key: cord-0017861-f6r0f269
authors: O'Reilly, Sharleen L.; O'Brien, Eileen C.; McGuinness, Denise; Mehegan, John; Coughlan, Barbara; O'Brien, Denise; Szafranska, Marcelina; Callanan, Sophie; Hughes, Shenda; Conway, Marie C.; Brosnan, Mary; Sheehy, Lucille; Murtagh, Rosie; O'Hagan, Lorraine; Murray, Stephanie; Scallon, Charmaine; Dunn, Elizabeth; Power, Paula; Woodcock, Marie; Carroll, Amy; Corbett, Marie; Walsh, Michelle; Keogh, Regina; McAuliffe, Fionnuala M.
title: Latch On: A protocol for a multi-centre, randomised controlled trial of perinatal support to improve breastfeeding outcomes in women with a raised BMI
date: 2021-04-08
journal: Contemp Clin Trials Commun
DOI: 10.1016/j.conctc.2021.100767
sha: 73682b2bc4015e4afc54eece6578d1ae58dd4978
doc_id: 17861
cord_uid: f6r0f269

INTRODUCTION: Breastfeeding is associated with improved maternal and child outcomes. Women with a higher body mass index (BMI), who comprise about 50% of the population, are at increased risk of poorer breastfeeding practices and are a population who would benefit from breastfeeding. METHODS: This protocol is for a multi-centre, randomised controlled trial of perinatal breastfeeding support among primiparous women with a BMI >25 kg/m(2), using a previously-tested, multi-component intervention. The primary outcome is any breastfeeding at 3 months. The intervention will support mothers and their partners and spans from late pregnancy to six weeks postpartum. Intervention components include group antenatal breastfeeding education, individual face-to-face education in the immediate postnatal period, professional support to six weeks’ postpartum and weekly phone calls in the immediate postpartum period from an International Board Certified Lactation Consultant (IBCLC). The intervention will target attitudes towards breastfeeding, breastfeeding self-efficacy, and subjective norms around infant feeding with the aim to normalise the behaviour. RESULTS: We anticipate that the intervention will be well-accepted and feasible to carry out within four maternity units in the East of Ireland. Furthermore, essential formative qualitative work has been conducted to inform the intervention design and to ensure that it is contextually appropriate. CONCLUSION: The proposed intervention will be invaluable to policy-makers in providing insights into what specific interventions are effective in improving breastfeeding rates for women with a raised BMI.

Br ea st fe ed in g pr o vi de s op ti ma l nu tr i ti on fo r in fa nt s an d ch il dr en fr om bi rt h to tw o ye ar s an d be yo nd [ 1 ] . Fo r a wo ma n, th e be n e fi ts incl ud e su p po rt in g he r in re tu rn in g to he r pr e -pr eg na nc y bo dy ma ss in de x (B MI ), be t te r pr eg na nc y sp ac in g, an d a lo we r ri sk of br ea st ca n ce r an d di a be te s la te r in li fe [ 2 ] . Th e in fa nt be n e fi ts in cl ud e lo we r lo ng -te rm ri sk of de ve l op in g ob e si ty an d ty pe 2 di a be te s [ 2 ] . Wi de r co m mu ni ty be n e fi ts of in cr ea se d br ea st fe ed in g ar e ga in ed th ro ug h in cr ea se d pa r en t pr e se n te ei sm at wo rk an d lo ng er te rm be t te r he al th in th e wo ma n [ 2 ] .

Ir is h br ea st fe ed in g ra te s ar e am on gs t th e lo w es t wo rl d wi de [ 2 , 3 ] wi th on ly 60 % of Ir is h ne w bo rn s re ce iv in g an y br ea st mi lk an d of th at pe rce nt ag e, 50 % ar e ex cl u si ve ly br ea st fe d on di s ch ar ge fr om th e ma te r ni ty se r vi ce s [ 4 ] . Ot he r de ve l op ed co un tr ie s su ch as Au s tr al ia , ha ve 96 % br ea st fe ed in g on di s ch ar ge an d ex cl u si v it y ra te s of 62 % at fo ur mo nt hs [ 5 ] . He al th pr o mo ti on st ra te gi es ar e in pl ac e to su p po rt in cr ea se d br ea st fe ed in g an d th e Ir is h Na ti on al Br ea st fe ed in g Ac ti on pl an do c ume nt s th e ne ed fo r a 2% ye ar -on -ye ar in cr ea se in an y br ea st fe ed in g if an y pr og re ss is to oc cu r [ 6 ] .

Wo me n wi th ov er we ig ht or ob e si ty ar e an id en ti fi ed po p u la ti on su bgr ou p th at ha ve lo w br ea st fe ed in g su c ce ss [ 7 ] . Wh il e br ea st fe ed in g in iti a ti on ra te s in wo me n wi th a ra is ed BM I ar e 13 % lo we r th an wo me n wi th a he al th y BM I [ 7 ] , th e dr op of f is st ee p on ce br ea st fe ed in g ha s st ar te d. Wo me n wi th ov er we ig ht or ob e si ty ar e 76 % an d 83 % le ss li ke ly to be BF at 6 we ek s an d 6 mo nt hs , re sp ec ti ve ly , co m pa re d to wo me n wi th a he al th y BM I [ 8 ] . Su c ce ss fu l mu l ti fa c et ed br ea st fe ed in g su p po rt in te r ve n ti on el e me nt s in cl ud e: he al th pr o fe s si on al -le d ed u ca ti on , no nhe al th pr o fe s si on al -le d co un se ll in g an d pe er su p po rt in te r ve n ti on s [ 9 ] . In te r ve n ti on s em be d de d in to st an da rd ca re ; on go in g sc he d ul ed po st pa rtu m vi s it s; ta i lo re d in te r ve n ti on s to po p u la ti on ne ed s; in te r ve n ti on s deli v er ed by he al th pr o fe s si on al or pe er s or a mi x of bo th ; an d fa ce -to -fa ce su p po rt im pr ov ed lo ng er te rm br ea st fe ed in g ou t co me s [ 10 ] . A re ce nt pi lo t of a mu l ti di me n si on al br ea st fe ed in g in te r ve n ti on wa s su c ce ss fu ll y ca r ri ed ou t am on g 10 0 wo me n, re p re se nt in g al l we ig ht cl as si fi ca ti on s, at Th e Na ti on al Ma te r ni ty Ho s pi ta l, Du bl in an d We x fo rd Ge n er al Ho s pita l, We x fo rd [ 11 , 12 ] . Pr im i pa ro us wo me n re ce iv ed an an te na ta l gr ou p ed u ca ti on cl as s, a on e -to -on e In te r na ti on al Bo ar d Ce r ti fi ed La c ta ti on Co n su l ta nt (I B CL C) co n su l ta ti on af te r bi rt h an d ac ce ss to on li ne re -so ur ce s, fo l lo w -up ph on e ca ll s fr om an IB CL C, an d a br ea st fe ed in g su ppo rt gr ou p. Th e in te r ve n ti on fo un d ex cl u si ve br ea st fe ed in g at 3 mo nt hs wa s in cr ea se d co m pa re d to na ti on al pr ev a le nc e, we ll -ac ce pt ed an d fe asi bl e to ca rr y ou t in bo th ur ba n an d ru ra l ar ea s [ 11 ] . Th e pi lo t id en ti fi ed th at mo th er s wi th a BM I > 25 kg / m 2 we re le ss li ke ly to ex cl u si ve ly br ea st fe ed at 3 mo nt hs [ 12 ] an d we re a po te n ti al ly im po r ta nt su bgr ou p to ta r ge t wi th in a fu ll y po w er ed ra n do mi se d tr ia l.

Th is st ud y ai ms to in ve s ti ga te th e ef fe c ti ve ne ss of a mu l ti co m po ne nt br ea st fe ed in g su p po rt in te r ve n ti on on th e pr ev a le nc e of an y br ea st fe edin g at 3 mo nt hs am on g wo me n wi th a BM I > 25 kg / m 2 . It is hy po th esi se d th at wo me n in th e in te r ve n ti on gr ou p wi ll ha ve hi gh er pr ev a le nc e of br ea st fe ed in g in i ti a ti on , lo ng er br ea st fe ed in g du ra ti on an d hi gh er br ea st fe ed in g se lf -ef fi ca cy th an th os e in th e co n tr ol gr ou p. It is al so anti c i pa te d th at th e in cl u si on of th e su p po rt pa rt ne r wi ll im pr ov e th e su ppo rt -st ru ct ur e fo r wo me n in th ei r ho me se t ti ng .

La tc h On is a mu l ti ce n tr e ra n do mi se d cl in i ca l tr ia l to te st th e ef fe cti ve ne ss of an ed u ca ti on an d su p po rt in te r ve n ti on pr o gr am , fo r wo me n wi th ov er we ig ht or ob e si ty , du r in g pr eg na nc y an d th e fi rs t si x we ek s po st na ta l on in cr ea s in g br ea st fe ed in g pr ev a le nc e at th re e mo nt hs po stpa r tu m. Th e fl ow of pa r ti c i pa nt s th ro ug h th e st ud y fr om re cr ui t me nt to co m pl e ti on is il lu s tr at ed in Fi g. 1 . Et h i ca l ap pr ov al wa s gr an te d by Nati on al Ma te r ni ty Ho s pi ta l Et hi cs Co m mi t te e in De ce m be r 20 18 (r ef : EC .2 4. 20 18 ). Th e tr ia l wa s pr os pe c ti ve ly re g is te re d (I S RC T -Fi g. 1 . Fl ow ch ar t fo r Th e La tc h On St ud y; *r e cr ui t me nt an d in te r ve n ti on im pa ct ed by co vi d -19 pa n de mi c: Ma rc h 12 th , 20 20 un ti l pr e se nt (A pr il 20 20 , an d li ke ly th is wi ll be th e ca se un ti l re cr ui t me nt is co m pl et ed ); fa ce -to -fa ce re cr ui t me nt di d no t co n ti nu e du r in g th is pe ri od , fa ce -to -fa ce an te na ta l cl as se s we re al so su spe nd ed du r in g th is ti me wi th on li ne cl as se s of fe re d as an al te r na ti ve . Dr op -in cl in ic s we re av ai l ab le by ap po in t me nt on ly . N1 48 19 65 0) , in i ti al pl an ni ng st ar te d on Au gu st 1 st , 20 18 an d re cr ui tme nt co m me nc ed on Ju ne 4 th , 20 19 . Re cr ui t me nt fr om Ma rc h 12 th , 20 20 to da te (A pr il 20 21 ) ha s be en im pa ct ed by th e co vi d -19 pa n de mi c. Th e NM H, ba se d in th e ci ty ce n tr e of Du bl in , Ir e la nd 's ca p i ta l, is on e of th e la rg es t ma te r ni ty ho s pi ta ls in Eu ro pe wi th ap pr ox . 90 00 bi rt hs pe r ye ar . WG H is a sm al le r re gi on al ho s pi ta l in We x fo rd , Ir e la nd , wi th ap pr ox i ma te ly 20 00 ba bi es de li v er ed ea ch ye ar . Si m i la rl y, SL K an d MR H ar e re gi on al ho s pi ta ls wi th ap pr ox i ma te ly 16 00 an d 19 00 bi rt hs ea ch ye ar re sp ec ti ve ly .

Re cr ui t me nt st ra te gi es va ry du e to si te -le ve l di f fe r en ce s in st af fi ng , ca re de li v er y an d ti m in g of ro u ti ne vi s it s an d in cl ud e re cr ui t me nt wi th in an te na ta l cl in ic s, wi th re se ar ch er s or mi d wi ve s ap pr oa ch in g wo me n in ea rl y pr eg na nc y to th e be gi n ni ng of th e th ir d tr im es te r. Po st er s ar e di s pl ay ed th ro ug h ou t ho s pi ta l ma te r ni ty un it s an d on ho s pita l we b si te s. So ci al me di a, in cl ud in g Tw it te r an d In st a gr am ar e al so us ed as a re cr ui t me nt ch an ne l. At al l si te s, li st s of th e re a so ns fo r re fu sa l to ta ke pa rt in th e st ud y ar e do c u me nt ed to ke ep a re co rd of wh y pa r ti ci pa nt s di d no t wi sh to ta ke pa rt . Wo me n we re al so fr ee to de cl in e pa r ti ci pa t in g wi th ou t pr o vi d in g an ex pl a na ti on .

Th e CO VI D -19 pa n de mi c em er ge d du r in g th e st ud y an d re cr ui t me nt wa s ad ap te d. Pa r ti c i pa nt s re cr ui te d be tw ee n Ju ne 4 th , 20 19 an d Ma rc h 12 th , 20 20 we re en ro ll ed pr io r to co vi d -19 (n = 10 5) ; al l pa r ti c i pa nt s re cr ui te d af te r 12 th Ma rc h 20 20 we re en ro ll ed du r in g th e co vi d -19 pa nde mi c. St af f we re li m it ed in th e ti me th ey co ul d al lo ca te to as si st wi th th e st ud y du r in g th e pa n de mi c, an d th er e fo re re cr ui t me nt wa s ma in ly vi a se lf -re fe rr al fr om in -ho us e no ti ce s an d ho s pi ta l we b si te s, wi th pr egna nt wo me n in te r es te d in th e st ud y co n ta ct in g th e re se ar ch te am ab ou t pa r ti c i pa t in g. Re cr ui t me nt st ra te gi es we re ad ap te d wi th fa ce -to -fa ce recr ui t me nt in an te na ta l cl in ic s re du ce d. At th e NM H, th e st ud y wa s pu bli ci se d in an te na ta l cl in ic s vi a po st er s, th ro ug h so ci al me di a su ch as Tw it te r an d In st a gr am , an d al so pr o mo te d at on li ne an te na ta l cl as se s. Th e ch ar ts of wo me n at te nd in g an te na ta l cl in ic s ar e no w sc re en ed by re se ar ch er s fo r el i gi bi l it y, an d th os e de em ed el i gi bl e su b se qu en tl y co nta ct ed vi a ph on e an d pr o vi de d wi th ve r ba l in fo r ma ti on on th e st ud y. If th ey ar e in te r es te d in ta k in g pa rt , fu r th er in fo r ma ti on an d co n se nt fo rm s ar e se nt to th em vi a em ai l. At th e re gi on al ho s pi ta l si te s, th e st ud y wa s al so pu b li ci se d vi a po st er s, th ro ug h so ci al me di a, an d pr omo te d at on li ne an te na ta l cl as se s. Re cr ui t me nt ph on e ca ll s we re al so ad ap te d at th es e si te s wh er e po s si bl e.

Fa ce -to -fa ce an te na ta l cl as se s we re mo ve d to on li ne vi r tu al cl as se s wi th fo l lo w -up ph on e ca ll s of fe re d as an al te r na ti ve . Po st na ta l 1 -1 co nsu lt s we re po s si bl e wi th IB CL C' s at ea ch ho s pi ta l si te . Po st na ta l br ea stfe ed in g dr op -in cl in ic s we re al so ca n ce ll ed , an d th es e cl in ic s we re inst ea d of fe re d by ap po in t me nt on ly .

An ou t li ne of th e PI CO (p op u la ti on , in te r ve n ti on , co m pa r i so n, ou tco me s) fo r th e La tc h On St ud y is in cl ud ed in Ta bl e 1 .

De pe nd in g on th e se t ti ng , el ec tr on ic he al th re co rd s or tr a di ti on al pa pe r ch ar ts ar e us ed to sc re en wo me n fo r el i gi bi l it y in ad va nc e of wo me n at te nd in g th ei r an te na ta l ap po in t me nt . In fo r ma ti on on ge n er al so ci od e mo gr ap h ic s, ge s ta ti on al ag e, re pr o du c ti ve hi s to ry an d pr e -an d ea rl y ge s ta ti on al we ig ht ga in wi ll be ob ta in ed th ro ug h in te r vi ew wi th th e pa r ti c i pa nt .

Ta bl e 1 PI CO (p op u la ti on , in te r ve n ti on , co m pa r i so n, ou t co me s) fo r th e La tc h On St ud y.

In cl us io n cr it er ia • Pr im ip ar ou s wo me n • Si ng le to n pr eg na nc y • BM I ≥2 5 kg /m 2 at bo ok in g vi si t • Ag e ≥1 8 ye ar s • Go od un de rs ta nd in g of En gl is h • Ab il it y to gi ve in fo rm ed co ns en t • Ha ve a su pp or t pa rt ne r av ai la bl e an d wi ll in g to pa rt ic ip at e if in in te rv en ti on gr ou p Ex cl us io n cr it er ia • Pr et er m (< 37 we ek s' ge st at io n) de li ve ry • An y co nd it io n re qu ir in g me di ca ti on th at is co nt ra in di ca te d fo r br ea st fe ed in g In te rv en ti on In te rv en ti on co mp on en ts in cl ud e:

• Gr ou p an te na ta l ed uc at io n fo r pr os pe ct iv e mo th er s an d th ei r su pp or t pa rt ne rs 

Wo me n ar e el i gi bl e if th ey ar e ag ed 18 or ol de r, ar e id en ti fi ed as ha v in g a BM I of 25 kg / m 2 or hi gh er at th ei r fi rs t an te na ta l vi si t; pr im ipa ra ; si n gl e to n pr eg na nc y; 26 -34 we ek s pr eg na nt at re cr ui t me nt ; pr o fici en t in En g li sh ; ab le to gi ve in fo rm ed co n se nt ; ha ve an id en ti fi ab le su p po rt pa rt ne r av ai l ab le , an d ar e wi ll in g to pa r ti c i pa te in th e tr ia l. Su p po rt pa rt ne rs co ul d be th e ba by 's fa th er , th e pr eg na nt wo m an 's ma le or fe ma le pa rt ne r, th e pr eg na nt wo m an 's mo th er or si s te r or a tr us te d fr ie nd .

Pr et er m de li v er y (< 37 we ek s' ge s ta ti on ) an d an y kn ow n/ id en ti fi ed br ea st fe ed in g co n tr ai nd i ca ti on s, in cl u si ve of an y co n di ti on s re qu ir in g me d ic a ti on co n tr ai nd i ca te d fo r br ea st fe ed in g.

Wh en wo me n ar e ap pr oa ch ed , ei th er in pe r so n or vi a ph on e ca ll s, th e st ud y pr o to co l is ex pl ai ne d to th em an d th ey ar e as ke d if th ey ar e inte r es te d in ta k in g pa rt . Pa r ti c i pa t in g wo me n ar e as ke d to pr o vi de si gn ed in fo rm ed co n se nt wi th in th e sa me cl in ic vi si t if po s si bl e wh en recr ui t me nt is in pe r so n. If th ey wo ul d li ke mo re ti me to co n si de r th e st ud y, th ey ar e gi ve n ti me to re vi ew st ud y in fo r ma ti on an d a co n se nt fo rm to co m pl et e an d re tu rn to re se ar ch er s. Re se ar ch er s sc he d ul e a fo llo w -up ph on e ca ll fo r 2 -3 da ys af te r th is .

Wo me n ar e al lo ca te d to ei th er in te r ve n ti on or co n tr ol us in g a co mpu te r -ge ne ra te d sc he me . Ra n do mi sa ti on is a 1: 1 al lo ca ti on an d st ra t ifi ed by st ud y si te an d BM I ca t e go ry (C ST AR , UC D) . Gi ve n th e na tu re of th e in te r ve n ti on , ne i th er th e pa r ti c i pa nt s no r th e re se ar ch er s ar e bl in de d to al lo ca ti on . Se al ed op aq ue en ve lo pe s wi ll be se qu en ti al ly nu m be re d an d tr ea t me nt wi ll be al lo ca te d au to ma t i ca ll y th ro ug h se le cti on of th e ne xt av ai l ab le en ve lo pe . Re se ar ch er s se le ct a se al ed en velo pe in nu me r i ca l or de r, op en th e en ve lo pe an d wi ll th en ad vi se th e wo ma n of th e gr ou p th ey ha ve be en al lo ca te d to . Wo me n re ce iv e a ph on e ca ll af te r th ey ha ve pr o vi de d co n se nt to ta ke pa rt in th e st ud y.

Wo me n as si gn ed to th e co n tr ol gr ou p ar e pr o vi de d wi th or al an d wr it te n in fo r ma ti on on an te na ta l an d po st na ta l su p po rt fo r br ea st fe edin g th at is av ai l ab le in th e st ud y si te ho s pi ta l an d co m mu ni ty , an d wi ll re ce iv e ro u ti ne an te na ta l ca re . A su m ma ry of th e in fo r ma ti on av ai l ab le to wo me n in th e co n tr ol gr ou p is av ai l ab le in Ap pe n di x A.

Th is mu lt i -co mp on en t in te r ve n ti on ta r ge ts pr os pe c ti ve mo th er s an d th ei r su p po rt pa rt ne rs an d sp an s th e pe ri na ta l pe ri od fr om la te pr egna nc y to si x we ek s' po st pa r tu m. In te r ve n ti on co m po ne nt s in cl ud e gr ou p an te na ta l ed u ca ti on fo r pr os pe c ti ve mo th er s an d th ei r su p po rt pa rt ne rs , in di vi d ua l ed u ca ti on fo r ne w mo th er s in th e im me di at e po stna ta l pe ri od , an d pr o fe s si on al su p po rt fo r ne w mo th er s to si x we ek s po st pa r tu m ( Ta bl e 2 ). Wo me n al lo ca te d to th e in te r ve n ti on gr ou p atte nd a gr ou p an te na ta l ed u ca ti on se s si on us u al ly be tw ee n 28 -36 we ek s ge s ta ti on wi th th ei r su p po rt pa rt ne r.

In te r ve n ti on ap pr oa ch es us ed . Re se ar ch er s wi ll ph on e pa rt ic ip an ts to ra nd om is e th em to a st ud y gr ou p, an d al so to sc he du le th e an te na ta l cl as s an d to gi ve re mi nd er s ab ou t co mp le ti ng th e on li ne qu es ti on na ir es . Ph on e ca ll s fr om re se ar ch er to pa rt ic ip an ts oc cu r fo r bo th th e in te rv en ti on an d co nt ro l gr ou ps .

Th ro ug ho ut th e st ud y Gr ou p ed uc at io n An te na ta l cl as sth e an te na ta l cl as s co ve rs a ra ng e of to pi cs in re la ti on to br ea st fe ed in g ra te s, th e be ne fi ts of br ea st fe ed in g, th e ba si cs of br ea st fe ed in g, an d br ea st fe ed in g su pp or t. Th e an te na ta l cl as se s ar e de li ve re d by la ct at io n co ns ul ta nt s. Pr eg na nt wo me n an d th ei r su pp or t pa rt ne rs ar e re qu ir ed to at te nd th e an te na ta l cl as s.

In te rv en ti on gr ou p on ly .

28 -36 we ek s

In di vi du al co ns ul ta ti on IB CL C wi ll pr ov id e fa ce to fa ce ad vi ce an d su pp or t af te r th e bi rt h of th e in fa nt . In te rv en ti on gr ou p on ly .

Ph on e ca ll fr om IB CL C IB CL C wi ll ph on e mo th er we ek ly to di sc us s he r pr og re ss an d is su es sh e is ha vi ng . Se lf -ef fi ca cy pr om pt s. In te rv en ti on gr ou p on ly .

On ce pe r we ek fo r 6 we ek s po st pa rt um Br ea st fe ed in g su pp or t gr ou p cl in ic IB CL C le d dr op -in we ek ly cl in ic ma de av ai la bl e to mo th er s fo r th e fi rs t 6 we ek s po st pa rt um .

In te rv en ti on gr ou p on ly . Br ea st fe ed in g su pp or t cl in ic is by ap po in tm en t on ly du ri ng th e co vi d -19 pa nd em ic .

On ce pe r we ek fo r 6 we ek s po st pa rt um Du r in g th e co vi d -19 pa n de mi c (f ro m 12 th Ma rc h 20 20 on wa rd s) , ch an ge s to th e pr o vi si on of th e in te r ve n ti on co m po ne nt s we re ma de . Al l an te na ta l cl as se s no w ta ke pl ac e vi r tu al ly , an d po st na ta l dr op -in cl in ic s ar e no w ta k in g pl ac e by ap po in t me nt on ly . Wo me n re ce iv e po st na ta l fo l lo w -up su p po rt ov er th e ph on e fr om la c ta ti on co n su l ta nt s fo r th e fi rs t 6 we ek s po st pa r tu m, wi th an in -pe rs on ap po in t me nt ar ra ng ed if ne ed ed or re qu es te d.

Th e in te r ve n ti on ha s be en ma pp ed on to th e CO M -B be ha v io ur ch an ge fr am e wo rk wi th a fo cu s on at ti tu de s to br ea st fe ed in g, ch an g in g su b je c ti ve no rm s an d pe r ce iv ed be ha v io ur al co n tr ol ( Ap pe nd ix B ). At titu de s to wa rd br ea st fe ed in g ar e ta r ge te d by pr o vi d in g ed u ca ti on in th e an te na ta l an d po st na ta l pe ri od to mo th er s an d th ei r su p po rt pa rt ne rs . Su b je c ti ve no rm s ar ou nd in fa nt fe ed in g ar e ta r ge te d by pr o vi d in g ed uca ti on to th e pr eg na nt wo m an 's su p po rt pa rt ne r, an d by fa ci l i ta t in g br ea st fe ed in g su p po rt gr ou ps po st pa r tu m wh ic h wi ll be at te nd ed by ot he r br ea st fe ed in g mo th er s, no r ma l is in g th e be ha v io ur . Th e mo th er 's pe r ce iv ed be ha v io ur al co n tr ol of he r ab il it y to fe ed he r ba by (b re as tfe ed in g se lf -ef fi ca cy ) is ta r ge te d by pr o vi d in g an te na ta l an d po st na ta l ed u ca ti on th at is re al is ti c an d de sc ri be s wh at to ex pe ct wh en br ea stfe ed in g, in cl ud in g po te n ti al ch al le ng es th at ma y ar is e an d ho w to ma nag e th es e ch al le ng es . Th is ed u ca ti on eq ui ps wo me n wi th th e sk il ls an d co n fi de nc e to ma n ag e br ea st fe ed in g, in cr ea s in g th ei r se lf -ef fi ca cy .

Pr eg na nt wo me n an d th ei r su p po rt pa rt ne rs ar e as ke d to at te nd an an te na ta l cl as s at 28 -36 we ek s ge s ta ti on . Th is cl as s co v er s a ra ng e of to p ic s in re la ti on to br ea st fe ed in g ra te s, th e be n e fi ts of br ea st fe ed in g, th e ba si cs of br ea st fe ed in g, an d br ea st fe ed in g su p po rt . Th e an te na ta l cl as se s ar e de li v er ed by la c ta ti on co n su l ta nt s. At te n da nc e at th e an te nata l cl as s is co m pu l so ry fo r th e su p po rt pa rt ne r an d th ey wi ll be pr o vi de d wi th sp e ci fi c in fo r ma ti on on ho w th ey ca n su p po rt th e br ea st fe ed in g mo th er . Al l su p po rt pa rt ne rs we re en co ur ag ed to at te nd th e cl as s; ho wev er , if a su p po rt pa rt ne r wa s un ab le to at te nd , th is wa s re co rd ed an d th ey we re pr o vi de d wi th in fo r ma ti on to re ad th ro ug h in th ei r ow n ti me , or a se c on d an te na ta l cl as s wa s ar ra ng ed fo r a ti me th e pa rt ne r co ul d atte nd . A co py of th e an te na ta l cl as s ch ec k li st is in cl ud ed in Ap pe nd ix C , wh ic h ou t li ne s th e co n te nt co v er ed at th e cl as s.

Af te r th e bi rt h of th e in fa nt , an IB CL C pr o vi de s th e pa r ti c i pa nt wi th fa ce -to -fa ce ad vi ce an d su p po rt . Th e IB CL C co v er s as pe ct s su ch as br ea st as se ss me nt , in fa nt or al as se ss me nt , wh at to ex pe ct in th e fi rs t fe w da ys , ho w to at ta ch an d re co g ni se th e ba by is ef fe c ti ve ly fe ed in g, as we ll as ot he r el e me nt s su ch as en su r in g a mi n i mu m of 8 fe ed s pe r 24 h, an d kn ow in g ho w to ha nd ex pr es s. De ta il s of ne w bo rn fe ed in g me th od ar e co l le ct ed at th is fa ce -to -fa ce se s si on an d a br ea st fe ed in g as se ss me nt is co m pl et ed by th e IB CL C. An y ot he r is su es or ch al le ng es ar e al so asse ss ed at th is se s si on . Fi na ll y, a LA TC H as se ss me nt is co m pl et ed by th e IB CL C. Th e po st na ta l as se ss me nt ch ec k li st ( Ap pe nd ix D ) gi ve s de ta il s of wh at is co v er ed at th is ed u ca ti on se s si on . Th e pr ef er en ce is fo r an inpe rs on co n su l ta ti on wi th an IB CL C. If a mo th er is di s ch ar ge d pr io r to a la c ta ti on re vi ew th ey re ce iv e a te le ph on e co n su lt as so on as po s si bl e afte r di s ch ar ge . Vi de o ca ll s ar e al so ar ra ng ed if re qu ir ed . A no te of ho w 1 -2 -1 co n su l ta ti on s we re de li v er ed to pa r ti c i pa nt s is re co rd ed .

Be fo re th e co vi d -19 pa n de mi c, dr op -in cl in ic s we re of fe re d in a gr ou p se t ti ng to al l pa r ti c i pa nt s al lo ca te d to th e in te r ve n ti on gr ou p at th ei r ma te r ni ty un it . Th e ag e of th e ba by , re l e va nt me d ic al an d br ea stfe ed in g hi s to ry an d in fo r ma ti on on an y br ea st fe ed in g ch al le ng es we re di s cu ss ed at th is dr op -in cl in ic . Se lf -ef fi ca cy an d a la tc h as se ss me nt ar e al so co m pl et ed an d no te s of a pl an an d fo l lo w -up ar e re co rd ed wh er e re l e va nt . Dr op -in cl in ic s ar e by ap po in t me nt on ly du r in g th e co vi d -19 pa n de mi c, or a vi de o ca ll ar ra ng ed if th ey ca n no t at te nd in pe r so n. A dr op -in cl in ic ch ec k li st ca n be fo un d in Ap pe nd ix E .

Ed u ca ti on is re in fo rc ed by we ek ly ph on e ca ll s in th e po st pa r tu m peri od fr om an IB CL C to an sw er an y qu es ti on s. Th e IB CL C di s cu ss es th e wo m an 's pr og re ss an d an y is su es sh e ma y be ha v in g. Th e la c ta ti on co nsu l ta nt re co rd s de ta il s in re la ti on to br ea st fe ed in g hi s to ry , an d al so no te s an y br ea st fe ed in g ch al le ng es th at we re di s cu ss ed wi th th e pa r ti c ipa nt . Se lf -ef fi ca cy of th e mo th er is al so pr om pt ed , an d no te s fo r a pl an an d fo l lo w -up re co rd ed wh er e re l e va nt . A fo l lo w -up ph on e ca ll ch ec kli st is in cl ud ed in Ap pe nd ix F . 

Th e se c on da ry ou t co me s in cl ud e: 

Ex it in te r vi ew s wi ll be co n du ct ed wi th bo th wo me n an d th ei r pa rtne rs (w he re av ai l ab le ) to ex pl or e ba r ri er s an d en ab le rs to en ga g in g in th e in te r ve n ti on . Th e in te r vi ew s wi ll be se mi -st ru ct ur ed an d th e CO M -B fr am e wo rk wi ll be ap pl ie d to th e da ta an al y si s. Th e no r ma l iz a ti on of th e in te r ve n ti on in to ro u ti ne pr ac ti ce wi ll be ex pl or ed us in g th e NO MA D qu es ti on na ir e pr e -an d po st -in te rv en ti on [ 15 ] . A fo cu s gr ou p wi ll be co n du ct ed at th e co m pl e ti on of th e st ud y to ex pl or e IB CL C pe r sp ec ti ve s on th e su s ta in ab il it y of th e in te r ve n ti on an d co n te x tu al fa c to rs in vo lv ed in de li v er y.

In 20 17 , pr ev a le nc e of an y br ea st fe ed in g at 3 mo nt hs wa s 38 .6 % in Co m mu ni ty He al th Or ga n i sa ti on 5 (C HO 5) (S LK an d WG H ar e wi th in th is CH O) ; 32 .4 % in CH O8 (M RH is wi th in th is CH O) an d 37 .3 -45 .7 % in CH O 6, 7 an d 9 (c at ch me nt ar ea fo r NM H) . Fo l lo w in g ou r pi lo t st ud y, 60 -70 % of wo me n ha d an y br ea st fe ed in g at 3 mo nt hs [ 11 ] . Gi ve n th at th e wo me n in th is st ud y wi ll al l ha ve a BM I > 25 (l es s li ke ly to br ea stfe ed ), bu t wi ll vo l un te er fo r a br ea st fe ed in g re se ar ch st ud y (m or e li ke ly to br ea st fe ed ), we an ti c i pa te th at th e ba se li ne br ea st fe ed in g ra te wi th in th e co n tr ol gr ou p wo ul d be ap pr ox i ma te ly 40 % at 3 mo nt hs ' po st pa rtu m. Th is es ti ma te is de ri ve d fr om a pi lo t st ud y co n du ct ed in Th e Nati on al Ma te r ni ty Ho s pi ta l, Du bl in fr om Fe b ru ar y to Ju ly 20 16 , an d in We x fo rd Ge n er al Ho s pi ta l, We x fo rd fr om Ju ly to No ve m be r 20 16 . We an ti c i pa te th at th e in te r ve n ti on wi ll in cr ea se br ea st fe ed in g at 3 mo nt hs to 60 -70 %. We ba se d ou r sa m pl e si ze ca l cu la ti on on an un co r re ct ed Pe ar so n ch i -sq ua re te st of th e pr i ma ry hy po th e si s at th e 0. 05 le ve l wi th 80 % po we r us in g th e PS Po we r an d Sa m pl e Si ze pa ck ag e (C ST AR , UC D) . To ob se rv e an in cr ea se in pr ev a le nc e fr om 40 to 60 %; we es tima te th at 19 4 wo me n wo ul d be re qu ir ed to ha ve 80 % po we r to de te ct th is ef fe ct si ze at a si g ni f i ca nc e of 0. 05 , th at is , 97 in ea ch ar m. To obse rv e an in cr ea se in pr ev a le nc e fr om 50 to 70 %; we es ti ma te th at 18 6 wo me n wo ul d be re qu ir ed to ha ve 80 % po we r to de te ct th is ef fe ct si ze at a si g ni f i ca nc e of 0. 05 , th at is , 93 in ea ch ar m. To al lo w fo r dr op ou ts , an d al lo w in g fo r th e bl oc k ra n do mi sa ti on pr o ce du re st ra t i fi ed by si te , we ca l cu la te d th e re qu ir ed sa m pl e si ze wi ll in vo lv e re cr ui t in g 22 0 wo me n ac ro ss th e fo ur ho s pi ta l si te s.

Th e pr i ma ry an al y si s of th e tr ia l wi ll co m pr is e of a co m pa r i so n of th e pr i ma ry en d po in t us in g a lo gi s ti c re gr es si on mo de l, st ra t i fi ed by si te . A co n cl u si on of ef fi ca cy wi ll be de te r mi ne d by a st a ti s ti ca ll y si g ni fi ca nt ef fe ct at a 0. 05 le ve l on th e in te r ve n ti on co ef fi ci en t. Th e pr e di ct ed ab so lu te pr ob a bi l i ti es of an y br ea st fe ed in g, an d an od ds ra ti o fo r th e inte r ve n ti on ef fe ct wi ll be pr e se nt ed , ov er al l an d by si te , wi th 95 % co n fide nc e in te r va ls . As a se n si ti v it y an al y si s, a ra n do m ef fe ct s lo gi s ti c mo de l wi ll be fi t te d wi th a ra n do m in te r ce pt pe r si te to al lo w fo r a di str i b u ti on of ba se li ne ra te s; ho w ev er , we ex pe ct th e sm al l nu m be r of si te s wi ll be in ad e qu at e fo r st a bl e or pr e ci se va ri an ce co m po ne nt es tima te s of th is pa ra me te r, an d it re ma in s a se c on da ry se n si ti v it y an al y si s.

Th is is on e of th e fe w ra n do mi se d co n tr ol le d tr i al s de si gn ed to impr ov e br ea st fe ed in g ou t co me s in wo me n wi th ob e si ty an d ov er we ig ht by in te r ve n in g bo th in th e an te na ta l an d po st na ta l pe ri od s. Th e mu l tifa c et ed ap pr oa ch ha s be en ma pp ed on to th e CO M -B be ha v io ur ch an ge fr am e wo rk [ 16 ] an d re fl ec ts be st pr ac ti ce in co m pl ex im pl e me n ta ti on st ud y de si gn [ 17 ] . Th e co vi d -19 pa n de mi c re su lt ed in ch al le ng es to recr ui t me nt an d pr o vi si on of th e st ud y; ho w ev er , ad ap ta ti on s we re ma de to th e pr o to co l to al lo w th e st ud y to pr o ce ed . 

Su p pl e me n ta ry da ta to th is ar ti cl e ca n be fo un d on li ne at ht tp s: // do i. or g/ 10 . 10 16 / j. co nc tc . 20 21 . 10 07 67 .

Wo rl d He al th Or ga ni sa ti on an d UN IC EF , WH O | Gl ob al St ra te gy fo r In fa nt an d Yo un g Ch il d

Pi wo z , J. C. Ma rt in es , L. Ri ch te r , Br ea st fe ed in g in th e 21 st ce nt ur y: ep id em io lo gy , me ch an is ms , an d li fe lo ng ef fe ct

Eu ro pe an Pe ri na ta l He al th Re po rt , Th e he al th an d ca re of pr eg na nt wo me n an d ba bi es in Eu ro pe in 20 10

Pe ri na ta l St at is ti cs Re po rt 20 16 , He al th ca re Pr ic in g Of fi ce

Au st ra li an Bu re au of St at is ti cs , Na ti on al He al th Su rv ey , Fi rs t Re su lt s Au st ra li a

Br ea st fe ed in g in a he al th y Ir el an d -HS E ac ti on pl an 20 16 -20 21 13 20 17 . ht tp s: // ww w. br ea st fe ed in g. ie / Up lo ad s/ br ea st fe ed in g -in -a -he al th yir el an d

Re du ce d br ea st fe ed in g ra te s am on g ob es e mo th er s: a re vi ew of co nt ri bu ti ng fa ct or s, cl in ic al co ns id er at io ns an d fu tu re di re ct io ns

Th or nb ur g , Im pa ct of ma te rn al ob es it y an d br ea st fe ed in g in te nt io n on la ct at io n in te ns it y an d du ra ti on , Ma te rn

Re vi ew ) Su mm ar y of fi nd in gs fo r th e ma in co mp ar is on , Co ch ra ne Da ta ba se Sy st

Su pp or t fo r he al th y br ea st fe ed in g mo th er s wi th he al th y te rm ba bi es , Co ch ra ne Da ta ba se Sy st

A fe as ib il it y st ud y of a mu lt id im en si on al br ea st fe ed in g -su pp or t in te rv en ti on in Ir el an d , Mi dw if er y 58

An te na ta l br ea st fe ed in g se lf -ef fi ca cy an d br ea st fe ed in g ou tc om es am on g mo th er s pa rt ic ip at in g in a fe as ib il it y br ea st fe ed in g -su pp or t in te rv en ti on

Ra sm us se n , De ve lo pm en t, co ns tr uc t va li di ty , an d re li ab il it y of th e qu es ti on na ir e on in fa nt fe ed in g: a to ol fo r me as ur in g co nt em po ra ry in fa ntfe ed in g be ha vi or s

Th e br ea st fe ed in g se lf -ef fi ca cy sc al e: ps yc ho me tr ic as se ss me nt of th e Sh or t fo rm

Im pr ov in g th e no rm al iz at io n of co mp le x in te rv en ti on s: me as ur e de ve lo pm en t ba se d on no rm al iz at io n pr oc es s th eo ry (N oM AD ): st ud y pr ot oc ol

Th e be ha vi ou r ch an ge wh ee l: a ne w me th od fo r ch ar ac te ri si ng an d de si gn in g be ha vi ou r ch an ge in te rv en ti on s , Im pl em en t. Sc i

Pe tt ic re w , De ve lo pi ng an d ev al ua ti ng co mp le x in te rv en ti on s: fo ll ov in g co ns id er ab le de ve lo pm en t in th e fi el d si nc e 20 06 , MR C an d NI HR ha ve jo in tl y co mm is si on ne d an up da te of th is gu id an ce to be pu bl is he d in 20 19 , Me d. Re s. Co un c ( 20 19 ) 1 -39 ht tp s: // mr c. uk ri . or g/ do cu me nt s/ pd f/ co