Unpacking the behavioural components and delivery features of early childhood obesity prevention interventions in the TOPCHILD Collaboration: a systematic review and intervention coding protocol

Introduction: L it tle is know n abou t how early (e .g., c ommenc ing a n tena tally or in the fi r s t 12 month s aft er bir th) o be sity pr ev entio n inte rven t i o ns se ek to cha nge b eh aviour a n d whic h c omponent s a re or are no t e f f e c tive . Thi s s tudy aim s to 1 ) c harac teri se e a r l y obe si ty prev enti on int erve ntion s in t erm s of ta rget b e haviou rs, d eli very f ea t u r e s, a n d behav iour cha nge tec hniqu e s (B CTs ), 2) ex plore similari tie s an d di f fer ence s in B CTs u s e d t o ta r g et be hav iour s , an d 3) e xplor e ef fe c tivene ss of interve n t i on compo n ent s i n pr eventing c hil dhood obe si ty.

a nd analy s is: Annual compre h e ns iv e sy stem atic sea rch e s w ill b e per fo rm ed in E pub Ahead o f Pr i n t/ M ED LIN E , E m b a s e , C o c h ra n e (C EN TR A L ) , C I NA H L , Ps y cI N F O , as w e l l as c l in i ca l t r i a l r eg i st r ie s. Eli gible r a ndomi sed co n t roll e d tr i al s of b ehav ioural i n t e r v e ntion s t o pr e ven t c hild hood o be s i ty co mmenci ng antena t a lly or in th e fi r s t y e ar af ter bi rth wil l be i nvit ed to jo in th e TOP CHILD Coll abo rati on. S ta nda rd ont ologie s w ill be use d to cod e targ et beh a viour s, del iv er y featu re s and BCTs in b ot h publi sh ed an d unpubli sh ed i nter v en tion ma t e r i a ls p r ov ided b y tri ali st s . Narr ative synth e se s will be per form ed to summari se in terve ntio n compo n ent s a n d comp are appli ed B CT s by type s of t arge t be havio u rs. Ex plorat ory a na lyse s will be und ert ak en to as se s s ef fe ctiv ene s s of interve n t i on comp on ent s. Ethic s and dis semination: T he st u dy ha s bee n app rove d by T he Univer sity o f S ydney H u man Res earch E thics Commit tee ( p r oje c t no. 20 20/273) and Flind e rs Univer si ty Soc ial and Beh aviou ral Res earch E thics Commit tee ( p r oje c t no. HREC CI A2133-1 ). Th e study ’ s f i nding s wi l l be di ssemin at ed through pe er-rev i ewed public ati on s, con fe renc e pr e sen tati on s, and ta r g e t e d com mu nica t io n with ke y st a ke hold e rs. Dis c us sion: Our s tu dy will provide an in d epth und er sta nding of b ehavi oura l co mponent s an d deli very fe a t u re s u sed in ob esi t y preven t ion interve ntion s sta r t ing ante nat al ly or in t he fi r s t 12 month s af ter bi rth . Unde r s tand in g com mon interven tion app roac h es in a sy st e matic way will provide much need ed in s i ght to adv ance t he de sign o f e arly ob e s i ty pr e ven tion i n t e r v en tion s and provide th e oppor tunity t o un der t a ke fut ure qua n t i t a t iv e pr edic tive m odelling . . CC-BY-NC 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint The copyright holder for thisthis version posted December 19, 2020. ; https://doi.org/10.1101/2020.12.17.20248435doi: medRxiv preprint 2 Registra t i on PRO S PER O regi stratio n no. CRD42020 177408

Early chi ldhood obe s i ty, behav iour cha nge tec hniqu e s, int erve n t i on comp one nt s , i nfan ts STRENGTHS AND LIMITATIONS OF THIS STUDY • This study provi de s an un de rs tanding o f behav iour s t arge te d, b ehav iour cha nge t ec hnique s and deliv er y f eatu re s u s e d in ea r l y ch ildh ood ob e s ity pre venti on t ri al s i d enti fie d in a sys t e ma tic rev iew a s b eing e ligibl e fo r in clu s ion in t he Tran sforming O b e sity Pr ev ention in CHILD ren (T OP CHIL D) Coll abo rati on. • Ex t e nds prev iou s meth od s by c oding behav iour cha nge tec h nique s in p ubli sh ed a nd unpubl ishe d int erven tion mat erial s a nd pe r f orming cro s s v alida t i o n with tri ali st s t h r oug h th e TOPCH ILD Coll abo rati on. • Us in g st a ndardi se d codi ng tax onomie s w il l allo w for co mpari son s ac ro ss st ud i e s , and w e wil l pilo t t es t new ont ologie s f rom th e Huma n Behav iour Change Project . • Ex plores t he comp lex a r e a of targe ting p aren t and c aregi ve rs’ behav iou rs to im pa ct c hild outco me s a cro s s four k ey obe s i ty pr e ven tion be h aviou r a l domai n s (rel a t in g to in f ant f ee ding prac t i ce s, food p rovi s i on and pa rent fe e d ing prac tice s, mov emen t prac ti ce s, slee p he alth prac t i ce s ). • Thi s s tudy w ill prov ide preli min ary re sul t s reg a rding th e exami nation of i n t e r v en ti on co mponent s ’ ef fec tiv ene s s ba s e d on exp lorato r y anal ysi s. Y et , the in ter natio na lly un ique datab a se t h i s pr oje ct crea t e s w ill fu rth er our under sta nding o f e ffe ctive int erven ti on co mponent s in futu re re se arch . • To d ate we alr eady have 38 out o f 65 elig ible trial s a gre eing to s h are d ata , sinc e n ot all tri al s may provide unpubli shed m a ter i al w e may perfo r m sen sitivi t y anal y se s c ompa rin g t ria l s tha t hav e sha red da ta to t ri al s tha t h ave n ot shared ma teri als .

Chil dhood ove r w eight a n d obe sity a re a globa l co ncern, w ith 2019 e stima te s i n di cating tha t 38 mill ion ch ildren unde r th e age o f five y ea rs a re a ff ec t e d . 1 Incr ea sing r a te s of ov e r weig ht and obe s i ty hav e bee n ob se r v ed in young children in low - and mid dle -inco me cou n t ri es , hig hli ghting thi s wi des p rea d i s s ue a nd the ov erlap o f u nd ernutritio n and obe si ty a s a d ouble bu rd en for p ublic hea l t h sys t e m s . 2 3 T he c au s e s o f c hildho od ob e si ty are m ulti face ted , incl uding g enetic , ep ige netic, . CC-BY-NC 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint The copyright holder for thisthis version posted December 19, 2020. ; https://doi.org/10.1101/2020.12.17.20248435doi: medRxiv preprint 3 env ironmen tal, soc ial a nd b ehav iour al fa c tors. 4 M a n y s u gg es t t hat o bes i t y p r e v ent io n s h ou l d s t ar t early in li fe , if no t pre na ta lly or prior to c onceptio n , to e s t a bli sh h ealthy beh av iou ral pa tter ns in you ng ch ildren and avoid met abolic prog rammin g that wi ll c ont i nu e ac ro ss th e lif e cour se. 5 6 Par ent s and c a regiv er s p lay a key role in s hap ing c hildr en’ s dev el opmen tal enviro nme nt and beha viour s, pa rticul a r l y in the first ye a r a ft er bir t h when c hildren a r e d epend e nt o n their pa ren t s’ a n d c a r e gi v e rs ’ g u i d an ce . 7 8 W hi le in fan t b ehavi our a l o utcom e s a r e th e focu s for e arly obe sity preve nt i on, par ent s a nd c aregiv er s a r e the key age nts o f c hange . 8 P aren t s a nd ca r e give rs sh ould be suppo rte d to ob tain t he knowl edge a n d ac quired be h aviour t o a ct in w ays t hat p r ovide infan t s with home environme n ts to d ev elop op tima l ene r g y-b alan ce r ela t e d be hav iour s , re sul ting in fav oura ble infan t fe e ding, die tary in tak e, phy s ic al a c tivi t y , se den tary be h aviour, a nd sle ep. Trial s c ommenc ing a n t e na tally or in t he f irs t 12 month s a fte r birt h are from he re on r e fe r r ed t o a s early obe si ty prev enti on int erven t i o n s . Man y of th e fi rs t o f s uc h c ompl ex t ria l s b egan i n 2006-20 09 (e.g . 9-15 ). Thes e tri al s aimed to modi fy s e ve r a l pare nt be h aviour s know n to be a ss ocia ted with in fan t obe sity ri sk. S ince the fir s t t rial s, the nu mb er of early obe si t y preven tion int erve ntion s ha s grow n sub s t anti a lly, pr ov iding an ex ten s i ve ev idenc e ba se to inf orm ho w we s e ek to pr ev ent th e glob al is s ue o f chi ldhoo d obe s ity . This evi d ence base con tin u es to g r o w a s more e a r l y ob esi ty prev en tion interve n t i on s a re deve lo ped an d te s t ed. 16 Interve n t i on s pu bli sh ed to da te, vary i n t h eir e f fectiv en e s s to reduc e chi ldhood ob e s ity and en e r g y- bala nce r ela te d beha viou r s . 7 16-18 A p ot e n t i al s ource o f va r i ation in i n t e r v en tion e f fec tive ne s s may be the c ompon ent s o f the in te rven t i o ns . Inte rventio n compon en ts c an dif fe r, s uch as be hav iour s ta rge te d, del iv ery fe atur es (e.g . mode, se tt i ng ) and b eh avi our chang e t ech nique s (B CT s). Littl e i s k nown a bou t whic h co mponent s ar e inc luded i n early ob e sity preve n t i on in ter vention s seeki ng to c h ange behavi ou r , a nd w hich of t h o s e inc luded s pec ific compon e nts a re a nd a r e not e ffe ctive . 19 Inte rve nt i on s d e s ig ned to modi fy th e trajec tory of a y oung c hild’ s growth traje c tor y are hy po the s i zed t o exe rt th eir e f fe c t by c hanging paren tal beh av iour s tha t i nfl uence chi ld re n’ s e ne rgy ba lanc e. Tra ditio n ally, the di f fer ent co mponent s o f beh av iour cha nge in te r v e ntion s ar e under - sp ecifie d in publ i s he d r eports c on t ribu tin g to a p oor un der standi ng o f the w ay s in whic h ef fectiv e in terve n t i on s ha ve thei r i mpact (i. e. the ‘bla ck box’ proble m) . 19 T his limit s th e abi l it y of re s earch er s and p rac titi oner s t o o pt i mise , imple men t and s c al e up e ff ectiv e int erven tion s th at are ne eded to p r ev e nt chi ldhoo d obe s ity . 19 20 Exploring the ex t e nt t o whic h the t arge t be haviou rs , d eli very fe a t ur e s and B CTs di f fer b etwee n interven tion s may help to und er s t an d why s ome in terven ti ons wo r k be tt er t h a n oth er s . . CC-BY-NC 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint The copyright holder for thisthis version posted December 19, 2020. ; https://doi.org/10.1101/2020.12.17.20248435doi: medRxiv preprint 4 Deco n structing in terven tion s int o thei r c omponent s ca n p rovide impor t a nt in fo r mation abo u t t h e paren tal beh av iour s tha t w ere targe ted f or c hange , how a n int erven tion wa s del iv ered (i.e . deliv ery fea tur es ), an d the b ehavi our chan g e tec hnique s (B CT s; i. e. t h e s m a lle st, mea sura ble a nd reprod uci ble beh a viour c hange compon e nts) 21 use d to cha ng e pa r e nts’ be h aviour . Dec on structi ng interve n t i on s i n thi s way is p o s si ble t h ro ug h the u se o f ontol og ie s t o s y s tem atic al ly categ ori s e va r i ous i n t e r v ention c ompo nen ts . 21-23 While the re ar e seve ral repo rt i ng ch eckl i s t s , taxon omie s and ontolog ie s avai l able to de s c rib e beh avio ur c hange inte rventi on s, th e BCT Tax ono my v 1 (BCTTv 1) to speci fy BCT s i s one o f th e most c ommonl y us e d, inc luding exami na tion o f obe s i ty- rela te d interve n t i on s a mong a dul t s . 24-26 Res earch e rs hav e ex plor ed B CTs in pa ren t-foc u sed in terve ntion s targe ting chi ld o besi ty- rela ted beha viour s, inc luding in fan t fe eding prac tic e s , die tary be h avio urs and phy sica l ac tiv ity pa t te rn s. 27-31 The pr o po s ed work bu ild s on p rior work b y Martin and coll e ague s 30 and Ma t v i enko-S ikar a nd co lleag ue s 29 that id e nti fie d c omponen t s of int erven tion s ta rgeting ob e sity, f oc use d on physic al ac tivity a nd ea ting , and in fant fe edin g int erventi on s (in 2 to 18 y ear o ld c hildren a nd infan t s, re spectiv ely ). T he cur rent p rojec t adva nc es p revio u s rev iew s by exam ining i nt e r v e ntion s co mmenci ng antena t a lly or within on e yea r o f birt h , cove r i ng all obe si ty-r eleva n t behav iour s (rel ating to in fan t f eedi ng, di e t a r y intake , physic al ac tivity, s ed e nta r y beha viour , sl eep) , draw ing on unpubl ishe d mat erial d e s c ribing i nte r v en tion s and u sing t he mo st c ompreh en sive BCT tax onomy (i. e . BCTT v1). 29 30 32 To da te, no rev iew h a s co mprehen sive ly e xplor ed the in te r v ention c omponent s o f early obe si ty prev enti on int erven t i o n s a c ross mul tipl e be hav iour s or u t i li s e d unpu blish ed interve n t i on ma teri als . Member s o f our r e sea rch te a m have pre viously applie d a c omp rehe nsive a ppro ach t o bet t e r under st and f ac t o rs co n t ribu ting to t he e f fec t i ven e s s of four early ob e s i ty preven ti on i nter v e ntion s undert ak en in Au s tr a lia a nd New Z eala n d. 33 T he approac h inc lude d analy s ing the co nt e n t of interve n t i on s u sing de scrip tion s o f inte rvention s in bo t h publi she d pe e r r e view ed articl e s a n d unpubl ishe d mat erial s (e.g . par ticipa nt m anual s , t el epho ne script s , vide o s ) . T he n umber of B C T s iden t i fi ed from publi sh ed m at er i al s only (1 to 11 BCT s pe r tri al) 29 wa s m uch small e r t ha n whe n inc luding unpublish ed mat erial s (13 to 2 5 B CTs p er tr i a l) , 33 rei nfo r c ing the impo rta nce of an aly s i ng unpubl ishe d int erven tion mat erial s to ob tain a more ac curat e und e rstandi ng of su ch interv en tion s . 34 This prio r w or k was li mite d to four tr i al s i n one geographi c al r e gion a nd re s ul ts m ay not be gen erali sa ble o n a gl obal l e vel. Fur t h e r mo r e , s ma ll sample s iz es hi nder ed e xplora tion of BCT s by the . CC-BY-NC 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint The copyright holder for thisthis version posted December 19, 2020. ; https://doi.org/10.1101/2020.12.17.20248435doi: medRxiv preprint 5 type s of b e haviou rs t arge ted. We pr o po s e e xtending thi s inn ovativ e app roa ch to i nc lude all ong oing and comple te d tr i a ls in thi s fi eld a nd ana l ysing BCT s to a d dr e ss all re levan t ta r g e t behavi ours in bo th publi s h ed and unpu bl ish ed int erven tion materi als . The curren t study wil l answe r the fol lowi ng ques tion s : 1) What a r e t h e ta rget ed beh aviou r s, deli ve ry fea t ure s an d behav iour cha n ge tec hn i que s us ed in ea r l y obe si ty prev enti on int erve nti on s ? 2) What a r e t h e s i mil ariti e s and d i ffe r e nc e s in be havio ur chang e techn iqu e s use d to targe t di f f e rent b e havio urs? 3) Are pa r tic ula r inte rven t io n compon en t s more e ffe ctive a t reduci ng obe si ty ri sk a mong c hildren a ged around 24 mon th s (i. e. b ody ma s s i ndex z - score ) th an ot h ers? To addre s s th es e que stion s, we will code interven tion c ont ent and eval ua te th e e f fec tiven e s s of c omponent s t o preven t ob e s i ty .

AND ANALYSIS This study ha s be en pro s p e ctive ly regi s t e red on PR O S P ERO In te r na ti onal pro sp ec tiv e regis ter o f sys t e ma tic rev iew s ( CR D420201 77408). T he cu r ren t projec t will compl emen t our indi vidual partic ipan t da ta m eta - analy s is as se ssing the e ff ectiv en e ss of e arly c hild obe s ity pre vention interve n t i on s ( Hunt er e t al . unpubli sh ed ) . A sy st ematic s e a r c h ha s be e n us ed to id enti fy tr ia l s eligi bl e to join t h e Tra ns fo r mi ng Obe sit y in CH IL D ren (T OPCH IL D ) Co llab ora tion ( ww w.topc hildco llab ora tion. org ), and al l elig ible tri al s wi ll be able t o c ontrib ute to both the c u r ren t revie w an d the in div idual par t i cipa nt d at a meta -an aly si s. Thi s pro tocol fol low s th e Pre f err ed Repor ting Ite ms for S y s t ema tic r evi ew a nd Meta -An aly s i s pr otocol s (PR IS MA) c hec klist (Supp lem enta ry F ile 1 ) . 35 Elig ibility c r i t eria Trial s w ill be incl ud ed if t hey 1) ar e a ran domise d c ontrol led t rial f or w hich ran do mis a ti on ca n occ ur at th e i ndividu al le vel or by clu ste r, inc lu ding s t eppe d -wedge d e signs ; 2) inv olve p aren ts/car eg iver s (inc luding pr e gnan t w omen) and t h e ir inf ant( s) a ged 0 t o 12 mon th s at ba s elin e ; 3) are e valua ting an interve n t i on whic h c ontinu e s beyond pre gnanc y, i s c hild ob e s i ty preven tion foc u sed a nd includ e s a t lea s t on e behav iou ral c omponen t rel at e d t o pare nt feedi ng practic e s, early fe edi ng, diet qual i t y , ac tivity/ s e d ent ary beh aviour or sleep ; 4) incl ude a usua l ca r e con trol arm, no int er vention o r att entio nal cont rol; 5) includ e at l ea s t on e mea sur e o f chi ld adip o s i ty mea sure d at the en d o f interve n t i on (e.g . BMI z- scor e, prev al enc e of ov erwe igh t / obe si ty, skin fol d thick n e ss) . Trial s w ill be . CC-BY-NC 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint The copyright holder for thisthis version posted December 19, 2020. ; https://doi.org/10.1101/2020.12.17.20248435doi: medRxiv preprint 6 ex clude d if th ey f o cu s s ol ely o n ob es ity in p r eg nanc y, or inc lude n on-b ehavi oura l interven t io n s ( e. g. suppl emen ts ). S ee our comp a nion pa p er for f u rther d etai l s (Hunt er e t al . unp ubli s hed) . Infor mation sour c es and search strateg y Sy s tem a t i c sea rche s w ill be conduc t ed a nnu ally t o iden tify e ligibl e tr i al s for t he d uration of t he TOPCH ILD Coll abo rati on (c urren tly funde d until the end o f 2023). An i ni tial sys tem atic sea r c h wa s perf ormed on the 18 th o f Ma rc h 2020 in t he follo wing da taba s e s : Medli ne (Ovid ) , Embase (Ovid) , Coc hr a n e C entr al Re gi ste r o f Con tr ol l ed Trial s (CENTR AL ), CIN A HL (EBS CO ), P sycI NFO. No lim its w ere pla ced on public a tion da te or la ngua ge. A se arc h s tr at egy for Me dline i s p r e s ent e d i n Supple ment ary Fi le 2. W e a l s o s e ar ch e d C l i n ic a l Tr ia ls .g o v ( 2 4 th M a r c h 2 02 0 ) a n d o t h e r t r i a l r eg is t r ies v ia t h e W o rl d H e a lt h Or g aniza tion’ s I nte rna tional Clinic al Tria l s Re gi stry Pla tfo rm (13 th M ay 2020) s earc h port a l to iden tify pla nned and o ngoing tr i al s. Additi onal tri al s w ill be ide nti fied by c ollabo rat or s and c ontact s no tifying the re s earch t e am o f any plan ned , ong oi ng or c ompleted trial s o f w hich t he y ar e a ware a nd wi ll be scre ened for e ligibi lity. Sel ection proce s s Tw o review ers will inde pend e nt l y scre en title /ab s tr a ct s an d full te xt ar ticle s a gain st the eli gibili t y criteri a, in Cov id ence s y stema t i c revi ew s oftwa re ( Ve rita s H ealth Inno vati on, M el b ourne Au strali a) . Agreeme nt be tween rev iew ers w ill be ca lc ulated a s p ercen t ag r e ement for titl e/a bs t rac t a nd full text scree n ing. Any di sagre emen ts wi ll b e re solve d by d i s c ussi on or c on sulti ng a thi r d r ev iew er. Data ex trac t ion and ris k of bias Eli gible t ria l s w ill be invi t e d by e mail to n omi nate a rep re sen tativ e /s to join t h e TOP CHILD Coll abo rati on. Tria l repre s en ta t iv e s (i.e . t riali st s ) w ill b e con ta ct ed vi a ema il to sha re unpubl i s he d interve n t i on ma teri als for thi s curr ent r e view , in E nglish la nguage wher e p o ssible . Pr i mary ana ly se s wi ll only inc lude trial s tha t hav e provid ed both publi s hed a nd unpu bli s h e d inte rve ntion mat erial s, all owing comprehe n s iv e in terve n t io n co di ng to be p erfo rmed. If r equir ed, sen si ti vity a nalyse s wi ll be undert ak en t o com pare in terven tion co mpone nts u sing int er v ent ion de s c r ip t io n s re por ted in publi s h ed mat erial s o f tri al s tha t hav e no t sh ared in terve n t io n ma teri al s to add re s s po tenti al sel ec t i on bi as . Tw o revie wer s will indep e nde ntly ex trac t gene r a l t r i al c harac teri s t i cs (e .g. a u thor, publi cation da te , inte rve nt i o n name, me thod o f s equenc e ge ner ation and alloc a ti on c oncea lmen t, geo graphic al loc a tion, p a r tic ipa nt s) and outc ome mea s u re s, and r ec ord them in F ileMa ker (Fil eM aker P ro 1 8 Advanc ed ; Cl a r i s In ter natio nal Inc ., Sa nta Clar a, C A , U S A ). Ri sk of bia s w ill be . CC-BY-NC 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint The copyright holder for thisthis version posted December 19, 2020. ; https://doi.org/10.1101/2020.12.17.20248435doi: medRxiv preprint 7 as s e ss ed fo r th e c omplemen ta r y review exa mining interven tion e ffe ctiven e ss; ho we ver, is no t requir ed fo r th e c urr e n t s tudy fo cus ed o n de s c r i bing the con ten t of in terve nt i on s. Coding of tar g et behavio ur s, deliv ery features and behav iour chang e te chniq ues Outcome s for whic h dat a will be so ught are th e di s c re te int erven tion compon e nts th at w ill be coded by t he study te am, na mely t a r g et be hav iour s , delive r y fea ture s a nd BCT s. A s tand ardi sed pr oc edur e wi ll be fol lowed to code int erven tion ma t e r i al s with a br i e f tra ining s e s s io n held t o e nsure a ll c od er s are f a miliar w ith the proc e ss e s to a ssi s t consi stenc y i n codi ng targe t beh aviour s, d eli very fe a t ur e s and BCT s . All c od er s w ill ha ve c omplet ed a t minimum the U ni ver s i t y Colle g e L ondon onli ne t r a ining for t he Be ha viour C ha nge Te chniqu e Tax onomy v 1 (BCTTv 1; http://ww w.bc t-tax o nomy. com/ ) and , whe r e po ssible , hav e exp er i ence in co din g BCT s in pa s t pr oj ect s. All mat eria l wil l b e c oded by two inde pend ent c od er s , w hen po s sibl e, e xce ption s may i nclude when unpu bli shed ma t e r i a ls are only av ailab le in l angua ge s o the r t h an Eng li s h . Agreem ent b e t w e en c oder s will be ca lc ula t e d . Any discr epa ncie s in coding will be re s olved th r oug h discu s s i o n; or i f no c on sen s u s i s r eac hed, a t hi r d co der will be c on s ul ted to re ach con sen s us . Th e s t a nda rdi sed pr oce dure will be u sed w hen eve r pos s i bl e, how ever w he re unpubl i s h ed m ateri al s are p rovi ded in langua g es o the r t han Eng lish a modifie d p rocedu r e will be fol low ed, suc h as u s ing one c od er fl uen t in the r equir e d la nguag e re sulting in a sub s e t o f un publi shed ma te r ia l s from a tr i al bei ng co ded o nc e. I f ne c es s a ry , tr a n s l a t i on se rvice s w ill b e s o ugh t to en su r e t he int e rventio n compo n ent s c an b e approp riat e ly coded. Targe t be haviours will be c oded to c aptu re the p aren tal b ehav iour (s) add r e s sed i n e ach interve n t i on . Table 1 provide s e xample s of beh avi ours tha t ma y be ta rge te d in ea r l y obesi ty preve nt i on int erventi on s. Addi tion al beh a viours extrac te d f r om t ri a l s w ill b e iter a tivel y adde d to thi s pre -sp ecifi e d li st. Behav iou r s w ill be grou ped i nt o clu st er s o f be havio u r a l top ics, a n d the s e may inc lude i nfa nt f eedi ng practic e s , food p ro vision a nd pa ren t fe edi ng prac t ic e s, move ment pr actic e s and s l e ep he al t h p r a ctic e s ( Ta ble 1). W hi l e elig ible i nte r v en tion s can commen ce a nt e na tally , thi s st u d y is f ocus ed o n und er s t an ding the b e havio ur a l con ten t rel a ting to pa ren ta l be hav iour s direct ed towa r d s in fan ts in t he fi rst 12 to 24 mon t hs a fte r birth, r a t he r tha n focu sing o n pa rent s own he alth beha viour s. Tabl e 1: Ex amples of spec i fic p aren tal b e ha viour s grouped i n t o clu ste r s of b e havi o ur a l to pics Ta r g et par ent al beha v i ou r clust er E x a m pl e of sp ecif ic p a r e nt al b ehavi ours Infant fee di n g pra c tices P r o m ot ing an d/or s us ta inin g bre a s tfeedi ng, inclu di ng e x clu si v e b r e as tfee d i n g t o 6 m ont hs of age F ee d i n g f orm ula appr op r iat ely, if neces sary ( e.g . m a k i n g form ula p e r pack age . CC-BY-NC 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint The copyright holder for thisthis version posted December 19, 2020. ; https://doi.org/10.1101/2020.12.17.20248435doi: medRxiv preprint 8 i n s t r u c t ion s, f ee d i ng in r e s p on s e to th e in f an t ’s hung e r / sa t ie ty cu e s, f e e l in g wit h s u i ta bl e ty pes of fo r mu la ) A v o i d i ng u nn e c e s s a r y o v erf eedi n g w it h b r e a s tmi l k an d s u ppl emen tin g w it h formula D e lay ing int r od u cti o n o f s o l id f ood s ( c om p l em en ta r y f e e d ing ) un ti l 6 m on t h s o f ag e Foo d p ro vis i on an d pa r ent feed i n g p r a c tices B e h av i ou r s r e l at e d t o d ie t a ry i n ta ke P ro v id ing app ro p r i at e typ e s o f fo ods (e . g . v eg et ab l es , m e a t a nd a l t e rn a t iv e s, frui t s , w h o le grai n s , dai r y) P r ovi d i n g a ge-a ppro pria t e p o r tio ns of e ac h f ood g ro u p (i . e. p orti on s i z e s ; i ncl. l imi ti ng porti on s of mi l k) L i m i t ing p rov i si on o f c e r t a in food s a n d d r i nk s ( e .g . e ne r gy - d en se , nu t r ie nt po o r food s, s u ga r-s weete ned b everage s) Beha viours r e la ted to fe ed i ng prac tice s Offering foo ds rep e a te d l y t hat h a ve previo us l y bee n re ject e d Offering foo ds a nd drink s i n res po ns e to i n fa nts ’ hu ng e r/ satiet y c ue s (e. g . l ett in g t he infa nt deci de h ow m uc h t h ey eat, not pres s urin g t o eat) A v o i d i ng use o f f oo d t o co n trol ( or rewar d) t h e i n fa nt’s e m ot ions , beha v i o ur or cons u mpti o n of ot her fo o d s P r ovi d i n g re g u lar m e al r o uti n e s ( incl. ea ti ng t oget he r, li m it i ng di s tractio ns ) Mo v e m e n t p r a c t i c es B e h av i ou r s r e l at e d t o p hy si c a l a c t iv i ty P l a c in g in f a nt on the i r s t o m a ch fo r p r on e pl a y (‘ tu m m y t im e ’) P r o m ot ing age a p p r opria te p h y s i c al a c t i v it y s u c h as acti ve p la y , out do or p l ay, a ct i v i t ie s r e l a tin g to fund a m e n ta l m ov em e n t s k il l s P r ovi d i n g t o ys t hat pro mote mo veme nt s uc h as balls an d t oys o n w h ee l s Beha vio u rs r e la ted to s ede n t ar y be haviour Lim i ti n g t he am o unt o f t i m e t he inf an t is res t r a ined (e.g. p r am s/s tr ollers, hig h chai rs , s trap pe d o n a care g i v ers back) Lim i ti n g t he am o unt o f t i m e t he inf an t is exp ose d t o sc reens (e. g . tele v is io n, m o bi l e d evices) P ro v id ing al t e rn at iv e s to s c r e e n t im e Sl ee p healt h pract i c e s P r o m ot ing re g u la r s lee p ro uti ne ( e .g. c a l m, q uiet , so ot h ing) Letti n g th e i nf ant set tle back t o sle e p w he n s t i rr i n g/cryin g du r in g s l e ep c y c l e ( e . g . l ea v in g the r oom , on l y p i ck in g up in fa n t w h en a wak e ) P r o m ot ing a p os iti ve s le e p e n v iro n m e nt (e . g. q ui e t, d a rk ene d, w a r m ) P laci ng i nfan t i n c ot/ bass i n et w hile aw ake a n d let tin g inf ant l ea r n t o fa l l asle ep ( e . g . fo l lo win g i nf an t ’s si g n s o f ti re d ne ss ) A v o i d i ng be d -s ha ri n g / c o -s l e e p i n g (i. e. s lee pi n g w i t h t he inf ant i n t h e s a m e be d) M a x im is in g d ay-n igh t d iff ere n c e s ( e. g. li gh ts o n a n d p lay in t he da y , l i g h t s o ff a n d slee p at nig ht) Delivery featur e s re fer to a b r o a d numb er of in terv e ntion ch a r a ct eri st i c s th at re l ate t o how an interve n t i on i s deliv e red . Deliv e r y fea tur es will incl ude i tem s in the Templ a t e for I nt e r v en tion De scrip tion an d R eplic ati on (TI Die R ) r e p or ting che ckli s t, 36 suc h as w ho cond uc te d the i nte r v en tion, how (mode o f de livery) , where ( set ting) , wh en and how muc h (inten si ty), how we l l the int erve n t i on wa s d elive red ( f i d elity), a nd if ther e w ere modific atio ns mad e at the in terven tion l eve l ( Table 2). Dra ft on tologi es from the Human B ehavi our Chang e Pro ject 22 wil l be used to c ode the int er v enti on se tt i ng ( Int erven tion Se tting O ntology ), mode of d e live r y (Mod e o f Deliv e ry Onto logy) a nd so urce . CC-BY-NC 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint The copyright holder for thisthis version posted December 19, 2020. ; https://doi.org/10.1101/2020.12.17.20248435doi: medRxiv preprint 9 deli vering t h e inte rventio n (In t e rv ention Sourc e On t o logy) . S uch ontol ogie s provi d e a c ommon lan guage to d esc ribe a nd com pa re s e ve r al de livery fe atu re s acro s s in terv en tion s . D e livery f ea ture s that c ann ot be c la s s i fi ed u sing e xi st i ng c h eckl ists / on tolo gie s wil l be a d ded a s add i t i onal c a tegori e s. Tabl e 2: Deliv ery fe a t ur e s and corr e s pon d ing Human Behavi our Change Project o ntolog ie s and projec t-de velo pe d ca teg ori es b ase d on t he T IDi eR fr amewo r k Del i v e ry f e atur e s 1 E x am p le c a te go r ie s Wh y – the or y: Ra ti o n al, t he o r y or go a l Theor y n ame and / or f act ors id e nt ified a s ne e di ng to chan g e re p ort ed in in ter vent ion What – ma te r ia l s : P h y s i c a l or inf orm at io na l m a t erials , i ncl u d i n g pro v i de d t o partic i p a n t s DV D / vi deo W r i t te n m a te ri a l s News lett ers Pow erP o in t s lides We b s i t e M o b i le a pplicati o n What – p ro ce d u re s: Proce dures, acti v i ties , proces se d us e d in t he i nter v e nt ion Di da c tic ses si ons Grou p di sc u s si o n P e e r suppo r t Wh o pro vide d – int e r venti on d eli v e r ed b y : E xp e r t is e , ba ck g r oun d a nd a ny s p e c i fi c traini ng (f or e a c h in te r v e n t i o n p r o vi d er) Inte r v enti on S ou rc e On tol o g y e.g . Nursi n g prof ess io nal Co m m u n i ty h ea l t h wor ke r Die ti c ian an d N u t rit ion ist How – de li ver y m od e : (incl udes de li very t o i n d i vid uals or grou ps) Mode o f D eliv e r y O nto l o g y e.g . F a ce t o f a ce Letter M o b i le di gita l de v ic e Wh er e – i nt er v e nti on s ettin g : Loca ti o n Inte r v enti on S e t ti n g Ont o l og y e.g . Ho us ehol d r e s ide n c e Co m m u n i ty h ea l t hc a re f a c il it y Wh en and h ow mu c h – i nt er v en ti on dos e : T o t al num b e r of co nt a c ts Fre q ue n c y of c ont a c t: < weekl y , we ekl y to <mo nt hly ; m o nt hl y o r g re a te r D uratio n of c ontact: brie f, m oderat e , exte n ded T a ilo ri n g : If t h e i n t e r vent io n w as pl ann ed t o b e pe r s o n al ised, ti trated or adapt ed at t h e pa r ti c i p a n t le v el Yes – t he r e wa s an elem ent of tail oring in th e i n te rv en ti on No N o t d e sc r i be d Mo d i f i ca t ion s : If t h e i n t e r vent io n w as m o difie d d uri ng t h e stu d y at t he i n t e rv enti o n l e v el Yes – t he i nt e r vent io n w as mo difi e d No N o t d e sc r i be d Fid e l it y : Pl a n ned a n d Actu a l Fi d el i t y o f the i nte r ve n ti on ext r a c t e d as repor ted in t h e i n te rv e n t io n TIDieR: Template for Intervention Description and Replication 1 Adapted from Hoffmann et al. 36 Behav iour Change Techniques w ill be co d ed usi ng the B C TTv1. 21 Th is t a xonomy was dev e loped through a con se ns us p r oc e s s w ith exp ert s f rom a rang e o f di scip line s fr o m s ev e ral c ountr i e s , a nd . CC-BY-NC 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint The copyright holder for thisthis version posted December 19, 2020. ; https://doi.org/10.1101/2020.12.17.20248435doi: medRxiv preprint 10 sel ec t e d fo r t he cur ren t s t udy a s a mu lt i d is c iplin a r y sta ndar dise d lang uage t o cat e go r is e in t e r v enti on co nt e n t . 21 S t a nd ard co ding proc e dure s w ill be follow e d, fo r ex ample t h e whole int erventi on desc ription will be r ead b e fo r e coding . 2 B ehav iour C hang e Tec hniqu e s tha t ar e c le arly pre s e n t in the interve n t i on fr o m th e de scrip tion pr ov ided w ill be coded a s ‘Ye s’, and BCT s t h a t a re lik ely p r e sen t but w it h in suffi cien t e videnc e wi ll be coded as ‘Maybe’ . 37 38 T o be c oded a s ‘Y e s ’ the BCT s ar e requir ed to targe t par ent s (i .e . ta rget po pula tion ) and a pa ren tal b eh avi our r e l at e d to the targe t beha vioural clu s ters a s de sc ribe d in Ta bl e 1. D u e to th e co mplex number o f dif fe r ent t arget beha viour s acro s s el igib le tri al s and th e sc ope of thi s projec t, BCT s will be co ded t o the t arget beha viour c lu s t er ra the r than e ach indivi dual targ et b eh avio ur . Eac h B CT ide nti fi e d wi ll be c oded to the re le vant targe t be h aviour c lus t e r / s w hen the re i s suf fici en t de tail t o s e pa r a t e conten t in t h i s wa y. When t hi s i s not p os si ble B CTs w ill be coded t o ‘un s p eci fie d be hav ioural c lu ste r ’ . In t e r v en tion co nt e n t will be co ded f rom both pu bl i s h ed (e .g. pro toc ol s , main r e sult s , a nd foll o w -up publi cati on s) and unpubli shed i n t e r v e ntion ma teri a l s ( e. g. par tici pan t manua l s , t e le phone s c r i p t s , vi deo s). Acce ss to unpubl i s he d mate rial s i s import ant t o unde rst and de tai l s o f an int erve nt i on an d a llow coding of addi t i on al BCT s no t repo rt ed in publi she d de s c r i p t io n s. 19 34 Control arm s wi ll al so be coded f or th e pre sence o f B CTs r e leva n t t o t he t arge t popula tio n and beh avi ours, an d only B CTs unique to t he interve n t i on a rm wi ll be u s e d in the r e sul ts synth e si s. 20 T wo traine d cod er s wil l pe rform an d rec or d co ding in Micros oft E xce l. Agreem e nt o f i nitial coding be twee n cod e rs wi ll be calc ulated by ka ppa and pr e vale nc e- adj usted bi as-a djusted k appa ( PAB A K ) s ta ti stic s to as se ss streng t h of a gre emen t. 39 Fol lowing agree men t be twee n cod e rs, a v alida t i on pr oce s s will be unde rtak en . Co de d BCT s f or eac h targe t beh aviou r c lus t e r from pub li s h e d and un publi shed ma teri a l s fo r ea ch t rial will be sen t to the re spectiv e tr i ali s ts to va lida te t h e codin g. Where p os s i bl e, a virtu al me e t i ng wi ll be or g ani sed for the co der to di scu s s th e coding with the t ria l repre sen ta t iv e and t o minimize r eli ance on tr i ali s ts kno wledg e of B CTs . I f th ere a r e di s c rep a nc ies b etwe en the cod e r and trial r epr es enta tive , th e s e will be d is c u sse d to r ea ch c on s e n s u s, inc ludi ng r e fe r ring to the in terve n t i on ma teri als as th e prima r y sou r c e of e videnc e . Sy nt hesis of res ults To a ddre ss th e fir s t r e s earc h que s tion, a st ructur ed summary w ill be prep ared to desc ribe th e targe ted b e havi our a l cl u ster s , d eliv ery f e atur es and BCT s u sed i n e arly obe si t y pre vention interve n t i on s. T o addre s s t he s ec ond r e s earch que stion , na rra tive c ompari son s o f BCTs u se d by targe t beh aviou r c lus t e rs wil l be ma d e to ex plore th e simila r i t i e s a nd dif fe renc e s i n BCTs u se d to targe t dif fe ren t be haviou rs . To a ddr e s s t he third r e sea rch que s ti on , expl ora t o ry analy s e s w ill be . CC-BY-NC 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint The copyright holder for thisthis version posted December 19, 2020. ; https://doi.org/10.1101/2020.12.17.20248435doi: medRxiv preprint 11 undert ak en t o provide pr elimina r y inf or mation a bou t t h e e ff ectiv ene s s o f commonl y used interve n t i on compo n ent s i n re ducin g bo dy mass in d ex (BM I) z - s c or e s a t 2 yea rs o f ag e ( +/ - 6 month s) . For thi s pu rpo s e , a me t a - r eg r e s sion an a lysi s will be pe rf ormed for e ac h c ommonly us ed interve n t i on compo n ent (i.e . u sed i n 5 or more in t e rv entio ns), t o compare in fan t BMI z - sc o r e for trial s inc luding t h e inte rventi on c ompon ent c ompar ed t o trial s no t i ncludi ng the i nterv en tion co mponent . Our p r o po s e d appro ac h will take i nto acc ount small sampl e s i ze s and import a n tly the va r i ability of the ob s erved e f fec t s i zes , h ow ever, w ill not be a ble t o d et ermine in de pend ent e f fec t s of ea ch c ompon ent . Patients and public invol v ement The TO P C H IL D Colla bo r a ti on invol ve s a b road r a ng e of st ake hold er s includ ing hea lth pro fe ssiona l s, poli cy ma kers, r e s e a r c her s an d trial is t s . I n addition , the Colla b ora tion inc lude s a p a r e n t repr ese nt ative a nd an i nt e r v enti on fac ili t ator / nu rs e w ho have giv en input i nto an d feed b ack on thi s protocol a nd w ill be involv ed in t he in ter pr e ta t i on o f r es ults. ETHICS AND DISSEMINATION The s t udy has b een a p proved by The U ni v ers i ty of Sy dney Human Re se arch E t hi c s Committ ee (projec t n o. 2020/273 ) and Fl ind er s U niv er s ity Soci al an d B ehav iour al Re se arc h Et hics Commi t te e (projec t n o. HRE C CI A2133 -1 ). I f any ame ndme nts to thi s publi shed p r otoc ol are r equi r e d , they w ill be d ocument ed in th e PR OSPE R O reg i s t r ation r ec or d (n o. CRD420201 77408) . Fi ndings from th e cu r re nt study w ill be di ssemin a ted through p ee r-r evi ewed publi c ation s , co nfe r e nce pre sen tati on s, an d targe ted c ommunica tion wi t h key stak eho lder s, suc h as int erve n t i on design e rs. Di s s emi na ting find ing s to in te rvention d es i gn er s w ill i mpart know ledg e about co mmon interve n t i on app roac h e s used in th e fie l d of early ob e sity preve n tion a s we ll a s le s s commonl y us ed but pot enti al ly ef fec tive BC T s a nd del ive r y fea t u re s th at c an be explored in futu re interven tion s .

Our s tudy will charac t eri s e in fan t obe si ty prev entio n inte rve nt i o ns c ommenc ing a ntena tally or in th e fir s t 12 mont hs af t e r bi r th, by speci f y ing the ta r g et ed beh a viour s, deliv e ry fea tur e s and appl ied BCTs . Key stre ngth s of thi s s t udy inc lude the c ompre hen sive s y stema tic s earch t o i denti fy pl anned , ongo ing, a nd comp let ed ea rly chi ldhood obe sity pr e ven tion trial s th at w ill provi de a broa d under st anding of t h e b ehav iour ch ange c onten t and deliv e r y fea tur e s use d ar oun d the w orld. By look ing in t o t h e ‘blac k box ’ of in terv en tio ns , t hi s s tudy w ill prov ide det ai led summ arie s o f . CC-BY-NC 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint The copyright holder for thisthis version posted December 19, 2020. ; https://doi.org/10.1101/2020.12.17.20248435doi: medRxiv preprint 12 methodol ogie s us ed in e a rly c hildhood o besi t y preven tion int erven tion s glo bally . W e ar e ex tending previ ou s me t h o ds b y co ding B CTs in bo t h unpublish ed and publ i s h ed mat erial s a nd performin g cro s s va lidation o f coding with tri al i s t s th r oug h the TOP CHIL D Col l abor ation . In addi tion, we a r e explo r in g patt ern s in B CT u se a cro ss fo ur ke y obe si ty p r ev enti on pa re nt a l b eha viour c lu s t er s; nam ely infan t fee di ng prac t ic e s , fo od provi sion and pa r ent f ee ding pr ac tice s, mov eme nt pr ac t i c es , and slee p hea lth p ractic e s. W e will u s e s t anda r d i se d coding taxono mie s (i. e. B CTT v1), a nd pi lot te s t new ontolog ie s fr om the H u man B eha viour C han ge Pr ojec t 22 to sy s tematic a lly code in t e r v en tion sourc e, mode of d eliv ery and int ervent ion set tin g. T his s tudy will pr ov ide pr el iminary i n s i g ht s in to w hic h interve n t i on compo n ent s a r e mor e ef fec tiv e than o the rs . Howev er , bec au s e B CT s are not u s ed in isola tion an d inte rven t i o ns i nclud e multi ple compone n ts, it i s not p os sibl e to i sol ate the indiv idual ef fec ts o f ea ch B CT or compo n ent within a tr i al or ac ro ss tr i al s fr om the e ff ect s o f other BCT s, and ther e may be c onfou nding thr o u gh unob se rved t ri al -l evel e ff ect s. I nte rventi on c o ding will be limi t e d to indi cating th e pr e s e nce o r a b s e nce o f a BCT in inte rventi on m ate r i al s. Coding will not addr e ss whe t h er t e chniqu e s w ere in fa ct d eliv ere d to ea ch pa r tic ipan t (i .e . fideli ty of B CT) or BCT d o s e . Never thel es s , we hope th at thi s exp lora to r y anal ys i s w ill prov ide pr elim inary in sig ht i nto whic h interve n t i on compo n ent s ma y be more e ff ectiv e th an oth er s. A sy st e m atic un de rstan ding of t he c omp onent s o f ea rly obe sity pr eve nt i on in te rvention s w ill la y the groundw ork fo r cond ucting quan tit ative p r e dictive mod ell ing in f u t ure r e sea rch p roject s. The cu r ren t s tudy w ill ge nera te a c ompr ehen sive da taba s e of i n t e r v en tion c ompon ent s f or each t ria l in the TO PCH ILD C ol labor atio n i n stand a r d i s ed t e r mi n ology and c las s i fie d by ta r g et behav iour s , deli very fe a t u r e s an d B CTs . The re sul ting databa s e w ill be combine d with i ndivid u al partic ipa nt da ta obtain e d fro m TOP CH I LD tr i ali s ts ( se e Hu nter e t al, unp ubli shed pr otoc ol ) in a fu ture study to perf orm quan tita tiv e pr edic t i ve mode llin g. Predic tiv e model ling w ill fur the r our u nder st anding of ef fec t i ve in te rve ntion co mpo nen ts f o r re duc ing c hildho od obe sity, i ncludi ng id ent ific ati on of co mponent s tha t a re pa rticu la rly ef fec tiv e for k ey po pul ation g roup s. P roje ct upd ate s wi ll be public ly av ailab le on th e TOPC HIL D Coll abor ation websi te a t http s ://ww w.topchi ldcol l abor ation .org/ .

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BCT Tax onomy v1 Online Training 2020 [ Av aila bl e fr om: ht tp s :/ / w ww .bct -tax onom y.com / ac ces se d 20 Ma r 2 020. 38. Car ey RN, C onne ll L E, Jo hn st o n M , et al. Beh avi or Cha nge Tech nique s an d thei r m echa ni s ms o f ac tion: A synth e si s of link s de scrib e d in p ubl is h e d int erventi on l it er a t u r e . Ann Behav Med 2018 ;53(8) :693-707 . d oi: 10 .1093 /abm/k ay 078 39. Landi s JR, K och G G. The mea su r e men t of ob s erver ag ree men t f or cat eg or i cal d ata. Biometrics 1977 ;33(1) :159-74 . . CC-BY-NC 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint The copyright holder for thisthis version posted December 19, 2020. ; https://doi.org/10.1101/2020.12.17.20248435doi: medRxiv preprint 16 Acknowledge ment s We w ould lik e to ac know ledg e Slav ica Be rber fr om th e NH MR C Cl i nica l Trial s C ent re fo r ad vice on the sea rch stra tegy . We woul d al so lik e t o ac know ledge t he N HMR C C en t r e of Re s e a r c h Ex cell ence in Early Preven tio n o f O b e s i ty in Chil dho od, wh o s up ported t he pilo t an d founda tion al work for thi s projec t . We w ould lik e to thank Mari a L uis a Garm endia a nd C ami la Co rva lan f or th eir fee dba ck on an e arli er ve r sio n of thi s prot ocol . TOPCH ILD Coll abo rati on mem bers Stee ring Group : A n n a L e n e S e i d l e r , K y l i e H u n t e r , B r i t t a n y J o h n s o n , R e b e c c a G o l l e y , L i s a A s k i e , A n g i e Barba, Ma s on Ab er o uman d, S ol Li be s m a n Advisory G r oup : Ali son H aye s , Charl e s Wood, Chri s Ri s s el, Davi d E spin oza, De n is e O’ Conn or, Ia n Mar s c hner , Kris ty Roble do, Lou i s e Bau r, Luk as Staub , L uke W ol fen den, Mic h elle Sue -S e e, Pau l Chad wick , Rac hael Tayl o r , Sar ah T aki, Se ema Mihr s hah i , Wendy Smith , Sh onna Yi n , Lee Sand e rs Trial Repr e sen tative s ( to d at e) : Al i s on Karas z , Amand a Thomp son, An a Ma r i a L inare s, Ana Pe rez Ex pos i t o, Ata G h a deri , Bar ry Ta ylor, C a r o li na Gonz ález Acero , Ca t h le en Od ar S tou gh , Claudi o Ma ff ei s, Cri st i n a Pal a cio s, Ch ris t in e He lle, E lian a P errin, Emily O ke n, Eva Corp eleijn, Finn Ra s mu s s e n, H e a the r Wa sser, Hein Raa t, Ian P aul, Jenni f er S av age, J e s s ic a Thom son , Ji nan Banna , J unilla L ar se n, Ka r e n Camp bell , Ka umudi J os hipura , Kay la de l a Haye , Ken Ong, Ky lie He ske th, L evi e Ka rsse n, L i Ming Wen , Ly nne Daniel s, Ma rgre t h e Rø e d, Ma r i a Brya nt , Ma ribel Ca mpo s Rive r a , M ary J o M e ssi to, M i cha el Goran , N i n a Ø v e rby, Rac h ael Ta ylor , Ra ch el G r o ss, Ra jalak s hmi L ak shman , Ru s s ell Rot hman, S a r a h - Jeann e Sal vy, S harle en O ’ Rei lly, St ephani e Anz ma n -Fra s c a , Ve ra Ve r b e s te l Author s’ c ont ributions ALS togeth er wi t h KEH, BJ J, LA, RK G c onc e ived t he id ea fo r th e study. BJJ, KEH, AL S, RK G, L A deve lop ed th e re s earch que s t i on and p rotoc ol regi st r a t i o n. BJJ wro te th e fi r st dra f t of t he manu scrip t. KEH, BJJ, AL S, RK G, L A deve lop ed th e e lig ibi lity c r iteri a and KH de velop e d th e s ear ch stra te gy. KEH, MA, AB, B JJ, S L, AL S p e r f ormed the s e a r c h and sc r e e ning. BJJ, PC , RKG de velo pe d th e co ding proc e dure. AJH, CT W, CR, D E, DA O ’ C, IC M, KPR, L AB, LPS , L W , MS -S, P C, RWT, ST, SM, W S provi ded critica l revie w an d f eedbac k a t each s tag e of the proce s s . . CC-BY-NC 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint The copyright holder for thisthis version posted December 19, 2020. ; https://doi.org/10.1101/2020.12.17.20248435doi: medRxiv preprint 17 All au thor s c rit i call y r e vi sed th e manu sc ript for in telle c tual c onte nt , a nd a gre ed and approv ed t h e final manu scrip t. B JJ i s th e gua r a n tor o f the manusc ript . Fundi ng st ateme nt This w or k wa s suppo rt ed by t he Au strali a n Nati onal He a lth and M edi cal R ese arch Counc il (N HMRC ) Idea s G ran t TOP CHILD (Tran s forming Ob esi ty Pr eve ntion for CHIL Dren ): Loo king i nt o th e blac k box of interve n t i on s ( GNT11863 63 ). Fund e rs ha d no role in devel o ping thi s pro tocol . Indi vi dual a ut h ors dec lare the fol lowing fundi ng: ALT repor t s fu nding fr om NIH R01H D073237; AM L r eport s fundi ng from N IH N a tion al Cen ter for Adva ncing Transl ation al Sci ence t h r oug h gran t # U L 1TR00011 7 and UL1TR0 01998; BJ T repor ts fun ding fr o m H e alth R e sea rch Counci l o f N ew Z ealan d; CGA rep ort s funding f r o m The P e p s iC o Fo unda ti on; C P repo rt s fund ing fr om Na tional In stitu te s o f Heal th, Rob e r t Wood Jo hn son Fo und ation , World H eal th O rgani z a tion, U S Dep artm ent o f Agricu l t u r e ; COS r e po r t s funding f r o m U ni ver s i t y o f Cinc inn ati Uni v ers i ty Re s ea r c h Counc il ; DA OC i s s uppo r ted by an Aus t ral i an Na tional He alt h and M e dic al R es earch Cou ncil (NHMR C) Tra nsl ating Re s e a r c h into Prac t i c e F ellow s hip (AP P 1168749 ); EO r e p or t s th e PR OBIT stu dy w as s uppor ted b y grant MOP -53155 from th e Ca n adian I nstit ute s o f He alth R es earch and g ra nt R01 H D 0 50758 from t he U S N a t i onal Ins titu t e s o f Hea l t h ; IMP repo rts fu ndin g from gran t R01DK08 8244 f rom the Uni te d S tat es N at iona l Ins titu t e o f Di abe te s and Dig e s tiv e an d Kidney D i sea ses ; J CB re por ts fundi ng from US Depa rtme nt o f Agric ulture ; JKL a nd LTK r e por ts funding f r om Fond s Nuts Ohr a awa r de d (100.93 9) ; JSS repo rt s funding f r o m N I H NI DDK, N IH N HLB I, P C O RI; J L T is an employ e e o f USD A ARS a nd the Agen cy d id fund th e Del t a He althy S pr outs Tria l (Pr oject 6 401-5300 -00 3-00 D); KdlH repo rts f u nding from 1R01HD0924 83-01 (MP I: de l a Hay e, Sa lv y), NIH /NICH D; KDH i s s uppo rt ed by an A ust r a lian Re s ea r c h Counc il F ut u re Fell ow s h i p (FT13 0100637 ) ; LMW re por t s fundin g from NH M RC (#3 9 3112; # 1003780 ; #11 69823); L W i s s u ppor ted by a NHM R C Ca ree r Deve l opmen t and N HF F u ture Lea der F ell ow ship; MB repo rt s HA PPY wa s fun ded b y a UK N IHR Pr ogramme Grant for Applie d R e sea r ch (proje ct numbe r RP -P G-040 7-10044 ); M CR r epor t s The Ba by Ac t T r ia l wa s spo ns ored by t h e Cen ter for Coll abo rative Re s ea r c h in Hea l th Di s pa r it ie s und er gran t U54 MD007600 o f th e Na tional In s ti tut e on Minority He a lt h and H eal t h D i spa riti es fr om the Na tional In s ti tut es of He alth ; MJ M repor t s fun di ng from US DA AFR I 201 1-68001 -302 07; N C Ø r ep o r t s th eir or igina l study wa s p a r tly f unded by the Norwegia n W omen's Publi c Heal th As soc iation , who h ad n o in f l u ence on any pa rt of th e s tudy design , impleme nta t i o n and e valua t i on; RKG is a Chi e f Inve s tigato r on the Ea rly P r ev enti on of Obe s i t y in Chi l dhood, NHMR C C entr e f or Rese arch E xce llenc e (11016 75) ; RSG i s su pported by the Natio nal In s t itu te o f F ood and A g r i cultur e/U S Depa rtme nt o f Agricul t u re, awa rd n u mber 2011- 6800 1-30207, and th e Na tiona l In st i tute s of Heal th/ Na tional I nstit ute o f C hil d Hea lth an d H u man . CC-BY-NC 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint The copyright holder for thisthis version posted December 19, 2020. ; https://doi.org/10.1101/2020.12.17.20248435doi: medRxiv preprint 18 Deve lopm ent t hrough a K23 Men tor ed P a t i en t- O ri ent ed Re s e a r c h C are er D ev elo pment Aw ard (K23HD08107 7; princi p al inv estig at or : R a che l S. Gr os s); RL re por t s funding fr o m UK N PRI ( N a tion al Preve n t i on R es earch I nitia tive) , M R C PHI N D ( Publi c He al t h In t e r v entio n Deve l op ment progr amme ); SL O R r e po r t s fu nding from European Uni ons Ho riz on 2020 Re s e a r c h and I nnovati on Progr amme (Gra nt Agre eme nt no . 8 47984) a nd Au str ali a Na tional H e a lth a nd Med ical R e s e a rch Coun cil (NH MR C ) (G ran t appli cat ion n o. AP P119 42 34); S- JS r e p orts funding f rom NIMHD U 54 MD 00 0502 (MP I: S alvy & D utt on Pr ojec t #2 ), N ICH D R 01HD 09 2483 (M PI: S alvy & de la H a ye ); SA-F i s a c o - inv es t ig ato r on the c u r ren t IN SIG HT gran t w hich follow s part ic ipant s to age s 6 a n d 9: NIH 2R01DK08 8244; AB P-E re port s the S P OO N p r og r a m in Gu at emal a i s fund ed b y th e Int er -Americ a n Deve lopm ent Ba nk with d onati on s of Th e Gov ernm ent o f Ja pan and The Pep si Co Fou ndati on. Competing int e r e s ts state ment Autho rs l i sted a s T r i al R epr es ent ative s a re inves tigato r s of elig ible tri al s. All a utho rs ha ve c ompl ete d the I CMJE u ni fo r m disclo su re f orm at ww w.ic mje.org/coi _di sclo sure .pd f an d decl are: no supp ort from any organi sa tion for the submit ted w or k ; AB, AL S, B JJ, KEH, M A, RKG, S L a nd LPS repor ts gran ts from NHMRC Id ea s G ran t T O P CHIL D (T r a nsforming O b e sity P rev enti on fo r CH ILDr en) ( GN T 118636 3) ; APE a nd C GA re por ts gran ts admini ste re d by the Int er -Ame rican De velopm en t Ba nk f rom T he Governmen t o f J a p an and The P e p s iC o F ounda t i o n; ALT r ep o r t s gran t s from N at i ona l In sti t u te of Health ; BJT re ports gr ant s fr om N Z H e al t h Res earch Council ; EO r e po rts gran t s fro m t h e US Na tional Ins titu t e s o f Hea l t h , an d the C anad ia n In st i tut e s fo r Heal th Re s earc h; IMP repo rt s gran ts fr om NIH/NI DDK; J S S r epor t s g r a nt s from P CO RI, NI H NI D DK a nd NH L BI, an d per s on a l f ee s fro m Dano ne Or g anic , Ame rica n Acad e my of P e diat ric s , and L et s Move Mai ne; LT K and JKL repo rt s g r a nts from Fon ds Nut sOhra ; MCR repo rt s gran t s fr o m National In s ti tut e on Minori ty Heal th a nd Heal th Di spari tie s-Na tiona l In st i tut e s of H ealth / Cen ter for Colla bo r a t i ve Re se arc h in Heal t h D i spa ritie s , and per sonal fe e s from Rhy thm Pharm ac euti cal s ; RS G re ports gr ant s fr om U S D epar tm ent of Agricul t u re and N IH /NICH D; no o the r rela t i on s hi p s o r a ctivitie s th at c ould a ppea r to hav e in fl ue nced th e submit ted work . . CC-BY-NC 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(which was not certified by peer review)preprint The copyright holder for thisthis version posted December 19, 2020. ; https://doi.org/10.1101/2020.12.17.20248435doi: medRxiv preprint