicabili y, and accep abili y o di e en li es yle in e en ions wi h indi iduals ha ing symp oms o me abolic synd ome and psychological dis ess. The o e ed in e en ions a e based on cogni i e beha io al app oaches, and a e designed o enhancing gene al well-being and suppo ing pe sonalized li es yle changes. Me hods/Design: 339 obese indi iduals epo ing s ess symp oms we e ec ui ed and andomized o ei he (1) a minimal con ac web-guided Cogni i e Beha io al The apy-based (CBT) in e en ion including an app oach o heal h assessmen and coaching me hods, (2) a mobile-guided in e en ion comp ising o mind ulness, accep ance and alue-based exe cises, (3) a ace- o- ace g oup in e en ion using mind ulness, accep ance and alue-based app oach, o (4) a con ol g oup. The pa icipan s we e measu ed h ee imes du ing he s udy (p e = week 0, pos = week 10, and ollow-up = week 36). Psychological well-being, li es yles and habi s, ea ing beha io s, and use expe iences we e measu ed using online su eys. Labo a o y measu emen s o physical well-being and gene al heal h we e pe o med including e.g. li e unc ion, hy oid glands, kidney unc ion, blood lipids and glucose le els and body composi ion analysis. In addi ion, a 3-day ambula o y hea a e and 7-day mo emen da a we e collec ed o analyzing s ess, eco e y, physical ac i i y, and sleep pa e ns. Food in ake da a we e collec ed wi h a 48 -hou die ecall in e iew ia elephone. Di e ences in he e ec s o he in e en ions would be examined using mul iple-g oup modeling echniques, and e ec -size calcula ions. (Con inued on nex page) * Co espondence: [email p o ec ed] † Equal con ibu o s 1 Depa men o Psychology, Uni e si y o Jy äskylä, Ylis önmäen ie 33, P. O. Box 35, 40014 Jy äskylä, Finland Full lis o au ho in o ma ion is a ailable a he end o he a icle © 2014 Lappalainen e al.; licensee BioMed Cen al L d. This is an Open Access a icle dis ibu ed unde he e ms o he C ea i e Commons A ibu ion License (h p://c ea i ecommons.o g/licenses/by/4.0), which pe mi s un es ic ed use, dis ibu ion, and ep oduc ion in any medium, p o ided he o iginal wo k is p ope ly c edi ed. The C ea i e Commons Public Domain Dedica ion wai e (h p://c ea i ecommons.o g/publicdomain/ze o/1.0/) applies o he da a made a ailable in his a icle, unless o he wise s a ed. Lappalainen e al. BMC Public Heal h 2014, 14:310 h p://www.biomedcen al.com/1471-2458/14/310 (Con inued om p e ious page) Discussion: This s udy will p o ide addi ional knowledge abou he e ec s o h ee low in ensi y in e en ions o imp o ing gene al well-being among indi iduals wi h obesi y and s ess symp oms. The s udy will show e ec s o wo echnology guided sel -help in e en ions as well as e ec o an accep ance and alue–based b ie g oup in e - en ion. Those who migh bene i om he a o esaid in e en ions will inc ease knowledge base o be e unde - s and wha mechanisms acili a e e ec s o he in e en ions. T ial egis a ion: Cu en Clinical T ials NCT01738256, Regis e ed 17 Augus , 2012. Keywo ds: Li es yle, Well-being, Obesi y, S ess, Accep ance and Commi men The apy, Cogni i e beha io al he apy, Mobile applica ion, Web-based in e en ion, Technology-aided in e en ions Backg ound Obesi y is inc easing globally and is co ela ed wi h a a - ie y o heal h p oblems. Consequences o being o e weigh migh esul in he me abolic synd ome, which is a se o medical ea u es such as impai ed glucose me abolism, dyslipidaemia and hype ension ha a e isk ac o s o ca dio ascula disease and ype-II diabe es [1,2]. Li es yle changes ha e p o en o be an e icien way o coun e obes- i y and ela ed diso de s [3,4], howe e i is challenging o achie e long- e m li es yle changes using limi ed esou ces in eal-li e heal h ca e sys ems. Indi iduals ha ing p oblems ela ed o o e weigh also expe ience addi ional heal h issues such as s ess. Psycho- logical s ess is known o be ela ed wi h inc eased body mass. In addi ion psychological s ess also con ibu es o weigh gain [5-7]. The ou h Eu opean Su ey o Wo king Condi ions epo ed ha 22% o wo king Eu opean indi id- uals su e s om s ess. I is impo an o no e ha he annual inancial cos o wo k- ela ed s ess wi hin he EU was es ima ed a €20,000 million [8]. Much o exis ing heal h se ice models ha e p oblems in suppo ing long- e m li es yle changes equi ed o managing o weigh and s ess. In addi ion, exis ing disease p e en ion and managemen models a e no cos e ec i e and do no necessa ily each hose indi iduals who need hem he mos . A la ge numbe o s udies indica e ha li es yle changes could be p omo ed by using di e en ypes o In e ne -based echnologies [9-14]. A ail- able li e a u e p o ides signi ican e idence ha suppo s he e ec i eness o web-based in e en ions o li es yle and beha io al changes [15,16], howe e wha ype/s o web- based in e en ions could be bene icial o indi iduals wi h ch onic heal h diso de s is aguely epo ed and need u - he in es iga ion. In addi ion, li le is known abou he ele ance o low in ensi y p og ams using no el in e ac i e echnologies o e ing minimal con ac o hose epo ing bo h obesi y and s ess. Addi ional con olled s udies a e necessa y o e alua e di e en ypes o low in ensi y in e en ion models o p e en ion and ea men s based on sel -managemen . The e a e se e al op ions o acili a e de elopmen o low in ensi y sel -managemen app oaches o li es yle- ela ed ch onic condi ions, o example, use o In e ne - adminis a ed assessmen , online heal h sc eening and coaching app oaches based on cu en knowledge o Cogni i e Beha io al The apies (CBT). Low in ensi y CBT-based in e en ions use a minimum le el o in e - en ion essen ial o enhance men al heal h and well- being [17]. Much o he low in ensi y in e en ions use no el in e ac i e communica ion echnologies. They migh suppo long- e m li es yle changes because hey deli e swi and easy access o ea ly in e en ion and p e en i e p og ams. In addi ion o in es iga ing he e ec o low in ensi y web-based heal h sc eening and coaching applica ion, we wan ed o explo e he e ec o hi d wa e CBT me hods by applying mind ulness and accep ance-based in e en ions o indi iduals wi h obesi y and s ess. The e has been an inc easing in e es owa ds hese no el app oaches la ely wi h an aim o imp o e psychological lexibili y o p omo ing li e s yle changes. I has been p oposed ha psychological lexibili yisoneo hekey equisi es o psychological heal h [18]. Psychological lexibili y is e lec ed by how a pe son: adap s o inconsis en si - ua ions, econ igu es men al esou ces, modi ies iew- poin s, and balances compe ing desi es and needs. Fo example, in e en ions ha include componen s o psychological lexibili y ha e demons a ed signi ican bene i s when compa ed wi h con olled condi ions on measu es o dep ession and anxie y [19]. Addi ionally, he e is e idence sugges ing ha lowe psychological lexibili y and bu nou inc ease he isk o uns able emo ional s a e o mind and ad e se ea ing habi s [20]. These esul s among o he s indica e ha imp o emen o psychological lexibili y is undoub edly bene icial o indi iduals su e ing om obesi y and/o s ess. Mind ulness, accep ance and alue-based me hods a ge ing psychological lexibili y include psychological in e en ions such as Accep ance and Commi men The - apy (ACT) [21]. The e a e ew s udies ha ha e in es i- ga ed he e ec o no el mind ulness and accep ance-based in e en ions such as ACT o ch onic heal h condi ions [22,23]. An inc easing numbe o s udies indica e ha ACT is concei ably e ec i e o a wide ange o psychological Lappalainen e al. BMC Public Heal h 2014, 14:310 Page 2 o 16 h p://www.biomedcen al.com/1471-2458/14/310 and heal h diso de , such as ch onic pain, smoking, diabe es, epilepsy and wo k- ela ed s ess [24,25]. Ye u he s udies a e desi able o p o e he e ec i eness o ACT-based in e en ions such as mind ulness and accep ance p ac ices in imp o ing de e io a ed me abolic indica o s, such as dyslipidemia, low-g ade in lamma ion o de iciencies in glucose me abolism. ACT has mainly been in es iga ed using ace- o- ace in- e en ions, and he e a e only ew s udies ha ha e s udied he e ec o ACT-based app oaches o heal h diso de s using web o mobile-based in e en ions. Web-based ACT in e en ions ha e been de eloped e.g. o inni us dis ess [26], ch onic pain [27], and psychological s ess [28]. Fu - he mo e, ACT-based mobile apps ha e been s udied on small scale [29,30]. To he bes o ou knowledge, he e a e e y ew con olled ials ha ha e been conduc ed o in es iga e he e ec i eness o ACT-based mobile in e en- ions [29]. O e all, he e a e a limi ed numbe o con olled s udies ha ha e in es iga ed he e ec s and easibili y o sma phone solu ions o ch onic heal h diso de [31]. Aim and main hypo heses The o e all aim o he p esen s udy was o in es iga e he e ec o h ee no el low in ensi y psychological in e - en ions o me abolic synd ome isk ac o s, psychological lexibili y and gene al well-being among obese indi iduals expe iencing s ess. The pu pose was o s udy (a) he e ec s o minimal con ac web-based CBT in e en ion including an app oach o heal h assessmen and coaching me hods (In e ne ), (b) he e ec s o mobile-based in e en ion con- aining mind ulness, accep ance and alue-based exe cises (Mobile), and (c) he e ec s o ace- o- ace g oup in e en- ion using mind ulness, accep ance and alue-based ap- p oaches (Face- o-Face) in a con olled s udy design, whe e con ol (Con ol) ecei ed no ea men , bu he same mea- su emen s we e comple ed o all he g oups. Thus, bo h echnology-based low in ensi y sel -help in e en ions o - e ed minimal con ac , and hey we e compa ed o a b ie g oup in e en ion. Mo eo e , we we e in e es ed in s udy- ing accep abili y, applicabili y, pe cei ed bene i s, use expe- iences, and usage o he said in e en ions. The h ee in e en ions g oups, and he con ol g oup we e compa ed based on changes in li es yle measu es (e.g. ood and nu i ion in ake, meal pa e ns, physical ac i i y, sleeping habi s), psychological measu es (e.g. psychological lexibili y, pe cei ed s ess, dep ession symp oms, quali y o li e, pe cei ed quali y and quan i y o sleep), clinical and biochemical a iables (e.g. BMI, body composi ion, ci cula - ing glucose, insulin, lipids, s ess and in lamma ion indica- o s), o he physiological measu emen s (e.g. objec i e sleep measu emen s, hea a e a iabili y-based eco e y om s ess), and use expe iences (e.g. expe iences wi h he in- e en ions, ac ual usage, ealiza ion o exe cises p esen ed in in e en ions). We o mulized he ollowing hypo heses: H1: Pa icipan s who ecei e any o he h ee in e - en ions would show imp o emen s in li es yle and psychological measu es, and clinical, biochemical, and physiological a iables ascompa ed o hecon ol g oup. Each in e en ion g oup is compa ed wi h he con ol condi ion sepa a ely. H2: Pa icipan s who ecei e any o he h ee in e en- ions will show equal posi i e changes in li es yle, and psychological measu es, and clinical, biochemical, and physiological a iables when he in e en ions a e com- pa ed wi h each o he . We also wan ed o examine demog aphics and psycho- logical a iables ha could p edic change o e ime (P e, Pos and Follow-up) including age, gende , ini ial BMI, physical ac i i y, psychological lexibili y, s ess and dep essi e mood and psychological symp oms. Fu he , we would examine po en ial media o s on he e ec o he in e en ions including psychological lexibili y and mind ulness skills. Seconda y objec i es include analyses o he use expe iences and alidi y o used measu e- men and in e en ion me hods. Me hods/Design S udy design This s udy was a andomized con olled ial (RCT) (Figu e 1). Main ou come measu es we e psychological lexibili y, weigh , die quali y, ea ing beha io , pe cei ed s ess, dep ession symp oms, and sleeping habi s. Se e al o he a iables associa ed wi h li es yle changes, psycho- logical and physiological heal h was assessed du ing he s udy. We we e also in e es ed in use expe iences o he h ee no el in e en ions. The in e en ions a e desc ibed below in de ail. The s udy was pe o med a h ee ci ies in Finland (Helsinki, Jy äskylä, and Kuopio) by he local uni e si ies (Uni e si y o Helsinki, Uni e si y o Jy äskylä, and Uni e si y o Eas e n Finland, Kuopio). In addi ion, VTT Technical Resea ch Cen e o Finland (Tampe e, Finland), Finnish Ins i u e o Occupa ional Heal h (Helsinki and Oulu), and companies Duodecim Medical Publica- ionsL d.(Helsinki,Finland), Fi s bea Technologies L d. (Jy äskylä, Finland), Vi ago L d. (Espoo, Finland), Finnish Red C oss Blood Se ice (Helsinki, Finland), and Valio L d. (Helsinki, Finland) pa icipa ed in pe - o ming he s udy. The s udy was app o ed by he e hics commi ee o he Cen al Finland Heal h Ca e Dis ic , and egis e ed wi h ClinicalT ials.go wi h he iden i ie NCT01738256. The s udy was ca ied ou in wo phases. The i s phase s a ed in Sep embe 2012 and he second phase in Janua y 2013. The s udy included p e-measu emen s be o e he 8-week in e en ions, pos -measu emen s 10 weeks a e he p e-measu emen s, and ollow-up measu emen s six mon hs a e he pos measu emen s Lappalainen e al. BMC Public Heal h 2014, 14:310 Page 3 o 16 h p://www.biomedcen al.com/1471-2458/14/310 (36 weeks om p e-measu emen ). The las measu e- men s we e collec ed in Decembe 2013. S udy popula ion The ec ui ed pa icipan s (n = 339, Figu e 1) we e ei he o e weigh o obese and epo ed psychological s ess symp oms. The inclusion c i e ia we e: 1) Body Mass Index (BMI) 27–34.9 kg/m 2 , 2) pe cei ed psycho- logical s ess (a leas 3/12 poin s in Gene al Heal h Ques ionnai e [32], and 3) he possibili y o use com- pu e wi h in e ne connec ion. The exclusion c i e ia we e: diagnosed se e e ch onic illness (symp oma ic ca dio ascula disease, Type I o II diabe es, se e e psychia ic condi ions o subs ance abuse), medical su ge y wi hin he pas 6 mon hs, hea a ack/s oke wi hin pas 6 mon hs, kidney disease equi ing dialy- sis o o he disabili ies/illnesses a ec ing subs an ially physiological o men al heal h, egula use o co isone pills, pacemake , ea ing diso de (bulimia), disabili y pension o psychological easons, p egnancy o b eas - eeding wi hin he pas 6 mon hs, shi wo k (in h ee shi s) o nigh wo k, psycho he apy o o he psycho- logical o men al ea men a leas wice a mon h, and pa icipa ion in o he in e en ion s udies du ing he p esen s udy. P ocedu e o ec ui men , andomiza ion and alloca ion The pa icipan s we e ec ui ed by using ad e isemen s in local newspape s. All he pa icipan s ook pa in he s udy on olun ee basis. The ini ial exclusion c i e ia we e assessed h ough phone calls and by using elec onic ques ionnai e o epo ed dis ess. The pa icipan s who passed he ini ial sc eening we e andomly alloca ed in o one o he h ee in e en ion g oups (In e ne , Mobile, Face- o-Face), o in o a con ol g oup. A e andomiza ion, pa icipan s wi h p ede e mined abno mali ies in base- line labo a o y examina ions we e excluded om he s udy(seeFigu e1).A hebaseline isi o hes udy cen e he blood samples we e d awn o de e mining heal h s a us and excluding olun ee s wi h unknown/ undiagnosed ch onic disease o o he heal h p oblem. The measu emen s o li e , hy oid glands and kidney unc ion as well as glucose and lipid me abolism we e aken. I he e was a alue ou side e e ence alues, he pa icipan was excluded be o e s a ing he ac ual in- e en ions. W i en in o med consen was ob ained du ing he labo a o y examina ion. Randomiza ion was done by a uni e si y s a is ician using a able o an- dom numbe s (in ba ches o ou ). An independen pe son ou side o he esea ch g oup p epa ed en e- lopes con aining he andomiza ion numbe , s udy ID and g oup numbe by cen e . The en elopes we e Assessed o eligibili y (n=645) Excluded (n=306) No mee ing inclusion c i e ia Declined o pa icipa e O he easons Randomized (n=339) Los o pos in e en ion measu emen (n=3) Reasons: noncompliance (n=2), medical condi ion (n=1) Los o pos in e en ion measu emen (n=8) Reasons: noncompliance (n=5), medical condi ion (n=3) Pa icipa ed in he ollow up measu emen (n=60) Los o ollow up measu emen (n=2) Reasons: noncompliance (n=1), medical condi ion (n=1) Pa icipa ed in he ollow up measu emen (n=73) Los o ollow up measu emen (n=2) Reasons: noncompliance (n=2) Pa icipa ed in he ollow up measu emen (n=64) Los o ollow up measu emen (n=6) Reasons: noncompliance (n=4), medical condi ion (n=2) Pa icipa ed in he ollow up measu emen (n=67) Los o ollow up measu emen (n= 1) Reasons: medical condi ion (n=1) Follow up measu emen (week 36) Pos in e en ion measu emen (week 10) Los o pos in e en ion measu emen (n=2) Reasons: noncompliance (n=1), medical condi ion (n=1) Los o pos in e en ion measu emen (n=6) Reasons: noncompliance (n=6) Mobile (n=85) Recei ed alloca ed in e en ion (n=78) Did no ecei e alloca ed in e en ion (n=7): Reasons: no mee ing inclusion c i e ia (n=5), noncompliance (n=2) In e ne (n=85) Recei ed alloca ed in e en ion (n=78) Did no ecei e alloca ed in e en ion (n=7): Reasons: no mee ing inclusion c i e ia (n= 1), noncompliance (n=5), medical condi ion (n=1) Con ol (n=85) Pa icipa ed in he con ol g oup (n=70) Did no pa icipa e in he con ol g oup (n=15): Reasons: no mee ing inclusion c i e ia (n=7), noncompliance (n=7), medical condi ion (n=1) Face- o- ace (n=84) Recei ed alloca ed in e en ion (n=68) Did no ecei e alloca ed in e en ion (n=16): Reasons: no mee ing inclusion c i e ia (n=6), noncompliance (n=10) Alloca ion and p e in e en ion measu emen (week 0) Figu e 1 Flow cha o he s udy design. Lappalainen e al. BMC Public Heal h 2014, 14:310 Page 4 o 16 h p://www.biomedcen al.com/1471-2458/14/310 opened in he o de pa icipan s passed he ini ial sc eening ollowing ‘concealmen o alloca ion’p inciple. In e en ions In e ne -based coaching The In e ne -based in e en ion (Table 1) consis ed o a 12-week p og am wi hou any ace- o- ace con ac (Duodecim Vi ual Heal h Check and Coaching p o- g am). The in e en ion combined he assessmen o psychological esou ces and heal h ela ed beha io o p o ide use s wi h a comp ehensi e iew o hei heal h and li e si ua ion and ways o imp o e i . Wi h he suppo o he assessmen , he use s could choose be ween coaching p og ams o imp o e posi i e li e skills and o change heal h ela ed beha io s. In he Heal h Check, he use s illed ou a heal h ques- ionnai e assessing key heal h de e minan s, li es yle ac- o s, emo ional well-being, and pe o mance (Figu e 2). On he basis o he assessmen , he use s ecei ed es ima- ions, including a p ognosis o a e age li e expec ancy, co ona y hea disease, s oke and diabe es isk, as well as a desc ip ion o hei habi s and beha io s impac ing hei heal h (Figu e 3). The ques ionnai e and algo- i hms assessing heal h isks we e based on he Finnish heal h check and ollow-up s udy Fin iski, ha ing up o 30 yea s ollow-up da a on a popula ion sample mo e han 10 000 people [33]. On he basis o he heal h check eedback, use s could choose op ional coaching p og ams o weigh manage- men , heal hy die , exe cise, sleep imp o emen , alcohol consump ion managemen , smoking cessa ion, and men al well-being (s ess managemen , g a i ude, o gi eness, good ac ions, op imism, posi i e in e ac ion in ela ionships and esol ing con lic s in ela ionship). Pa icipan s we e none- heless commended o choose p ima ily om he ollowing h ee p og ams: S ess and li e managemen , Nu i ion, and Exe cise. The p og ams we e designed o suppo imp o e- men s in he heal h and well-being habi s and beha io s. In he coaching p og am, use s ecei ed a weekly coach- ing message including in o ma ion abou he chosen opic and a link o u he in o ma ion. In addi ion, he message con ained ad ice o exe cise, h ough which an indi idual could imp o e awa eness o his/he beha io and p ac ice skills o de elop habi s ha suppo wellbeing. The weekly message also included eedback based on en ies made by he espec i e use . The use s had an op ion o eco d ollow-up in o ma ion abou hei li es yles (weigh , phys- ical ac i i y, nu i ion, alcohol consump ion and smoking). Du ing he p og am, use s could moni o hei p og ess h ough g aphs, make new heal h checks, and choose new coaching p og ams (Figu e 4). Coaching p og ams o weigh managemen , sleep imp o emen , exe cise, alcohol consump ion manage- men , and smoking cessa ion we e based on cogni i e- beha io al p ac ices on li es yle changes [34-37]. The es and coaching p og ams o men al well-being ha e been de eloped along he ou lines desc ibed by se e al au ho s [38-40] showing ha he cogni i e beha io al coaching p og am o de elop op imism, g a i ude and o he li e skills a e e ec i e in adi ional w i ing exe cise and web-based coaching p og ams [38,41]. The alidi y o he a iables has been es ed in a la ge Table 1 Con en o he In e ne in e en ion Con en Key poin s Heal h ques ionnai e Es ima e o li e expec ancy, co ona y hea disease, s oke and diabe es isk. Desc ip ion o one’s li e habi s and beha io s impac ing on heal h and ways o in luence hem Coaching p og ams Each p og am includes a weekly message. In weigh managemen , heal hy die , exe cise, sleep imp o emen and alcohol use managemen p og ams he use has an op ion o eco d ollow-up in o ma ion abou ele an beha io o pa ame e : a) Weigh managemen Messages consis o in o ma ion, p ac ical ad ice and exe cises on weigh managemen (e.g. managing appe i e, ea ing, po ion size, buying ood), and link o u he eadings. b) Heal hy die Messages abou heal hy die and p ac ical ad ice o imp o emen , and also links o u he eadings. c) Exe cise Messages include in o ma ion abou heal h ela ed physical ac i i y and link o u he eadings. Message con ains also ad ice o p ac ice. d) S ess and li e managemen Op ional: S ess managemen , Good deeds, Op imism, Human ela ions, Social ela ions, Posi i e in e ac ion in ela ionships, Resol ing con lic s in ela ionships, Coaching exe cises o amilies wi h child en. The weekly coaching message includes in o ma ion, p ac ical ad ice, and exe cise abou s ess o li e managemen and link o u he eadings. Op ional: e) Sleep imp o emen In o ma ion, p ac ical ad ice and exe cises on good sleep (e.g. sleep hygiene, en i onmen , elaxa ion) and link o u he eadings. Message con ains also ad ice o p ac ice. ) Alcohol use managemen Cogni i e beha io al p og am o analyze easons and si ua ions o alcohol use and ad ice o a oid excess use. g) Smoking cessa ion Cogni i e beha io al p og am o analyze easons and si ua ions o smoking, men al exe cise, and suppo o qui ing. Lappalainen e al. BMC Public Heal h 2014, 14:310 Page 5 o 16 h p://www.biomedcen al.com/1471-2458/14/310 c oss-sec ional s udy whe e mo e han 130 000 Finns comple ed he ques ionnai e [42]. Mobile-based in e en ion The pa icipan s in he Mobile-based in e en ion we e in i ed in a g oup mee ing ha consis ed o a b ie o e - iew o Accep ance and Commi men The apy (ACT) p inciples. In he mee ing, he pa icipan s we e gi en And oid sma phones ha we e p e-ins alled wi h a s and-alone men al wellness aining applica ion called Oi a. They we e ins uc ed o use Oi a o he upcom- ing 8 weeks a hei own. The applica ion con ained sho exe cises ha augh ACT skills o be applied in daily li e. The mobile applica ion deli e ed an ACT- based in e en ion p og am simila o he Face- o-Face g oup. P io o he p esen ial, he applica ion had been pilo ed in a easibili y s udy wi h a sample o o ice wo ke s wi h s ess symp oms [29]. The con en o he applica ion was di ided in o ou in e en ion pa hs: Mind ul Mind, Wise Mind, Values, and Heal hy Body (Table 2). The i s h ee pa hs dem- ons a e co e p ocesses o ACT and he ou h pa h ap- plies ACT-based app oach on physical well-being. The applica ion con ained al oge he 46 exe cises in ex and audio o ma s, as well as in oduc ion ideos o each pa h and sec ion. The p og am did no include psycho- educa ion on heal hy die o physical ac i i y, only a hype link o a public nu i ional websi e was p o ided. Figu e 5 p esen s examples o he use in e ace o he applica ion. The main sc een (Figu e 5a) con ained a lowe -shaped menu h ough which di e en pa hs could be accessed. The main sc een also p o ided access o a dia y (Figu e 5b), lis o a o i e exe cises, and in oduc ion o he applica ion in ex and ideo o ma s (Figu e 5c). Each pe al ep esen s one o he pa hs, which we e num- be ed acco ding o hei ecommended o de . Each pa h consis ed o 1–4 subsec ions (“s eps”), which included 5–8 exe cises (Figu e 5d). The e was an in oduc ion in ex and ideo o ma s o each pa h and s ep, in o ming use s abou he p ocesses and skills. Mos o he exe cises we e sho and ook abou 1– 3 minu es o be comple ed (Figu e 5e-h). This aimed a making exe cises easy o pe o m in any si ua ion. Each exe cise began wi h an in oduc ion p esen ing he pu pose, du a ion and ins uc ions o he exe cise (Figu e 5e). The use s could choose o exe cise by lis ening (Figu e 5 ) o by eading (Figu e 5g). A e each exe cise, a e lec ion sc een (Figu e 5h) summa ized he skills lea ned om he exe cise andenableduse s ow i eno esand e lec ionsin hei dia y(Figu e5b).Theno eswe esa edin hedia yand could be accessed la e . The applica ion smoo hly guided use s h ough he in e en ion p og am wi hou es ic ing ee na iga ion. Pa hs, s eps, and exe cises we e numbe ed Figu e 2 Sc eensho s o he in e ne applica ion. Lappalainen e al. BMC Public Heal h 2014, 14:310 Page 6 o 16 h p://www.biomedcen al.com/1471-2458/14/310 in he ecommended o de and he nex sugges ed i em was dynamically highligh ed (Figu e 5a and d). Howe e , all pa hs and exe cises we e accessible om he e y beginning. Face- o- ace g oup in e en ion (Face- o-Face) The ACT-based ace- o- ace g oup in e en ion con- sis ed o six g oup sessions du ing 8-week pe iod o ime, wi h each session las ing o abou 90 minu es (see Table 3). Each g oup consis ed o 6–12 pa icipan s and was ins uc ed by a psychologis . Th ee psychologis s ac ed as coaches. All o hem we e ained in ACT ap- p oach, had expe ience in ACT in e en ions, and had a manual o he p og am o ollow. The pa icipan s we e gi en a wo kbook ha con ained sho desc ip ions o he sessions, exe cises, and indi idual e lec ions and no es. The in e en ion p og am aimed o suppo li es yle changes and o enhance well-being h ough commi ed and conc e e ac ions based on he pe sonally impo an alues – he mos impo an di ec ions in li e. The p o- g am s a ed wi h an analysis o own li e si ua ion and e lec ions abou alues and impo an hings in li e. A e he alue cla i ica ion, he pa icipan s made con- c e e ac ion plans and de ined hei own goals. The emphasis was placed on small and easible ac ions ha lead o be e li e acco ding o pe sonally chosen alues. In o de o achie e he se goals, he pa icipan s we e augh accep ance and mind ulness skills and new ways o deal wi h he ba ie s o ac ion. The pu pose o each- ing accep ance and mind ulness skills was o inc ease Figu e 3 Sc eensho s o he in e ne applica ion. Lappalainen e al. BMC Public Heal h 2014, 14:310 Page 7 o 16 h p://www.biomedcen al.com/1471-2458/14/310 Figu e 4 Sc eensho s o he in e ne applica ion. Table 2 Con en o he ou pa hs in he mobile in e en ion Topic o he pa h Con en Key poin s Mind ul mind Fi e mind ulness exe cises Con ac wi h he p esen momen . Focusing ully on one’s inne o ou e expe iences. Ac ing mind ully. Wise mind Obse a ion: six exe cises Obse ing hough s wi hou being caugh up in hem. Accep ance: ou exe cises Making oom o unpleasan eelings, sensa ions, u ges, and o he p i a e expe iences; allowing hem o come and go wi hou s uggling wi h hem. Values Values: se en exe cises How I use my ime in my cu en li e? How mind ulness-skills can imp o e wellbeing? Wha a e he mos impo an alues o me? Am I li ing acco ding o my alues? Value based ac ions: se en exe cises Wha a e my speci ic goals and ac ions ha suppo my alued beha io ? Heal hy body Relaxa ion: six exe cises Relaxing and lis ening o my body. Mind ul ea ing: six exe cises Exe cising mind ul ea ing. Wha is my ypical meal hy hm? Physical ac i i y: i e exe cises E e yday physical ac i i y in small s eps. Ele en gymnas ic ideo clips Lappalainen e al. BMC Public Heal h 2014, 14:310 Page 8 o 16 h p://www.biomedcen al.com/1471-2458/14/310 7. Ko wi z MU, G ebne S, Semme NK, Tschan F, El e ing A: Social s ess a wo k and change in women's body weigh . Ind Heal h 2014. 8. Milcza ek M, Schneide E, Rial González E: OSH in igu es: S ess a wo k – ac s and igu es. Eu opean Risk Obse a o y Repo . Luxembou g: O ice o O icial Publica ions o he Eu opean Communi ies: Eu opean Agency o Sa e y and Heal h a Wo k; 2009:9. 9. 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He be JD, Fo man EM: Accep ance and Mind ulness in Cogni i e Beha io The apy: Unde s anding and Applying he New The apies. Hoboken, New Je sey: John Wiley & Sons; 2011. 77. McC acken L: Mind ulness and Accep ance in Beha io al Medicine: Cu en Theo y and P ac ice. Oakland, CA: New Ha binge Publica ions; 2011. doi:10.1186/1471-2458-14-310 Ci e his a icle as: Lappalainen e al.:The e ec i eness and applicabili y o di e en li es yle in e en ions o enhancing wellbeing: he s udy design o a andomized con olled ial o pe sons wi h me abolic synd ome isk ac o s and psychological dis ess. BMC Public Heal h 2014 14:310. Submi you nex manusc ip o BioMed Cen al and ake ull ad an age o : • Con enien online submission • Tho ough pee e iew • No space cons ain s o colo figu e cha ges • Immedia e publica ion on accep ance • Inclusion in PubMed, CAS, Scopus and Google Schola • Resea ch which is eely a ailable o edis ibu ion Submi you manusc ip a www.biomedcen al.com/submi Lappalainen e al. 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