scieee Open visual document viewer

Developing Behavior Change Interventions for Self-Management in Chronic Illness: An Integrative Overview

Araújo-Soares, Vera,Hankonen, Nelli,Presseau, Justin,Rodrigues, Angela,Sniehotta, Falko F

Full text

Special Issue: Adjus men o Ch onic Illness O iginal A icles and Re iews De eloping Beha io Change In e en ions o Sel -Managemen in Ch onic Illness An In eg a i e O e iew Ve a A aújo-Soa es, 1,2 Nelli Hankonen, 3 Jus in P esseau, 4,5,6 Angela Rod igues, 1,7 and Falko F. Snieho a 1,7 1 Ins i u e o Heal h & Socie y, Facul y o Medical Sciences, Newcas le Uni e si y, Newcas le upon Tyne, UK 2 School o Psychology, Facul y o Medical Sciences, Newcas le Uni e si y, Newcas le upon Tyne, UK 3 Facul y o Social Sciences, Uni e si y o Tampe e, Finland 4 Clinical Epidemiology P og am, O awa Hospi al Resea ch Ins i u e, O awa, Canada 5 School o Epidemiology, Public Heal h and P e en i e Medicine, Uni e si y o O awa, Canada 6 School o Psychology, Uni e si y o O awa, Canada 7 Fuse. The UK Clinical Resea ch Collabo a ion Cen e o T ansla ional Resea ch in Public Heal h Abs ac : Mo e people han e e a e li ing longe wi h ch onic condi ions such as obesi y, ype 2 diabe es, and hea disease. Beha io change o e ec i e sel -managemen can imp o e heal h ou comes and quali y o li e in people li ing wi h such ch onic illnesses. The science o de eloping beha io change in e en ions wi h impac o pa ien s aims o op imize he each, e ec i eness, adop ion, implemen a ion, and main enance o in e en ions and igo ous e alua ion o ou comes and p ocesses o beha io change. The de elopmen o new se ices and echnologies o e s oppo uni ies o enhance he scope o deli e y o in e en ions o suppo beha io change and sel -managemen a scale. He ein, we e iew key con empo a y app oaches o in e en ion de elopmen , p o ide a c i ical o e iew, and in eg a e hese app oaches in o a p agma ic, use - iendly amewo k o igo ously guide decision-making in beha io change in e en ion de elopmen . Mo eo e , we highligh no el eme ging me hods o apid and agile in e en ion de elopmen . On-going p og ess in he science o in e en ion de elopmen is needed o emain in s ep wi h such new de elopmen s and o con inue o le e age beha io al science’s capaci y o con ibu e o op imizing in e en ions, modi y beha io , and acili a e sel -managemen in indi iduals li ing wi h ch onic illness. Keywo ds: Beha io change, in e en ion de elopmen , complex in e en ions Li e expec ancy con inues o inc ease wo ldwide, wi h he global a e age li e expec ancy ha ing inc eased by 5yea s be ween 2000 and 2015 (Wo ld Heal h O ganiza ion, 2014a). Howe e , non-communicable condi ions such as ca dio ascula disease, espi a o y disease, cance , and dia- be es ha e also inc eased since 2000 in e e y egion o he wo ld and a e now he mos p e alen causes o mo ali y and mo bidi y (Wo ld Heal h O ganiza ion, 2014a, 2014b). Ch onic non-communicable condi ions sha e beha io al isk ac o s such as obacco smoking, poo die , and physical inac i i y (Lim e al., 2012). These condi ions a e also associa ed wi h an inc eased isk o unde mining men al heal h (Moussa i e al., 2007). Mul imo bidi y is also p e alen and heal h beha io s can bene i pa ien s by posi i ely impac ing on mo e han one condi ion (Ba ne e al., 2012). Sel -managemen is hus a complex endea o , in ol ing adhe ence o ea men , change o mul iple heal h beha io s, and egula con ac wi h heal h- ca e p o ide s (Depa men o Heal h, 2012; Schulman- G een e al., 2012). In e en ions add essing isk ac o s and suppo ing beha io change o he e ec i e sel -managemen o ch onic condi ions can make a conside able di e ence o heal h and well-being and educe he cos s o deli e ing heal h ca e o an aging popula ion li ing longe wi h ch onic condi ions (OECD/EU, 2016). In he US, 157 mil- lion people a e p edic ed o li e wi h ch onic condi ions by 2020. Popula ion aging aises capaci y conce ns o heal hca e sys ems, in hei cu en con igu a ions, o cope wi h he inc easing bu den o ch onic condi ions Ó2018 Hog e e Publishing. Dis ibu ed as a Hog e e OpenMind a icle Eu opean Psychologis (2019), 24(1), 7–25 unde he license [CC BY 4.0 (h p://c ea i ecommons.o g/licenses/by/4.0/)] h ps://doi.o g/10.1027/1016-9040/a000330 ${p o ocol}://econ en .hog e e.com/doi/pd /10.1027/1016-9040/a000330 - F iday, Feb ua y 15, 2019 12:57:09 AM - IP Add ess:153.1.49.17 (Bodenheime , Chen, & Benne , 2009; NHS England, 2016). The e is consensus o he need o in e en ions o suppo indi iduals and popula ions by a ge ing he p e- en ion and sel -managemen o ch onic disease (Boon e al., 2014) and o he key ole o beha io change in e - en ions in his p ocess (Ha deman, Su on, Michie, & Kin- mon h, 2004). Wha Is a Heal h Beha io Change In e en ion? In e en ions a e coo dina ed se s o ac i i ies and ech- niques in oduced a a gi en ime and place o change he beha io o indi iduals, communi ies, and/o popula- ions h ough a hypo hesized o known mechanism (NICE, 2007,2014). The heal h o popula ions and he indi iduals wi hin hem is in luenced by a complex sys em o de e mi- nan s, om indi idual li es yle ac o o communi y in lu- ences, h ough li ing, wo king, and social condi ions (Dahlg en & Whi ehead, 2006). Heal h beha io change in e en ions can be a ge ed a a combina ion o le els: policy (e.g., laws and egula ion), communi y (e.g., neigh- bo hoods), mac o-en i onmen s (e.g., oo ou le s o ans- po links), mic o-en i onmen al (e.g., choice a chi ec u e in shops), ins i u ional (e.g., schools and employe s), in e - pe sonal ( amilies and social ne wo ks), and/o in ape - sonal (e.g., weigh loss p og am o he apy) le el (A aújo- Soa es & Snieho a, 2017; Hollands e al., 2017;McLe oy, Bibeau, S eckle , & Glanz, 1988). Heal h beha io change in e en ions a e usually com- plex (C aig e al., 2008). Wha makes an in e en ion com- plex is he numbe and complexi y o i s in e ac ing componen s, he beha io s in ol ed, he o ganiza ional g oup, and indi idual le els a ge ed and he ou comes as well as he deg ee o lexibili y o ailo ing pe mi ed. The TIDieR checklis (Ho mann e al., 2014) was de eloped o imp o e he comple eness o epo ing, and ul ima ely he eplicabili y, o in e en ions by desc ibing: (a) a a io- nale o heo y desc ibing he goals o he in e en ion ele- men s, (b) he con en in e ms o beha io change me hods (Adams, Giles, McColl, & Snieho a, 2014;Hol- lands e al., 2017; Kok e al., 2016; Michie, Richa dson, Johns on, Ab aham, F ancis, Ha deman, e al., 2013), ma e- ials, and p ocedu es, (c) p o ide (s) (including quali ica ion and aining needed), (d) modes o deli e y (e.g., p o ided ace- o- ace o h ough a digi al pla o m) o indi iduals o g oups (Domb owski, O’Ca oll, & Williams, 2016), (e) loca ion and equi ed in as uc u e, ( ) iming and dose, and (g) any planned mechanisms o ailo ing o adap a ion o he in e en ion o needs/ ea u es o he ecipien (s). An ex ension o he TIDieR guideline o epo ing popula ion heal h and policy in e en ions has ecen ly been published (Campbell e al., 2018). In e en ions also o en include addi ional componen s o build and sus ain appo and engagemen h ough in e pe sonal s yles (Hagge & Ha d- cas le, 2014) o ea u es such as gami ica ion in digi al in e en ions (Cugelman, 2013). Heal h beha io change in e en ion de elopmen is he p ocess o deciding he op imal combina ion o hese ea u es and he anspa en epo ing o hese decisions. Wha Makes a Good Heal h Beha io Change In e en ion? “P imum non noce e”(eng. “ i s , do no ha m”). The p in- ciple o non-male icence is he single mos impo an c i e- ion o any heal h in e en ion (C aig e al., 2008;Michie, A kins, & Wes , 2014). In addi ion, a good in e en ion should be designed o impac , should be e aluable, should no inc ease social inequali ies, and should ha e a demon- s able bene i o e exis ing in e en ions and se ices. The impac o in e en ions on he heal h o he a ge audience can be illus a ed h ough he RE-AIM (Reach, E ec i eness, Adop ion, Implemen a ion, Main enance) model (Glasgow, Vog , & Boles, 1999). Reach e e s o he p opo ion o he in ended a ge popula ion ha can ac ually be and is ul ima ely eached wi h an in e en ion; E ec i eness e e s o he bene icial and unin ended e ec he in e en ion achie es on key ou comes unde eal- wo ld condi ions, including cos -e ec i eness; Adop ion e e s o he up ake o he in e en ion by he s a , se ings, and o ganiza ions; Implemen a ion e e s o he deg ee o which he in e en ion can/will be deli e ed consis en ly and wi h ideli y o e ime and se ing; and Main enance e e s o he sus ainabili y o in e en ion e ec i eness in indi iduals and se ings o e ime. To achie e his, in e - en ions should be based on he bes a ailable e idence- based heo y and di ec e idence o op imize impac and o model whe he and how he in e en ion is likely o c e- a e bene i (Ba holomew Eld edge e al., 2016;C aige al., 2008;Wigh ,Wimbush,Jepson,&Doi,2016). Op imizing RE-AIM is aided by maximizing he accep abili y and easi- bili y o in e en ion p ocedu es and ma e ials (Lancas e , 2015). This is bes achie ed h ough he ac i e in ol emen o key s akeholde s in all s ages, om de elopmen h ough o e alua ion o accep abili y and easibili y in ini ial pilo / easibili y s udies as well as subsequen e icacy/e ec i e- ness, implemen a ion and main enance e alua ions (C aig e al., 2008;O’B ien e al., 2016). A p e equisi e o a good in e en ion is i s “e aluabili y,” ha is, whe he i s e ec can be obus ly e alua ed. In e - en ions wi h a clea de ini ion, elabo a ed logic model, Eu opean Psychologis (2019), 24(1), 7–25 Ó2018 Hog e e Publishing. Dis ibu ed as a Hog e e OpenMind a icle unde he license [CC BY 4.0 (h p://c ea i ecommons.o g/licenses/by/4.0/)] 8 V. A aújo-Soa es e al., Me hods o In e en ion De elopmen ${p o ocol}://econ en .hog e e.com/doi/pd /10.1027/1016-9040/a000330 - F iday, Feb ua y 15, 2019 12:57:09 AM - IP Add ess:153.1.49.17 and de ined p ima y and in e media e a ge s a e easie o e alua e, which in u n acili a e unde s anding i , how and o whom an in e en ion wo ks, acili a ing op imiza ion and he eby con ibu ing o he accumula ion o knowledge (Le i on, Khan, Rog, Dawkins, & Co on, 2010; Ogil ie e al., 2011; Windso , 2015). Good in e en ions should no inc ease social inequali- ies in heal h (Lo enc, Pe ic ew, Welch, & Tugwell, 2013). Heal h and heal hy li e expec ancy a e s ongly ela ed o socioeconomic s a us (OECD/EU, 2016). To a oid in e en ion-gene a ed inequali ies, in e en ion design should be sensi i e o PROGRESS indica o s (Place o esidence, Race/e hnici y/cul u e/language, Occupa ion, Gende /sex, Religion, Educa ion, Socioeconomic s a us, and Social capi al (T. E ans & B own, 2003;O’Neill e al., 2014). In e en ion de elope s need o conside up ake, usage, and le el o indi idual agency equi ed o minimize he po en ial o gene a ing inequali ies (Adams, My on, Whi e, & Monsi ais, 2016). Finally, good in e en ions should c ea e inc emen al bene i o e al eady exis ing in e en ions and se ices. In e en ions ha e high u ili y i hey add ess gaps in p o i- sion, inc ease he po en ial o be implemen ed and sus- ained, educe cos s and/o add ess ba ie s compa ed wi h p e ious and exis ing in e en ions. In pa icula , scal- able in e en ions, ha is, e ec i e in e en ions which ha e a a each and modes cos s, add ess he need o solu ions which ha e ew esou ce and geog aphic ba ie s and can be p o ided o la ge numbe s o indi iduals and communi ies (Mila , King, Bauman, & Redman, 2013). The heal h esea ch landscape is no sho o beha io al in e en ions. In ligh o his, a ho ough en i onmen al scan analysis is needed o iden i y gaps in p o ision o ensu e ha new in e en ions ha e a ai chance o make a posi i e con ibu ion o heal h and well-being. Unde - s anding usual ca e and compe ing in e en ions in a gi en se ing enables s a egic decision-making abou po en ial inc emen al bene i o a new in e en ion. Inc easingly, he bounda ies o usual ca e a e no longe physical o geo- g aphical. As in e en ions can ake yea s o be de eloped and ully e alua ed, his analysis o he heal h in e en ion ma ke should also conside pilo s udies and e alua ion s udies unde way, o example, by analyzing ial egis ies and g ey li e a u e (Adams, Hillie -B own, e al., 2016). The P ocess o In e en ion De elopmen The e is a ange o amewo ks ha can in o m he de el- opmen o heal h beha io change in e en ions such as he MRC guidance o he de elopmen and e alua ion o complex in e en ions (C aig e al., 2008), In e en ion mapping (IM; Ba holomew Eld edge e al., 2016), Theo y In o med Implemen a ion In e en ion (S. D. F ench e al., 2012), PRECEDE-PROCEDE (G een & K eu e , 2005), he Pe son-Based App oach (Ya dley, Mo ison, B adbu y, & Mulle , 2015), he 6SQuID app oach in quali y in e en ionde elopmen (Wigh e al.,2016), e idence- guided co-design (O’B ien e al., 2016), he Knowledge- o-Ac ion (KTA) cycle (G aham e al., 2006), he ORBIT model (Czajkowski e al., 2015), he Expe imen al Medicine Model (Shee an, Klein, & Ro hman, 2017), Mul iphase op i- miza ion s a egy (MOST; Collins, Mu phy, & S eche , 2007), and he Beha io Change Wheel (Michie, an S a- len, & Wes , 2011; see Appendix A o a summa y o ame- wo ks and hei pu pose). While each has a di e en ocus and app oach, hey con e ge on a co e se o key s eps ha include: analyzing he p oblem and de eloping an in e en- ion objec i e, causal modeling, de ining in e en ion ea- u es, de eloping a logic model o change, de eloping ma e ials and in e ace, and empi ical op imiza ion ol- lowed by ou come and p ocess e alua ion and implemen a- ion. In e en ion de elopmen is i e a i e, ecu si e, and cyclical a he han linea . De elope s may need o go back and o h be ween s eps o achie e he op imal in e en ion de ini ion pai ed wi h mos app op ia e logic model o change wi hin a ailable esou ces. In e en ion de elopmen should ideally be led by an in e disciplina y Planning and De elopmen G oup ep e- sen ing ele an expe ise (e.g., clinical ca e, psychology, policy, sociology, heal h economics, epidemiology, se ice design) and key s akeholde s (e.g., ci izens, pa ien s, ca e s, heal hca e p o essionals, deli e e s, commissione s, policy- make s, unde s) o unde s and he con ex o in e ening and o make s a egic decisions ha e lec scien i ic e i- dence and he p e e ences and iews o hose o whom he in e en ion is de eloped and hose whose inpu is needed o adop and implemen he in e en ion (Ba holo- mew Eld edge e al., 2016;Wi emane al.,2017). To docu- men he sequence o decisions in ol ed in in e en ion de elopmen , wo kbooks can help o eco d in e en ion de elopmen s eps, c ucial decisions, and he p ocess and in o ma ion in o ming hese decisions (Ba holomew Eld edge e al., 2016); Appendix B con ains a comp ehen- si e lis o Key Conside a ions o he Repo ing o In e - en ion De elopmen ). Nex , we add ess each key s ep in de ail: A. Analyzing he P oblem and De eloping an In e en ion Objec i e The de elopmen o a beha io change in e en ion es s on a ounda ion o a ho ough analysis o he p oblem ha Ó2018 Hog e e Publishing. Dis ibu ed as a Hog e e OpenMind a icle Eu opean Psychologis (2019), 24(1), 7–25 unde he license [CC BY 4.0 (h p://c ea i ecommons.o g/licenses/by/4.0/)] V. A aújo-Soa es e al., Me hods o In e en ion De elopmen 9 ${p o ocol}://econ en .hog e e.com/doi/pd /10.1027/1016-9040/a000330 - F iday, Feb ua y 15, 2019 12:57:09 AM - IP Add ess:153.1.49.17 he in e en ion de elope s aim o sol e and a clea de ini- ion o in e en ion objec i es. PRECEDE/PROCEED was concei edin he1970s o guide policymake s and in e en- ion planne s in analyzing he likely cos s and bene i s o heal h p og ams. I consis s o wo main pa s: PRECEDE desc ibes an “educa ional diagnosis”and is an ac onym o P edisposing, Rein o cing and Enabling Cons uc s in Educa ional Diagnosis and E alua ion. PROCEED e e s o an “ecological diagnosis”and s ands o Policy, Regula- o y, and O ganiza ional Cons uc s in Educa ional and En i onmen al De elopmen (G een & K eu e , 2005). I p o ides he i s amewo k o analyzing how heal h and quali y o li e ela e o beha io , physiology, and en i on- men al ac o s and o he iden i ica ion o p edisposing, ein o cing, and enabling ac o s o beha io s, which can be ackled wi h in e en ions. Many in e en ion de elopmen amewo ks include a Needs Assessmen , which in ol es assessing he heal h p oblem and i s likely beha io al, social, and en i onmen al causes. This ini ial s age in ol es he iden i ica ion and de - ini ion o he sequence o beha io s needed o modi y heal h ou comes he eby iden i ying in e media e ou comes ele an o he hypo hesized mechanisms o he in e en- ion (Ba holomew Eld edge e al., 2016), ha is, “who needs o do wha di e en ly, when, whe e, how?”(S. D. F ench e al., 2012). The pe son-based app oach o in e - en ion de elopmen (Ya dley e al., 2015)aims og ound he de elopmen o beha io change in e en ions in an unde s anding o he pe spec i e and psychosocial con ex o he people who will use hem. Beha io s a ge ed o change a e embedded in a ne wo k o mul iple beha io s, some o which may acili a e o con lic wi h each o he (P esseau, Tai , Johns on, F ancis, & Snieho a, 2013). Unde s anding how a a ge heal h beha io i s alongside o he beha io s, and he essen ial p epa a o y beha io s equi ed, can help o iden i y he mos iable beha io al a - ge s o an in e en ion ha may ex end beyond he single beha io al ou come o he in e en ion. Ta ge beha io s need o be de ined in con ex and in e y speci ic e ms, ideally in e ms o Ta ge (s), Ac ion, Con ex (s), Time(s) and ac o s (Fishbein, 1967; F ancis & P esseau, 2018), including he in e - ela ionships be ween beha io s and ac o s. Conside a ions abou changeabili y guide he p io - i iza ion and selec ion o a ge beha io s and a ge ed an eceden s o beha io , o example, which changes a e achie able based on cu en e idence and heo y, and how much impac would such changes ha e o he key ou - comes (Ba holomew Eld edge e al., 2016;Czajkowski e al., 2015; Shee an e al., 2017; Wigh e al., 2016). Key s akeholde s should con ibu e om he beginning o de ining he ini ial p oblem, a he han he in e en ion de elopmen being a esea che -d i en op-down design ask. S akeholde in ol emen helps o b idge be ween he e idence and he local con ex and ensu es owne ship, accep abili y, and widesp ead suppo o he in e en ion essen ial o implemen a ion (O’B ien e al., 2016). In some ins ances, in e en ion p io i ies a e d i en by use s o pa ien o ganiza ion. Such p io i ies can be obus ly su - aced, o example, in ol ing James Lind Alliance (2017) me hods ha b ing clinicians, pa ien s, and ca e s oge he o use a o mal me hodological app oach o gene a e esea ch p io i ies ha a e impo an o pa ien s ac oss a ange o se ings. B. De ining he Scien i ic Co e o he In e en ion Heal h beha io change in e en ions a e guided by a logic model o a heo y o change ha combines he in e en ion echniques used o a ge causal mechanisms in o a com- p ehensi e and es able se o assump ions (Moo e e al., 2015). Th ee s eps go hand in hand and a e bes desc ibed as one i e a i e p ocess:(i) causal modeling o he p oblem, (ii) de ining in e en ion ea u es, and (iii) o mula ing a logic model o change o he in e en ion (Ba holomew Eld edge e al., 2016; Moo e e al., 2015; Wigh e al., 2016). Decisions need o be made on me hod(s) and mode(s) o deli e y, beha io change echnique(s), p o ide (s), loca ion (s), iming, dose, pe sonaliza ion and hypo hesized causal mechanisms o op imize each, (cos -) e ec i eness, adop- ion, implemen a ion, and main enance. These design deci- sions should be eco ded and made explici o cla i y he con ibu ion ha all new in e en ions make o p e ious e idence. The p ocess should be led by a pa icipa o y plan- ning g oup ep esen ing s akeholde s such as use s and commissione s o he in e en ion and he esea ch eam o i e a i ely build a hypo hesis o change and make design decisions based on scien i ic e idence and he needs o he a ge audience. This ensu es he ele ance o he de el- oped solu ion and c ea es co-owne ship as a esul o cop oduc ion. (i) Causal Modeling The iden i ica ion o causal and con ex ual ac o s a ec ing sel -managemen beha io s is a key s ep in in e en ion de elopmen . Beha io is he esul o a complex ecologic sys em o in luences which ange om p oximal indi idual, cogni i e, and emo ional ac o s o social and communi y in luence up o mo e dis al ac o s such as ca e deli e y sys- ems (e.g., access o specialis medical ca e), li ing and wo king condi ions (employmen , en i onmen , educa ion, and housing), and socioeconomic, cul u al, and en i on- men al condi ions (e.g., legisla ion; Dahlg en & Whi ehead, 2006). Modi iable ac o s ha ha e a s ong ela ionship o Eu opean Psychologis (2019), 24(1), 7–25 Ó2018 Hog e e Publishing. Dis ibu ed as a Hog e e OpenMind a icle unde he license [CC BY 4.0 (h p://c ea i ecommons.o g/licenses/by/4.0/)] 10 V. A aújo-Soa es e al., Me hods o In e en ion De elopmen ${p o ocol}://econ en .hog e e.com/doi/pd /10.1027/1016-9040/a000330 - F iday, Feb ua y 15, 2019 12:57:09 AM - IP Add ess:153.1.49.17 he a ge beha io a e po en ial a ge s o in e en ions (Michie, an S alen, e al., 2011; Wigh e al., 2016). Beha io change app oaches end o ope a e on he assump ion ha in e en ions a ec beha io by modi ying social, en i onmen al, and/o cogni i e p edic o s o he a ge beha io . In e en ions a e hen hough o ope a e h ough a sequen ial causal model beginning om p edic- o s o beha io , o beha io , o physiological changes and e en ually leading o heal h ou come(s) (Ha deman e al., 2005). IM (Ba holomew Eld edge e al., 2016) p oposes o wo k backwa d om he a ge ed heal h p oblems (and ha impac on quali y o li e), o he beha io and en i on- men al ac o s ha shape hese heal h p oblems, and inally o he p edic o s o he causal beha io al and en i onmen- al isk ac o s. P edic o s a e a ed by ele ance and changeabili y o de e mine hei p io i y o inclusion in he in e en ion (Ba holomew Eld edge e al., 2016;Ya d- ley e al., 2015). Li e a u e e iews a e ecommended o syn hesize e i- dence o he causes and p edic o s o he a ge beha io (Ba holomew Eld edge e al., 2016;C aige al.,2008), ide- ally, wi h sys ema ic sea ches (C aig e al 2008). In e iew- ing exis ing e idence, ensions be ween s eng h and igo and applicabili y o e idence can occu . Decisions abou e idence e iews should be s a egically d i en o add ess key unce ain ies. While usually sys ema ic e iews o s ud- ies wi h low isk o bias a e p e e able, he mos ele an e idence in o ming an in e en ion migh be supplemen ed by g ey li e a u e such as local go e nmen epo s o hos- pi al eco ds (Adams, Hillie -B own, e al., 2016;O’B ien e al., 2016;Rod igues,Snieho a,Bi ch-Machin,Oli ie , &A aujo-Soa es,2017). Re iews may highligh he deg ee o which esul s a e likely o be ans e able o he p esen con ex bu o en addi ional empi ical esea ch is needed o iden i y he mos impo an p edic o s and o es hei sen- si i i y o con ex ual ea u es o communi ies, se ices, o geog aphies. Theo y has a cen al ole in his p ocess. In e en- ion de elopmen is o en based on ope a ionalizing he p inciples om a single heo y and selec ing in e en ion echniques wi h he po en ial o modi y he heo e ical p e- dic o s o beha io . This app oach can be use ul when he e is insu icien esou ce o conside collec ing u he empi ical da a and gi en he inhe en ly e idenced-based na u e o a heo y, in ha i has been success ully applied o di e en beha io s and/o in di e en con ex s (D. P. F ench, Da ke , E es, & Snieho a, 2013). Howe e , his app oach is limi ed when he obse ed p ospec i e ela ionships conside ed o he selec ion o in e medi- a e in e en ion a ge s a e no s ong enough o in e - en ions changing beha io al p edic o s o achie e changes in beha io (Snieho a, P esseau, & A aújo-Soa es, 2014). When no app op ia e heo y can be iden i ied, o when mo e han one may seem ele an , in e en ion de elope s can use he Theo e ical Domains F amewo k (TDF) o o ganize e idence abou key ba ie s and enable s and link back o ele an heo ies (F ancis, O’Conno , & Cu an, 2012; Heslehu s e al., 2014).TheTDFisasimple ool de eloped h ough e iew and consensus me hods o desc ibe he mos common explana o y cons uc s in beha io al heo ies o ganized in o 14 domains: knowledge, skills, social in luences, memo y, a en ion and decision p ocesses, social/p o essional ole and iden i y, ein o ce- men , belie s abou capabili ies, belie s abou conse- quences, op imism, in en ion, goals, beha io al egula ion, emo ion, en i onmen al con ex and esou ces (Cane, O’Conno , & Michie, 2012; Michie e al., 2005). The TDF can be used o in o m bo h quali a i e and quan i a i e s udies wi h he aim o unde s and key p edic o s o beha - io and o iden i y he mos ele an heo e ical app oach (Beens ock e al., 2012; Laine, A aújo-Soa es, Haukkala, & Hankonen, 2017; P esseau, Schwalm, e al., 2017). Addi ional empi ical s udies can inc ease unde s anding o he key in luences o he beha io in he a ge g oup. Fo example, a su ey iden i ying he mos impo an co e- la es o physical ac i i y beha io and in en ion could help in selec ing he key ba ie s and enable s o a ge wi h an in e en ion (Hankonen, Heino, Kujala, e al., 2017; P esseau,Schwalm,e al.,2017; Snieho a, Schwa ze , Scholz, & Schüz, 2005). Quali a i e in e iews o n-o -1 s udies can p o ide an indi idualized assessmen o ba ie s and needs (McDonald e al., 2017; Rod igues, Snieho a, Bi ch-Machin, & A aujo-Soa es, 2017; Ya dley e al., 2015). A key weakness o app oaches based on co ela ion is he lack o causa ion and he p oblem o a enua ion, ha is, la ge changes in p edic o s a e needed o achie e mod- es changes in beha io (Snieho a, 2009). Whe e mul iple beha io s a e a ge ed, a p ocess o es - ing mul iple heo ies ac oss mul iple beha io s can be used o iden i y he mos consis en ly p edic i e cons uc s wi hin hei heo ies ac oss beha io s, hen heo ize and es how such heo ies and hei cons uc s can be com- bined, o example, in o a dual p ocess model (P esseau, Johns on, e al., 2014) o in o m a logic model (P esseau, Haw ho ne, e al., 2014). This app oach combines he s eng h o p eexis ing heo y (and i s es ed media ing and mode a ing mechanisms) wi h he empi ical compa - ison o heo y ac oss beha io s o acili a e he selec ion o beha io (s) and heo y upon which o u he de elop he in e en ion. Theo y is used o add ess unce ain ies and may include heo e ical ideas ha a e no di ec ly ela ed o beha io , o example, heo ies o pe suasion (Pe y & Cacioppo, 1986) o o symp om ecogni ion (Pe e - sen, an den Be g, Janssens, & an den Be gh, 2011). Fig- u e 1p o ides wo examples o in e en ion de elopmen . Ó2018 Hog e e Publishing. Dis ibu ed as a Hog e e OpenMind a icle Eu opean Psychologis (2019), 24(1), 7–25 unde he license [CC BY 4.0 (h p://c ea i ecommons.o g/licenses/by/4.0/)] V. A aújo-Soa es e al., Me hods o In e en ion De elopmen 11 ${p o ocol}://econ en .hog e e.com/doi/pd /10.1027/1016-9040/a000330 - F iday, Feb ua y 15, 2019 12:57:09 AM - IP Add ess:153.1.49.17 (ii) De ining In e en ion Fea u es In e en ion echniques (e.g., o change beha io , cogni- ions, pe cep ions, o en i onmen al a iables) a e selec ed based on e idence o hei e ec i eness in changing he iden i ied causal and con ex ual ac o s in luencing he a - ge beha io . In e en ion de elopmen app oaches di e in how hey app oach he analysis o causal ac o s ocuss- ing on in e en ion a ge s o echniques (Michie e al., 2014; Shee an e al., 2017;Webb,Michie,&Snieho a, 2010). Ta ge -based app oaches iden i y modi iable p edic- o s o beha io , whe eas echnique-based app oaches ocus on in e en ion echniques hemsel es and con ex ual modi ica ions which di ec ly in luence beha io (Webb e al., 2010). As highligh ed in he knowledge c ea ion unnel wi hin he KTA cycle (G aham e al., 2006), use o e iew e i- dence se s he ounda ion and p e en s epea ing p e i- ously unsuccess ul beha io change echniques o wi hholding in e en ion s a egies wi h demons a ed e ec i eness in changing beha io . In some cases, e idence syn hesis may iden i y ha a sui able in e en ion al eady exis s ha could be e o i ed (i.e., ans o med o use in a no el con ex and o in a no el popula ion) a he han e-in en ed. Bu sys ema ic e iews o andomised con- olled ials (RCTs) o in e en ions wi h simila aims do no always p o ide su icien answe s. Fo example, in he de elopmen o he “Le ’sMo eI ”in e en ion o change physical ac i i y and seden a y beha io s in oca ional school, a sys ema ic e iew (Hynynen e al., 2016)in o med he designe s abou wha wo ks in ge ing olde adolescen s mo e ac i e, bu i was no su icien . A ange o o he el- e an sou ces o e idence con ibu ed o i s de elopmen including exis ing e idence ega ding he se ing (school- based heal h p omo ion), e idence abou he a ge beha - io using a ange o me hods and esea ch on simila in e - en ions in o he age g oups and popula ions con ibu ed o in o m he in e en ion design. Di e en le els o e idence answe di e en ques ions. While sys ema ic e iews o RCTs o beha io change in e - en ions p o ide he s onges e idence o e ec i eness, hey o en say li le abou each, adop ion, and implemen a- ion ou side o a esea ch s udy o abou longe - e m main- enance (Domb owski e al., 2012). Likewise e idence om igo ous s udies conduc ed in e y di e en se ings o in communi ies wi h di e en ea u es may be applicable o he local needs when e o i ed. E idence syn hesis should be s a egic and sequen ial, de eloping an i e a i e unde - s anding o how o op imize he in e en ion (Michie e al., 2014). Whe e p e ious heal h beha io change in e - en ions had he e ogeneous e ec s, i is o en possible o code beha io change echniques and o he in e en ion ea u es such as modes o deli e y (Ab aham & Michie, 2008; Adams e al., 2014;Koke al.,2016;Michie,Ash o d, e al., 2011; Michie, Richa dson, Johns on, Ab aham, F an- cis, & Ha deman, 2013) and o explo e whe he such ea- u es a e associa ed wi h in e en ion e ec i eness (Domb owski e al., 2012). Such an in e en ion ea u es e iew-based app oach begins by iden i ying in e en ion echniques and o he TIDIER ea u es (Ho mann e al., 2014) o in e en ions o a gi en heal h beha io in a sys- ema ic e iew o ials. TIDIER ea u es, including beha - io change echniques and o he in e en ion echniques can hen be coded wi hin in e en ions in he e iew o es which echniques and combina ions o hese a e associa ed wi h g ea e e ec i eness in o he se ings. E en hough i- als o in e en ions make causal s a emen s o e ec i e- ness, he e alua ion o in e en ion echniques wi hin he e iew is co ela ional and should be ea ed wi h due ca e. Ne e heless, his app oach can help o combine e idence o in e en ion s a egies ha ha e been ound o be e ec- i e in o he se ings and/o using heo y o in o m he selec ion o in e en ion echniques. In addi ion o e iew-based iden i ica ion o e ec i e in e en ion ea u es, some app oaches p omo e an expe i- men al me hod o in e en ion de elopmen o es ablish causal e idence o he hypo hesized change by iden i ying he po en ial modi iable causal ac o s and assessing whe he changes in he a ge beha io occu as a esul o manipula ing he p edic i e ac o (s) (Shee an e al., 2017). The emphasis is on unde s anding he mechanisms o change and using expe imen al designs o obus ly cla i y how o change hese and in eg a ing his knowledge in o applied esea ch. En i onmen al in e en ions a ge ing poin -o -choice decisions such as s ai s e sus escala o use(Ryan,Lyon,Webb,E es,&Ryan,2011) and on- he- spo oppo uni ies o egis e o o gan dona ion (Li e al., 2017), nudges (Hollands e al., 2013; Ma eau, Ogil ie, Roland, Suh cke, & Kelly, 2011) o poin o sale decisions (Dolan e al., 2012) a e mo e likely o be in o med by expe - imen al han by co ela ional conside a ions. Some in e en ion echniques may be e ec i e when es ed in an RCT bu no widely accep able by acili a o s o a ge audience alike, while o he in e en ion ech- niques migh be highly accep able bu show smalle e ec sizes. Accep abili y can be de ined as a “mul i- ace ed con- s uc ha e lec s he ex en o which people deli e ing o ecei ing a heal hca e in e en ion conside i o be app o- p ia e, based on an icipa ed o expe ienced cogni i e and emo ional esponses o he in e en ion”(Sekhon, Ca - w igh , & F ancis, 2017,p.4). Engaging s akeholde s in he de elopmen p ocess om ea ly on will inc ease he po en ial o accep abili y. In e en ion p inciples ha a e heo e ically sound and in line wi h good e idence, migh s ill no be seen as accep able wi hou adap a ion o con ex and audience. Fo example, some migh no be willing o engage in planning in e en ions unless key modi ica ions Eu opean Psychologis (2019), 24(1), 7–25 Ó2018 Hog e e Publishing. Dis ibu ed as a Hog e e OpenMind a icle unde he license [CC BY 4.0 (h p://c ea i ecommons.o g/licenses/by/4.0/)] 12 V. A aújo-Soa es e al., Me hods o In e en ion De elopmen ${p o ocol}://econ en .hog e e.com/doi/pd /10.1027/1016-9040/a000330 - F iday, Feb ua y 15, 2019 12:57:09 AM - IP Add ess:153.1.49.17 a e implemen ed o inc ease accep abili y and easibili y (Wi eman e al., 2017). An icipa ed accep abili y o candi- da e ea u es can be empi ically examined o in o m deci- sions, o example, eache s’ iews on po en ial s a egies o educe s uden si ing in schools was examined using a mixed-me hods app oach (Laine e al., 2017). This example also illus a es ha in addi ion o he main a ge g oup (s u- den s), he en i onmen al agen s o “p o ide s”( eache s) The In e en ions Suppo ing Long- e m Adhe ence and Dec easing ca dio ascula e en s (ISLAND) mul i - cen e ial and heo y-based p ocess e alua ion in ol ed an in e en ion o suppo on-going medica ion adhe ence and a endance o ca diac ehabili a ion ollowing a myoca dial in a c ion (MI) (I e s e al., 2017). In e en ion de elopmen conside ed exis ing Coch ane e iew e idence o bo h hese beha io s (Ka mali e al., 2014; Nieuwlaa e al., 2014), key ials o beha io change in e en ions (Snieho a, Scholz, & Schwa ze , 2006), cos -e ec i eness da a (I o e al., 2012) and pilo ial da a (Schwalm e al., 2015). De elopmen also in ol ed conduc ing quali a i e in e iews based on he Theo e ical Domains F amewo k wi h pa ien s pos -MI o iden i y po en ial ba ie s and enable s, as well as quan i a i e analyses based on he Heal h Ac ion P ocess App oach o iden i y mo i a ional and oli ional co ela es o beha io (P esseau, Schwalm, e al., 2017). These sou ces o e idence in o med he basis o de eloping a logic model, beha io change echniques and modes o deli e y o he in e en ion (I e s e al., 2017). An in e disciplina y eam was assembled in ol ing pa ne ing wi h a design i m, pa ien s, a pa ien s akeholde o ganiza ion, p ima y and seconda y heal hca e p o ide s, and esea che s (heal h psychologis s, s a is icians, heal h se ices esea che s, heal h economis s, implemen a ion scien is s, and human ac o s enginee s) om he s a and h oughou o ensu e ha i could be implemen ed a scale wi hin heal hca e sys ems. An explici use -cen ed design p ocess was used o i e a i ely de elop ma e ials including de eloping pe sonas, p o o ype ma e ials, wo design cycles, pilo ing ma e ials using hink aloud and semi-s uc u ed in e iews (Wi eman e al., 2017). The Le ’s Mo e I (LMI) in e en ion aimed o inc ease physical ac i i y and dec ease excessi e seden a y beha io among adolescen s – especially hose wi h insu icien PA le els (Hankonen e al., 2016), physical ac i i y can p e en o delay onse o se e al li es yle- ela ed ch onic diseses such as ype 2 diabe es o hea disease. The aim o he in e en ion de elopmen was o c ea e a easible, accep able, e ec i e and cos - e ec i e school-based in e en ion ha could la e be scaled up. In e en ion de elopmen conside ed exis ing e iew e idence o hese beha io s and school-based heal h p omo ion in e en ions, bu also ca ied ou a sys ema ic e iew o he a ge g oup, beha io s, and con ex (Hynynen e al., 2016). De elopmen also in ol ed conduc ing quali a i e analysis o in e iews o be e unde s and he ole o PA in daily li e o Finnish oca ional s uden s, as well as analysis o pe sonal s o ies on key inci den s ela ed o PA change o e childhood and adolescence. Fu he , quan i a i e analyses in o med by he The ec ical Domain F amewo k (F ancis e al., 2012) aimed o iden i y he key co ela es o hese beha io s (Hankonen, Heino, Kujala, e al., 2017). As some pa s o he in e en ion we e o be deli e ed by eache s, a mixed-me hods s udy o examine accep- abili y o po en ial in e en ion s a egies was conduc ed among eache s (Laine e al., 2017). We conduc ed e.g., scena io wo k wi h a g oup o expe s and s akeholde s, and wi h a s uden panel, did p ac ical small ials o e.g., discussion exe cises wi h s uden s in o de o ge apid eedback o al e na i e p ac ical s a egies wi hin he s uden p og am. This esul ed in he i s e sion o he in e en ion, he accep abili y). and easibili y was in es iga ed in a andomised easibili y ial (Hankonen, Heino, Kujala, e al., 2017). An enhanced e sion o he in e en ion was hen de eloped based on his eedback (Hankonen, Heino, Kujala, e al., 2017). An ad e - isemen agency designed he ma e ials and he isual look o he in e en ion, in close collabo a ion wi h he esea ch eam, including es ing wi h end-use s and a close linkage wi h heo y. An in e disciplina y eam in ol ing esea che s (disciplines including social and heal h psychology, s a is ics, exe cise physiology and measu e men , spo s science, implemen a ion science, sociology), heal h p omo ion o ganisa ions, eache s, s uden s, school heal h specialis s, e c. was assembled om he s a and hey con ened egula ly h oughou he in e en ion de elopmen p ocess. Figu e 1. In e en ion de elopmen examples. Ó2018 Hog e e Publishing. Dis ibu ed as a Hog e e OpenMind a icle Eu opean Psychologis (2019), 24(1), 7–25 unde he license [CC BY 4.0 (h p://c ea i ecommons.o g/licenses/by/4.0/)] V. A aújo-Soa es e al., Me hods o In e en ion De elopmen 13 ${p o ocol}://econ en .hog e e.com/doi/pd /10.1027/1016-9040/a000330 - F iday, Feb ua y 15, 2019 12:57:09 AM - IP Add ess:153.1.49.17 ha deli e he in e en ion a e also he a ge o a “sec- onda y”in e en ion, hence, hei iews and beha io s should also be unde s ood. In implemen a ion science he en i onmen al agen s a e he a ge o he in e en ion. (iii) De eloping a Logic Model o Change The MRC amewo k o he de elopmen and e alua ion o complex in e en ions highligh s ha in e en ions should be heo y-based (C aig e al., 2008). A common misconcep ion is equa ing “ heo y”wi h “hypo hesis.”A scien i ic heo y has been empi ically demons a ed o explain beha io . I , while designing an in e en ion, he eam concludes ha he e is a need o a ge a combina ion o cons uc s om di e en heo ies ha ha e ne e been es ed oge he , wha will ac ually happen is ha a speci ic scien i ic hypo hesis ( ha can lead o a new heo y i suc- cess ul) is being es ed, no a heo y. I is use ul o c ea e a p og am’sscien i ichypo hesisin e ms o he e idence-based mechanisms associa ed wi h beha io and beha io change. In con as o o mal scien- i ic heo ies, p og am heo ies a e p ac ical, conc e e wo k- ing models and hypo heses o in e en ions, and a e speci ic o each p og am o in e en ion. They (1)speci y he in e en ion componen s, he in e en ion’sexpec ed ou comes, and he me hods o assessing hose ou comes, o en in he o m o a logic model, and (2) o e an in e en- ion’s“hypo heses”( he a ionale and assump ions abou mechanisms ha link p ocesses and inpu s o (bo h in ended and unin ended) ou comes, as well as condi- ions/con ex necessa y o e ec i eness; Da ido , Dixon-Woods, Le i on, & Michie, 2015). This hypo hesis o change may be based on o in o med by scien i ic heo ies, bu he main equi emen is o o - malize he hypo hesized causal assump ions, de ail he planned implemen a ion and heo ized mechanisms o impac wi hin a se o ele an con ex s (C aig e al., 2008). Theo y can also iden i y speci ic issues ha c ea e ba ie s o in e en ion success (e.g., compe ing goals in ime-limi ed GP sessions; P esseau, Snieho a, F ancis, & Campbell, 2009). Ra he han using a single heo y o guide in e en ion de elopmen , i is o en sensible o use heo y o add ess he unce ain ies in he p ocess and o c ea e a map o assump ions/hypo hesis linking heo ies and e idence. Acco ding o UK MRC Guidance, modeling an in e en- ion be o e e alua ion p o ides he insigh s ha a e key o in o ming he design o bo h he in e en ion and i s e al- ua ion. Modeling may ake he o m o a p e ial economic e alua ion es ing i he se o assump ions used o de elop he in e en ions a e su icien o p o ide a good chance o success ul impac . Mapping links be ween ou comes, de e - minan s, change objec i es, and in e en ion echniques e lec his p ocess o c ea ing he logic o in e en ion (Ba holomew Eld edge e al., 2016). Fo example, in a school-based in e en ion o p e en obesi y, pe o mance objec i es (e.g., Communica e heal hy beha io messages o pa en s and seek hei suppo ) a e mapped agains pe - sonal (e.g., sel -e icacy) and ex e nal, en i onmen al p e- dic o s (e.g., amily suppo ), and hus c ea ed ac ionable change objec i es (e.g., con idence o seek pa en al suppo and social ein o cemen om pa en s/ amily o in e es in heal hy li es yles. These change objec i es become he a - ge o in e en ion echniques (Lloyd, Logan, G ea es, & Wya , 2011). This p ocess should also in ol e he explici elabo a ion o a “da k”logic model, ha is, a ca e ul elabo a ion o po en ial pa hways h ough which he in e en ion may lead o nega i e o ha m ul consequences (Bonell, Jamal, Melendez-To es, & Cummins, 2014). This ex ends beyond iden i ying po en ial ha ms by clea ly ou lin- ing he mechanisms h ough which such ha ms may ake place. The Beha io Change Wheel (Michie, an S alen, e al., 2011) is a pa icula ly use ul ecen ool o in eg a e heo y and e idence and o b ing oge he s akeholde s in making in e en ion design decisions. I is a me a-model o he in e en ion de elopmen p ocess based on a comp ehen- si e e iew and syn hesis o exis ing me hodological and heo e ical app oaches om a ious disciplines. The Beha - io Change Wheel links policy ca ego ies (guidelines, en i- onmen al/social planning, communica ion/ma ke ing, iscal measu es, egula ion, se ice p o ision and legisla- ion) wi h in e en ion unc ions ( es ic ions, educa ion, pe suasion, incen i iza ion, coe cion, aining, enablemen , modeling, and en i onmen al es uc u ing) and commonly heo ized sou ces o beha io ; Capabili y (physical and psy- chological), Oppo uni y (social and physical) and Mo i a- ion (au oma ic and e lec i e), known as he COM-B model (Michie, an S alen, e al., 2011). C. De elopmen o Ma e ial and In e ace Design decisions abou he look and eel o an in e en ion can p omo e hei sus ained use and a e hus highly depen- den on he mode o deli e , a ge audience and beha io . In a digi al in e en ion, he g aphics used, decisions abou gami ica ion and de ices used o deploy he in e en ion in luence he o e all success o a beha io change in e en- ion. This calls o mul idisciplina y wo k o inco po a e he- o ies and me hods om o he disciplines. Heal h beha io change heo ies a e no su icien o in o ming all deci- sions abou he design o an in e en ion, and o he disci- plines ha e a key ole in op imizing design decisions. The use o communi y-based pa icipa o y esea ch (Teu el- Shone, Siyuja, Wa ahomigie, & I win, 2006)suchas Eu opean Psychologis (2019), 24(1), 7–25 Ó2018 Hog e e Publishing. Dis ibu ed as a Hog e e OpenMind a icle unde he license [CC BY 4.0 (h p://c ea i ecommons.o g/licenses/by/4.0/)] 14 V. A aújo-Soa es e al., Me hods o In e en ion De elopmen ${p o ocol}://econ en .hog e e.com/doi/pd /10.1027/1016-9040/a000330 - F iday, Feb ua y 15, 2019 12:57:09 AM - IP Add ess:153.1.49.17 consensus con e ences (Be y, Chan, Bell, & Walke , 2012) o co-design wo kshops (O’B ien e al., 2016) and use -cen- e eddesign(Ca azzo,Casselman,Hamming,Ka zman,& Palme , 2012) help o make he in e en ion a ac i e, clea and ele an o he use . P oducing inal p og am ma e ials such as pos e s and ideos may in ol e c ea i e consul an s, a is s o g aphic designe s. IM sugges s w i ing design documen s o guide he c ea ion and e iewing o he ma e ials: They can help in ensu ing ha beha io al science insigh s and in e en- ion s a egies a e adequa ely ans e ed in o ac ual ma e- ial p oduc ion. D. Empi ical Op imiza ion Once he in e en ion p og am is designed and ma e ials de eloped in o a ‘be a’ e sion, he e is he need o e ine- men and op imiza ion. Building in ime o his ex a s ep will inc ease u u e accep abili y and easibili y o he in e - en ion. The e a e igo ous me hods ha can be used o ge ex a in o ma ion o p oceed wi h empi ical op imiza ion/ e inemen o he in e en ion p io o wide scale e alua- ion, such as he Mul iphase Op imiza ion S a egy (MOST). Quali a i e and/o quan i a i e me hods can acili a e op i- miza ion/ e inemen . MOST is a amewo k o obus empi ical op imiza ion and e alua ion o beha io change in e en ions (Collins e al., 2007; Collins, Nahum-Shani, & Almi all, 2014). MOST p oposes h ee phases: p epa a ion (i.e., de elop he- o e ical model and highligh unce ain ies abou mos e ec- i e in e en ion ea u es), op imiza ion (i.e., componen selec ion using empi ical es ing), and e alua ion (i.e., de ini i e RCT). A he op imiza ion phase in e en ion de elope s ga he empi ical in o ma ion on each in e en- ion ea u e by conduc ing a andomized expe imen (e.g., ac o ial design, ac ional ac o ial design, SMART designs). The esul s om his o mal es ing in o m deci- sion-making p ocess in e ms o ea u e selec ion and o - ma ion o he op imized in e en ion. The amewo k p oposes an i e a i e p ocess s a ing ha i an op imized in e en ion is shown o be e ec i e h ough a o mal es , i can be made a ailable o he public. The key elemen in MOST is he p ocesses by which a mul icomponen beha - io change in e en ion and i s componen s a e op imized be o e a de ini i e ial o po en ially while he in e en ion is in use (e.g., op imiza ion o an exis ing app). Quali a i e me hods p o ide a complemen a y app oach o suppo he de elopmen and e inemen o an ini ially d a ed in e en ion. De elope s should aim o unde s and and inco po a e he pe spec i es o hose who will use he in e en ion by unde aking i e a i e quali a i e esea ch. This is impo an o digi al in e en ions (Baek, Cagil ay, Boling, & F ick, 2008) bu also o adi ional me hods o deli e y. An example on how his can be ansla ed in p ac- ice is by elici ing and analyzing se ice use s’ eac ions o he in e en ion and i s elemen s. I migh also be impo - an o conduc consul a ion wi h opic expe s (e.g., com- pu e scien is s) and o he s akeholde s (e.g., heal hca e p ac i ione s) o he in e en ion o accommoda e hei iews and expe ise (P esseau, Mu sae s, e al., 2017;Rod i- gues, Snieho a, Bi ch-Machin, Oli ie , e al., 2017). This can be achie ed using esea ch me hods such as ocus g oups, indi idual semi-s uc u ed in e iews coupled wi h a hink-aloud p ocess. Mixed me hods can also be used o e ine an in e en ion coupling bo h quali a i e wi h quan- i a i e o ms o collec ing in o ma ion ha can in o m e inemen . E. E alua ing he In e en ion De eloping in e en ions ha es explici hypo heses could allow o syne gy be ween knowledge gene a ed ia he implemen a ion and e alua ion o in e en ions and heo- ies, allowing o hei es and e olu ion. In he pilo and easibili y s age he easibili y and accep abili y o he in e - en ion and e alua ion p ocedu es is es ed and i needed op imized and addi ional in o ma ion needed o design he e alua ion is collec ed (Eld idge e al., 2016;Lancas e , 2015). Once a iable in e en ion and e alua ion p o ocol has been achie ed, a ull-scale e alua ion o whe he he in e en ion has i s in ended e ec s on he main ou come should ake place assuming esou ces a e a ailable o do so. The s udy design should be chosen based on wha is i o pu pose –based on ques ion, ci cums ances, and speci- ic cha ac e is ics o he s udy (e.g., expec ed e ec size and likelihood o biases). Conside ing he ange o expe imen al and non-expe imen al app oaches should lead o mo e app op ia e me hodological choices (Shadish, Cook, & Campbell, 2002). UK MRC guidance s ongly encou ages conside ing andomiza ion, due o i being he mos obus me hod o p e en ing selec ion bias (i.e., in e en ion ecip- ien s sys ema ically di e ing om hose who do no ). In case a con en ional indi idually- andomized pa allel g oup design is no app op ia e, e alua o s should conside o he expe imen al designs, o example, clus e - andomized i- als, s epped wedge designs (Li e al., 2017), p e e ence ials and andomized consen designs, o n-o -1designs (C aig e al., 2008; Shadish e al., 2002). E en when an expe i- men al app oach may no be easible, o example, he in e en ion is i e e sible, obus nonexpe imen al al e na- i es should be conside ed. In any case, in e en ion e alu- a o s should be conscious o he need o a oid unde powe ed ials o p e en p oducing esea ch was e (Ioannidis e al., 2014). Ó2018 Hog e e Publishing. Dis ibu ed as a Hog e e OpenMind a icle Eu opean Psychologis (2019), 24(1), 7–25 unde he license [CC BY 4.0 (h p://c ea i ecommons.o g/licenses/by/4.0/)] V. A aújo-Soa es e al., Me hods o In e en ion De elopmen 15 ${p o ocol}://econ en .hog e e.com/doi/pd /10.1027/1016-9040/a000330 - F iday, Feb ua y 15, 2019 12:57:09 AM - IP Add ess:153.1.49.17 synd ome. JMIR Human Fac o s, 4, e6. h ps://doi.o g/10.2196/ human ac o s.6502 Wo ld Heal h O ganiza ion. (2014a). Global Heal h Es ima es: Dea hs by cause, age, sex and coun y, 2000–2012. Re ie ed om h p://www.who.in /heal hin o/global_bu den_disease/ en/ Wo ld Heal h O ganiza ion. (2014b). Global s a us epo on noncommunicable diseases 2014. In WHO.. Gene a, Swi ze - land: WHO. Ya dley, L., Mo ison, L., B adbu y, K., & Mulle , I. (2015). The pe son-based app oach o in e en ion de elopmen : Applica- ion o Digi al heal h- ela ed beha io change in e en ions (Eds.), Jou nal o Medical In e ne Resea ch, 17, e30. h ps:// doi.o g/10.2196/jmi .4055 Recei ed May 20, 2017 Re ision ecei ed Feb ua y 21, 2018 Accep ed Ap il 19, 2018 Published online Augus 16, 2018 Ve a A aújo-Soa es Ins i u e o Heal h & Socie y Facul y o Medical Sciences Newcas le Uni e si y Baddiley-Cla ke Building Richa dson Road Newcas le upon Tyne NE2 4AX UK e a.a aujo-soa es@newcas le.ac.uk Ve a A aújo-Soa es, PhD, is a Senio Lec u e in Heal h Psychology in he Facul y o Medical Sciences, Ins i- u e o Heal h & Socie y and he School o Psychology, Newcas le Uni e si y, UK. He esea ch ocuses on he de elopmen and assessmen o e idence-based in e en ions o he p omo ion o heal h beha io s, p e en ion and sel -managemen o ch onic condi ions. She is P esiden Elec o he Eu opean Heal h Psy- chology Socie y. Nelli Hankonen, PhD, is Assis an P o esso (Social Psychology) in he Facul y o Social Sciences a he Uni e si y o Helsinki. He esea ch ocuses on changing mo i a ion and beha io in he a ea o well-being and heal h and in mechanisms o change in complex in e en ions. Jus in P esseau, PhD, is a Scien is and Heal h Psychologis a he O - awa Hospi al Resea ch Ins i u e and Assis an P o esso in he School o Epidemiology, Public Heal h and P e en i e Medicine a he Uni e si y o O awa. His esea ch d aws upon heo ies and app oaches om heal h psychology and beha io al medicine o de elop and e alua e in e en- ions ocused on changing heal h- ca e p o essional beha io s and heal h beha io s o pa ien s and he public. Angela M. Rod igues, PhD, is Re- sea ch Associa e in he Facul y o Medical Sciences, Ins i u e o Heal h & Socie y, a Newcas le Uni e si y and in Fuse, he UK Cen e o Excellence o T ansla ional Re- sea ch in Public Heal h. Falko F. Snieho a, PhD, is Di ec o o he NIHR Policy Resea ch Uni Beha iou al Science and P o esso o Beha io al Medicine and Heal h Psychology in he Facul y o Medical Sciences, Ins i u e o Heal h & Socie y, a Newcas le Uni e si y and in Fuse, he UK Cen e o Excel- lence o T ansla ional Resea ch in Public Heal h. His esea ch ocuses on he de elopmen and e alua ion o complex beha io al in e en ions o indi iduals and popula ions. He is pas p esiden o he Eu opean Heal h Psychology Socie y. Eu opean Psychologis (2019), 24(1), 7–25 Ó2018 Hog e e Publishing. Dis ibu ed as a Hog e e OpenMind a icle unde he license [CC BY 4.0 (h p://c ea i ecommons.o g/licenses/by/4.0/)] 22 V. A aújo-Soa es e al., Me hods o In e en ion De elopmen ${p o ocol}://econ en .hog e e.com/doi/pd /10.1027/1016-9040/a000330 - F iday, Feb ua y 15, 2019 12:57:09 AM - IP Add ess:153.1.49.17 Appendix A In e en ion De elopmen and E alua ion F amewo ks and Pu pose F amewo ks Pu pose MRC F amewo k o he De elopmen o Complex In e en ions (C aig e al., 2008) To p o ide guidance on he p ocess o de elopmen , e alua ion and implemen a ion o a a ge in e en ion. In e en ion Mapping (Ba holomew Eld edge e al., 2016) To desc ibe he i e a i e pa h (six phases) o designing, implemen ing and e alua ing an in e en ion. S eps o de eloping a heo y-in o med implemen a ion in e en ion (S. D. F ench e al., 2012) To suppo he de elopmen o an in e en ion designed o change clinical beha iou based on a heo e ical amewo k. PRECEDE-PROCEEDE (G een & K eu e , 2005) The model aims o explain heal h- ela ed beha iou s and en i onmen s, and o design and e alua e he in e en ion. The Beha iou Change Wheel (Michie, A kins, & Wes , 2014) This ool de ails how o design and selec in e en ions acco ding o a beha iou analysis, mechanisms o ac ion, and he in e en ions equi ed o change hose mechanisms. This ool is also used o link in luences on beha iou o po en ial in e en ion unc ions and policy ca ego ies. The Pe son-Based App oach o In e en ion De elopmen (Ya dley, Mo ison, B adbu y & Mulle , 2015) To design in e en ions based on igo ous, in-dep h unde s anding o he psychosocial con ex o use s, and de i ed om i e a i e in-dep h quali a i e esea ch. 6SQuID: 6 s eps in quali y in e en ion de elopmen (Wigh , Wimbush, Jepson, & Doi, 2016) To p o ide a p agma ic and sys ema ic six-s ep guide o in e en ion de elopmen , maximising i s likely e ec i eness. E idence-guided co-design (O’B ien e al., 2016) To desc ibe a sys ema ic, sequen ial app oach o in eg a e scien i ic e idence, expe knowledge, and s akeholde in ol emen in he co-design and de elopmen o an in e en ion. Knowledge- o-Ac ion (KTA) cycle (G aham e al., 2006) A concep ual amewo k o in eg a e he oles o knowledge c ea ion and knowledge applica ion, con ibu ing o sus ainable, e idence-based in e en ions. ORBIT model (Czajkowski e al., 2015) To p o ide guidance on he p ocess o ea men de elopmen by sugges ing he use o a p og essi e, ansdisciplina y amewo k o acili a e he ansla ion o basic beha iou al science indings o clinical applica ion. EM Model (Shee an, Klein, & Ro hman, 2017) To de ail he p ocess in ol ed in designing in e en ions o gain mo e cumula i e science o heal h beha iou change. Mul iphase op imiza ion s a egy (MOST; Collins, Mu phy, & S eche , 2007) To p o ide a guide o he op imiza ion and e alua ion o mul icomponen beha iou al in e en ions. Social Ma ke ing (e.g., Le eb e, 2011) The sys ema ic applica ion o ma ke ing concep s and echniques o achie e beha iou change. Ó2018 Hog e e Publishing. Dis ibu ed as a Hog e e OpenMind a icle Eu opean Psychologis (2019), 24(1), 7–25 unde he license [CC BY 4.0 (h p://c ea i ecommons.o g/licenses/by/4.0/)] V. A aújo-Soa es e al., Me hods o In e en ion De elopmen 23 ${p o ocol}://econ en .hog e e.com/doi/pd /10.1027/1016-9040/a000330 - F iday, Feb ua y 15, 2019 12:57:09 AM - IP Add ess:153.1.49.17 Appendix B Key Conside a ions o he Repo ing o In e en ion De elopmen P epa a o y wo k: Desc ibe he eam and planned de elop- men p ocess a. Desc ibe he expe ise o he co e eam and ad iso y s ake- holde eam in ol ed in de elopmen /design p ocess (in di e en phases): mul i-disciplina i y, p io expe ience b. Desc ibe ime used (and a ailable) o in e en ion de el- opmen p ocess (e.g. leng h o design pe iod, equency o design mee ings, e c.) c. Desc ibe o he esou ces a ailable d. Desc ibe possible unde /commissione demands/limi a- ions/ eques s o he in e en ion o he de elopmen p ocess (e.g. u u e use, use o echnology, limi ed inan- cial esou ces, quick imeline o de elopmen ) e. Desc ibe o iginal gene al aims and in ended use/scalabil- i y o he u u e in e en ion S ep 1: Analyse he p oblem and de elop an in e en ion objec i e a. Desc ibe how he planning g oup wo ked o de ine he heal h p oblem, heal h beha io s, a ge heal h beha io s b. Desc ibe po en ial ma ke analysis, segmen a ion, and possible subsequen esul ing decisions c. Desc ibe he decision p ocess leading o p io i isa ion and selec ion o a ge g oup(s) and beha io change a ge s d. Desc ibe how p epa a o y beha io s and ne wo ks o o he beha io s we e iden i ied and p io i ised S ep 2: De ine he scien i ic co e o he in e en ion (i) Unde s and causal/con ex ual ac o s (Causal Modelling) a. Desc ibe o mal (beha io al) heo ies used in unde s anding he p edic o s o he a ge heal h beha io b. Desc ibe how key unce ain ies we e iden i ied o selec aim o e idence syn hesis c. Desc ibe li e a u e sea ch and e iew p ocess d. Desc ibe he a ionale/aims and he p ocess o (possible) o iginal empi ical esea ch e. Desc ibe a ing o in luencing ac o s (psychologi- cal, social, p edic o s/mechanisms) o changeabil- i y and ele ance (ii) De elop a logic/ heo e ical model a. Desc ibe he p ocess o de eloping he logic model (i possible, include ea ly and la e e sions o he logic model) b. Desc ibe key explici c i e ia (e.g. accep abili y, cos -e ec i eness) in making decisions o logic model c. Desc ibe whe he and which o he simila exis ing in e en ions we e used in de eloping he logic model, o whe he an exis ing in e en ion was used as co e basis and e o i ed o accoun o new con ex d. Desc ibe key unce ain ies le in he causal chain o logic model and he possible “weak links” he de elopmen eam hinks he e may emain e. Assess e aluabili y po en ial o such an in e en- ion . De elop a da k logic model ha desc ibes conside - a ions made a ound po en ial unin ended conse- quences and s eps made o a oid i (iii) De ine in e en ion ea u es a. Desc ibe decision p ocesses (including conside ed al e na i e op ions) leading o decisions abou i. p og am componen s/ac i i ies ii. in e media e a ge s iii. beha io change echniques o me hods o a - ge p edic o s/mechanisms e.g. o wha ex en a ious combina ions o BCTs we e explici ly conside ed and le ou i . dose/in ensi y/ equency/du a ion o in e en- ion . deli e y channel(s) i. p o ide s (expe ise/backg ound/ aining) ii. loca ion/in as uc u e b. Desc ibe whe he and how an icipa ed accep abil- i y o in e en ion among a ge pa icipan s and/ o p o ide s and/o commissione s was in es iga ed c. Desc ibe he decision p ocesses ela ed o oom o local adap a ion and necessi y o ideli y o a ious componen s S ep 3: Design/De elop in e en ion ma e ials a. Desc ibe how p o ocol was w i en b. Desc ibe key p inciples in designing ma e ials (e.g. design documen s) c. Desc ibe how s akeholde inpu was ob ained o key decisions (e.g., scena io-based wo k) d. Desc ibe whe he and how small-scale p e- es ing o in e en ion componen s (e.g. g oup exe cises, key messages) was conduc ed, o make decisions abou p og am con en e. Desc ibe decisions leading o pe sonaliza ion and ai- lo ing (how and why) . Desc ibe he p ocess o de eloping p ocedu es o ensu e ideli y Eu opean Psychologis (2019), 24(1), 7–25 Ó2018 Hog e e Publishing. Dis ibu ed as a Hog e e OpenMind a icle unde he license [CC BY 4.0 (h p://c ea i ecommons.o g/licenses/by/4.0/)] 24 V. A aújo-Soa es e al., Me hods o In e en ion De elopmen ${p o ocol}://econ en .hog e e.com/doi/pd /10.1027/1016-9040/a000330 - F iday, Feb ua y 15, 2019 12:57:09 AM - IP Add ess:153.1.49.17 S ep 4: Conduc an empi ical op imiza ion a. Desc ibe key ( esea ch) ques ions o empi ical op imisa ion b. Desc ibe empi ical design used in es ing he in e en- ion (o i s componen s), including da a collec ion me hods, sample, e c. c. Desc ibe da a analysis me hods d. Desc ibe whe he and how quali a i e and quan i a i e me hods we e mixed e. Desc ibe how judgmen s and op imiza ion decisions we e made based on empi ical es ing S ep 5: Design and unde ake in e en ion e alua ion a. Desc ibe he plan o e alua ion o e ec i eness b. Desc ibe a ionale (e.g. esou ces a ailable, unde in e es s) leading o decisions ega ding e alua ion c. Desc ibe he plan o e alua ing p ocesses d. Desc ibe he in ended use o in o ma ion gained (e.g. o po en ial adap a ions) S ep 6: Design implemen a ion and unde ake implemen a- ion e alua ion a. Desc ibe how decisions ela ed o implemen a ion (speci ic plans on how he in e en ion will be used in ou ine p ac ice) we e done, e.g., was he imple- men a ion in o med by a heo e ical amewo k o a model b. Desc ibe he implemen a ion in e en ion de elop- men p ocess c. Desc ibe each and allowed adap a ions d. Desc ibe he plan o e alua ion o implemen a ion e. Desc ibe a ionale (e.g. esou ces a ailable, unde in e es s) leading o decisions ega ding e alua ion . Desc ibe he plan o e alua ing p ocesses o implemen a ion g. Desc ibe he in ended use o in o ma ion gained (e.g. o po en ial adap a ions) Ó2018 Hog e e Publishing. Dis ibu ed as a Hog e e OpenMind a icle Eu opean Psychologis (2019), 24(1), 7–25 unde he license [CC BY 4.0 (h p://c ea i ecommons.o g/licenses/by/4.0/)] V. A aújo-Soa es e al., Me hods o In e en ion De elopmen 25 ${p o ocol}://econ en .hog e e.com/doi/pd /10.1027/1016-9040/a000330 - F iday, Feb ua y 15, 2019 12:57:09 AM - IP Add ess:153.1.49.17