Ci a ion: Mena-Tudela, D.;
So iano-Vidal, F.J.; Vila-Candel, R.;
Quesada, J.A.; Aguila , L.;
F anco-An onio, C. E ec o
Mobile-Based Counselling on
B eas eeding in Spain: A
Randomized Con olled T ial
P o ocol (COMLACT S udy).
Heal hca e 2023,11, 1434. h ps://
doi.o g/10.3390/heal hca e11101434
Academic Edi o : Holge Muehlan
Recei ed: 10 Ma ch 2023
Re ised: 11 May 2023
Accep ed: 11 May 2023
Published: 15 May 2023
Copy igh : © 2023 by he au ho s.
Licensee MDPI, Basel, Swi ze land.
This a icle is an open access a icle
dis ibu ed unde he e ms and
condi ions o he C ea i e Commons
A ibu ion (CC BY) license (h ps://
c ea i ecommons.o g/licenses/by/
4.0/).
heal hca e
P o ocol
E ec o Mobile-Based Counselling on B eas eeding in Spain:
A Randomized Con olled T ial P o ocol (COMLACT S udy)
Desi ée Mena-Tudela 1, F ancisco Ja ie So iano-Vidal 2,3,* , Ra ael Vila-Candel 2,4,* ,
JoséAn onio Quesada 5,6 , Laia Aguila 7and C is ina F anco-An onio 8
1Depa men o Nu sing, Feminis Ins i u e Uni e si y Ins i u e o Feminis and Gende S udies,
Uni e si a Jaume I, 12071 Cas ellon de la Plana, Spain
2Depa men o Nu sing, Uni e si a de València, 46007 Valencia, Spain
3Depa men o Obs e ics and Gynecology, Xa i a-Oninyen Heal h Depa men , 46800 Xa i a, Spain
4Depa men o Obs e ics and Gynecology, Hospi al Uni e si a io de la Ribe a, 46600 Alzi a, Spain
5Depa men o Clinical Medicine, Uni e sidad Miguel He nández, 03202 Elche, Spain
6Ne wo k o Resea ch on Ch onici y, P ima y Ca e and Heal h P omo ion (RICAPPS), 03550 Alican e, Spain
7Midwi e y a Lac app Women Heal h, 08011 Ba celona, Spain
8Depa men o Nu sing, Uni e sidad de Ex emadu a, 10003 Cace es, Spain
*Co espondence: ancisco.j.so iano@u .es (F.J.S.-V.); a ael. ila@u .es o [email p o ec ed] (R.V.-C.)
Abs ac :
Pu pose: The p ima y aim o his s udy is o de e mine he in luence o an in e en ion in
women based on a ee mobile applica ion (Lac App
®
, Ba celona, Spain) in main aining b eas eeding
(BF) up o 6 mon hs pos pa um. The seconda y aim is o assess he e ec o heal h li e acy (HL)
on b eas eeding du a ion. Me hods: A mul icen e , andomized con olled clinical ial o pa allel
g oups will be ca ied ou . Women will be andomly assigned o each o he pa allel g oups. In
he con ol g oup, usual clinical p ac ice will be ollowed om he hi d imes e o p egnancy o
p omo e BF. In he in e en ion g oup, and in addi ion o usual clinical p ac ice, he women will use a
ee mobile applica ion (Lac App
®
) om he hi d imes e o 6 mon hs pos pa um. The ype o BF
a bi h, a 15 days and a 3 and 6 mon hs pos pa um and he causes o cessa ion o BF in bo h g oups
will be moni o ed. The hypo hesis will be es ed using in e en ial analysis, conside ing an alpha o
5%. The s udy p o ocol was app o ed by he Clinical Resea ch E hics Commi ee o Hospi al de la
Ribe a (Alzi a, Valencia, Spain) in Feb ua y 2021. A pe p o ocol analysis and an in en ion- o- ea
analysis will be pe o med. Discussion: This s udy will iden i y he in luence o a mobile applica ion
on imp o ing BF a es. I he applica ion p o es e ec i e, we will ha e a ool wi h ee in o ma ion
a ailable o any use a any ime o day, which may be complemen ed by no mal clinical p ac ice and
be in eg a ed in o ou heal h ca e sys em. T ial egis a ion: ClinicalT ials.go ID: NCT05432700.
Keywo ds:
exclusi e b eas eeding; b eas eeding; e-Heal h; mobile applica ion; midwi es; nu sing
1. In oduc ion
The Wo ld Heal h O ganiza ion (WHO) ecommends exclusi e b eas eeding (EBF)
o he i s six mon hs o an in an ’s li e, ollowed by complemen a y eeding un il he
in an is wo o mo e yea s old [
1
]. The WHO i mly suppo s his ype o eeding due o
he clea bene i s o b eas eeding (BF) o bo h he in an and he mo he [2–4].
In Spain, he EBF a es a 6 mon hs all well sho o he in e na ional ecommenda-
ions [5]. Di e en s udies ha e ound he BF a es o be abou 70% a ma e nal discha ge,
68.4% a 6 weeks o li e, and 24.7% a 6 mon hs pos pa um [
6
], hough o he mo e local
s udies epo e en lowe a es [
7
]. A ecen s udy on he p e alence o EBF up o 6 mon hs
o age ca ied ou in ou se ing [
8
], in ol ing a selec ed sample o women wi h an ea ly
s a o BF in 87.7% o he cases, documen ed an EBF a e o 38.6% a 6 mon hs pos pa um,
which is a below he wo ldwide a ge o 50% EBF a 6 mon hs es ablished by he WHO
o he yea 2025 [1].
Heal hca e 2023,11, 1434. h ps://doi.o g/10.3390/heal hca e11101434 h ps://www.mdpi.com/jou nal/heal hca e
Heal hca e 2023,11, 1434 2 o 12
A g ea a ie y o bene icial me hods o p omo ing BF ha e been e alua ed [
9
]. A
numbe o heal h in e en ions ha e shown imp o emen o he BF a es, wi h p oac i e
measu es and he ea lies in e en ion possible being he mos success ul s a egies [
10
].
Bo h indi idualized and pe sonalized suppo , as well as elephone media ed suppo i e
measu es, ha e demons a ed a o able ou comes [
11
,
12
], and he combina ion o a ious
o hese in e en ions enhances he e ec s and ou comes [13,14].
A p esen he e a e new in e en ions ha s ill need o be es ed o hei long- e m
e icacy, such as he use o mobile applica ions [
15
,
16
]. In his con ex , mobile heal h se ices,
mHeal h, a e de ined as medical and public heal h p ac ices compa ible wi h mobile de ices
such as sma phones, pa ien moni o ing de ices, pe sonal digi al assis an s and o he
wi eless de ices [
17
,
18
]. A la ge p opo ion o he Eu opean popula ion consul s online
in o ma ion o i s heal h p oblems [
19
]. These use s conside ha he in o ma ion hey
ind is going o be use ul o hem [
20
]. On he o he hand, heal hca e sys ems inc easingly
make use o online se ices in suppo o use s and heal hca e p o essionals, including he
u iliza ion o mobile applica ions [
21
]. Ne e heless, i mus be aken in o accoun ha he
use o such ools is no p opo ional wi hin he popula ion, and ha we mus ensu e ha
he in o ma ion p o ided is no only based on he bes a ailable scien i ic e idence, bu is
also accessible o women a isk o social exclusion [
22
]. In line wi h di e en s udies, he
applica ion o a p o ocolized in e en ion ha is accessible and adap ed o he needs o
women e ec i ely imp o es he a es and du a ion o BF [4,13,14,23–26].
On he o he hand, while he e is no single de ini ion o heal h li e acy (HL), he
e m e e s o use knowledge and skills in adequa e decision making in sociosani a y
ca e [
27
]. Such skills include eading, w i ing, making calcula ions, communica ion capaci y
and—inc easingly so— he use o in o ma ion echnologies. De icien HL has been ela ed
o poo heal h ou comes, including he ea ly suspension o BF [
28
–
30
], which is one o
he mos ele an public heal h p oblems and is o special impo ance in he ma e nal–
childhood popula ion.
In Spain, ew andomized clinical ials ha e analyzed he bene i s o in e en ions
based on mobile de ices in BF. The main objec i e o his s udy is o de e mine he in luence
o an in e en ion p og am in main aining BF up o 6 mon hs pos pa um. The seconda y
aim is o assess he HL le el o he pa icipan s and i s associa ion o he ea ly (less han
6 mon hs pos pa um) suspension o BF.
2. Ma e ials and Me hods
2.1. S udy Design
A mul icen e , andomized con olled ial (RCT) o pa allel g oups has been designed.
The clinical ial will be desc ibed acco ding o he Consolida ed S anda ds o Repo ing
T ials (CONSORT) [
31
] and using he Templa e o In e en ion Desc ip ion and Replica ion
checklis (TIDieR) [
32
]. The s udy has been egis e ed on ClinicalT ials.go Iden i ie :
NCT05432700.
2.2. Rec ui men
The s udy will be conduc ed in h ee public hospi als in eas e n Spain (Hospi al Lluis
Alcanyis, Hospi al Gene al de Cas ellón, and Hospi al Uni e si a io de la Ribe a), and
in one hospi al in he wes e n pa o he coun y (Hospi al San Ped o de Alcán a a de
Cáce es). The ou hospi als se e a o al popula ion o 500,000 inhabi an s, wi h an a e age
o 5000 bi hs a yea . The women will be included du ing he hi d imes e o p egnancy
in he di e en p ima y ca e midwi e consul ing ooms o each o he pa icipa ing cen e s.
The s udy exclusion c i e ia a e: emales unde 16 yea s o age; women wi h cogni i e
impai men s, language ba ie s, o illi e acy (no able o ead Spanish); non-a ailabili y o
a mobile de ice wi h in e ne connec ion; newbo n in an s wi h congeni al mal o ma ions;
win o mul iple p egnancies; and admission o he Neona al In ensi e Ca e Uni (NICU),
p ena al dea h o s illbi h, o pos pa um complica ions equi ing admission o he mo he
o he in ensi e ca e uni (ICU). Women ailing o espond o he au oma ed messages om
Heal hca e 2023,11, 1434 3 o 12
he pla o m a e h ee a emp s will also be excluded, in he same way as hose women in
he con ol g oup who ha e used he Lac App
®
applica ion on hei own ini ia i e. Figu e 1
shows he moni o ing o be ca ied ou du ing he s udy.
Heal hca e 2023, 11, x FOR PEER REVIEW 3 o 13
a mobile de ice wi h in e ne connec ion; newbo n in an s wi h congeni al mal o ma ions;
win o mul iple p egnancies; and admission o he Neona al In ensi e Ca e Uni (NICU),
p ena al dea h o s illbi h, o pos pa um complica ions equi ing admission o he
mo he o he in ensi e ca e uni (ICU). Women ailing o espond o he au oma ed mes-
sages om he pla o m a e h ee a emp s will also be excluded, in he same way as
hose women in he con ol g oup who ha e used he Lac App
®
applica ion on hei own
ini ia i e. Figu e 1 shows he moni o ing o be ca ied ou du ing he s udy.
Figu e 1. S udy design and in e en ions lowcha .
Figu e 1. S udy design and in e en ions lowcha .
Heal hca e 2023,11, 1434 4 o 12
2.3. Randomiza ion and Blinding
The women will be included du ing he hi d imes e o p egnancy in he di e en
p ima y ca e midwi e consul ing ooms o each o he pa icipa ing cen e s. A e eading
he in o ma ion shee and gi ing in o med consen , he women will be egis e ed on a
webpage c ea ed o he pu pose o he esea ch and will be assigned o one o he g oups
(con ol o in e en ion) ia a simple andomiza ion p ocess, un il he es ima ed sample
size has been eached. Randomiza ion will be pe o med using Epida .4.2. [
33
], wi h
g oups o equal size.
Alloca ion concealmen will be ca ied ou , wi h blinding o he midwi es in cha ge o
ec ui ing he women, p o iding hem wi h sealed, opaque and sequen ially numbe ed
en elopes o be deli e ed o each new pa icipan wishing he pa icipa e in he s udy.
The esea ch eam will p epa e he en elopes based on he andom alloca ion sequence.
Each en elope will con ain a ca d wi h a QR code p o iding access o he s udy ollow-up
pla o m. Follow-up da a collec ion will be conduc ed by ano he esea che blinded o
he g oup s a us o pa icipan s. Only he da a manage will ha e access o all o he
in eg a ed da a ( he da a epo ed by he pa icipa ing women h ough he su eys and he
bi h/pos pa um da a epo ed by he p incipal in es iga o s).
2.4. Sample Size De e mina ion
Based on p e ious s udies [
15
], and assuming he BF suspension a e a 6 mon hs o
be 60% in he con ol g oup e sus 40% in he in e en ion g oup, wi h a signi icance le el
o p< 0.05 and a s a is ical powe o 85%, a balanced design would equi e 333 women in
o al. Compensa ing o an es ima ed loss a e o 20%, he es ima ed inal o al sample size
would be 399 women.
2.5. In e en ion
2.5.1. Bo h G oups
The s udy sample will be compiled du ing he hi d imes e o p egnancy in he
di e en p ima y ca e midwi e consul ing ooms o each o he pa icipa ing cen e s. A e
ecei ing he en elope, he women will ead he QR code wi h hei mobile de ice and will
be egis e ed in he nu sing pla o m c ea ed o he s udy, a e accep ing he p i acy policy
s a emen . Bo h he in e en ion g oup and he con ol g oup will unde go an ini ial su ey
o eco d sociodemog aphic da a, p e ious expe ience wi h BF, and he p obable da e o
deli e y. In addi ion, wo sel -adminis e ed ques ionnai es will be comple ed—one on HL
(HLS-EU-Q16) [
34
] and ano he on heal h- ela ed quali y o li e (EQ-5D-5L) [
35
]— h ough
he e-mail accoun egis e ed on he pla o m.
Planning o eminde s ia e-mail will be pe o med o ob ain in o ma ion e e ed o
ollow-up, a all imes a oiding he p o ision o any ex a in o ma ion on BF. Du ing p eg-
nancy, based on he p egnancy p o ocol and usual clinical p ac ice, pa en ole educa ion
and nu sing wo kshops will be planned o bo h g oups, wi h he a ailabili y o di e en
manuals o be gi en o each p egnan woman [36].
The pla o m will send se ial e-mails o bo h s udy a ms (in e en ion and con ol) o
ollow-up on he ype o nu sing a e bi h, a 15 days, a 6 weeks, and a 3 and 6 mon hs.
Ques ions will be asked ega ding he ype o nu sing and BF- ela ed p oblems, and he
b eas eeding sel -e icacy scale—sho o m (BSES-SF) will be applied [
37
]. In he e en
o he suspension o BF, he eason o suspension will be eco ded, along wi h he o al
b eas eeding ime. A 3 and 6 mon hs pos pa um, new measu emen s will be made wi h
he heal h- ela ed quali y o li e ques ionnai e (EQ-5D).
2.5.2. Con ol G oup (Usual Ca e)
Usual ca e includes indi idual counseling on he bene i s o main aining BF du ing
he i s 6 mon hs and on he in oduc ion o supplemen a y oods. The mo he should
be seen a leas 6 imes by he midwi e and p ima y ca e pedia ician be o e he in an is
6 mon hs old.
Heal hca e 2023,11, 1434 5 o 12
2.5.3. In e en ion G oup (Mobile Applica ion G oup)
F om he i s eco ding du ing he i s imes e , he women will be able o consul all
he a ailable in o ma ion in he applica ion. Lac App
®
is a ee access mobile applica ion
de eloped h ough Apple S o e and Google Play, and can be consul ed in English and
Spanish [
38
,
39
]. The cen al unc ion o Lac App
®
is i s au oma ed nu sing consul a ion
s uc u e. This ool also uses a i icial in elligence and is a ailable 24 h a day wi h a
connec ion o he In e ne , p o iding con enien and pe sonalized suppo . Lac App
®
includes a sel -managemen o m based on o e 50 decision ees wi h ques ions and
answe s de eloped by nu sing expe s, and is suppo ed by scien i ic e idence and cu en
o icial heal h ecommenda ions. The ques ionnai e gene a es o e 2300 pe sonalized
eplies ha can be eached h ough o e 76,100 po en ial ou es ha a y i ing o he
p o ile o he use s and he op ions selec ed by he la e . In addi ion, he applica ion
eminds he use abou he ollowing issues, depending on he en e ed da e o bi h:
•
The i s ou weeks: posi ioning o he in an o b eas eeding, equency o milk
in ake, numbe and consis ency o s ools, gene al ca e o he b eas , and weigh gain
o he newbo n. Fo women p o iding ood supplemen s, he ool o e s counseling
and suppo o e u ning o b eas eeding.
•
F om mon hs wo o h ee: ecommenda ions on milk ex ac ion o c ea e a ese e
in case o ha ing o e u n o wo k o lea e home, wi h ins uc ions on handling and
s o age o he collec ed milk.
•
F om mon hs ou o six: how o use he milk ese e (i any) and echniques o
adminis e ing he s o ed milk, placing emphasis on he impo ance o suppo ing BF
and he ad isabili y o no using o he ypes o eeding.
I he in e en ion is e ec i e and di e ences a e ound be ween he wo g oups, an
analysis will be conduc ed wi hin he in e en ion g oup o analyze he p o ile o women
who a e less likely o abandon BF a 6 mon hs based on baseline a iables, by adjus ing a
mul iple logis ic eg ession model, es ima ing he co esponding ORs and 95%CIs.
2.6. Da a Collec ion and Follow-Up
The collec ed da a will be en e ed in o an elec onic o m, gua an eeing con iden iali y
and anonymi y, and ensu ing compliance wi h he applicable egula ions. Likewise, losses
and d opou s du ing he ial will be de ailed, along wi h he co esponding causes. In
addi ion, e-mails will be sen o he mo he s, in i ing hem o ollow-up on b eas eeding
using he sel -adminis e ed ques ionnai e ound on he c ea ed web pla o m.
The p incipal in es iga o s will ha e access o he body o il e ed da a on he websi e
c ea ed o he p ojec , p o ec ed by a passwo d, o be able o e ospec i ely en e he bi h
da a and he numbe o pos pa um isi s o he di e en heal h p o essionals. In o de o
gua an ee con iden iali y, he da a supplied o he p ojec eam membe s will no con ain
in o ma ion capable o iden i ying he pa icipan s.
2.7. Baseline Va iables
The ollowing a iables will be collec ed a baseline:
- Sociodemog aphic a iables: ma e nal age a he p obable da e o deli e y, coun-
y o o igin (Spain/ o eign), le el o educa ion (p ima y school o lowe /seconda y
school/uni e si y), employmen s a us (sel -employmen /p o essional/manage ial em-
ploymen /employee/unemployed/s uden /no looking o a job), ci il s a us (single/
ma ied/sepa a ed-di o ced), pa ne (yes/no), numbe o li e o sp ing, p e ious expe-
ience wi h b eas eeding (yes/no), pa icipa ion in ma e nal educa ion g oups (yes/no),
ecep ion o p e ious in o ma ion on BF (yes/no), and pa icipa ion in BF suppo g oups
(yes/no).
- Va iables ela ed o heal h li e acy: as a sc eening ool, use will be made o he
HLS-EU-Q16, which e alua es he HL o he popula ion based on 16 i ems sco ed by means
o a Like scale om “ e y easy” o “ e y di icul ”. This is a uni ac o ial scale wi h
Heal hca e 2023,11, 1434 6 o 12
good in e nal consis ency as measu ed by McDonald’s omega, wi h a alue o 0.982 in he
Spanish popula ion [34].
- Va iables e e ed o heal h- ela ed quali y o li e: use will be made o he EQ-
5D [
40
] in he baseline measu emen s and a 3 and 6 mon hs. This scale is e y sensi i e
o quali y o li e measu es and has been shown o be e en mo e sensi i e in women [
41
].
I comp ises 5 i ems ela ed o mobili y, pe sonal ca e, daily ac i i ies, pain/discom o ,
and anxie y/dep ession. I uses a isual analogue scale (VAS) om 0 o 100 o measu ing
heal h condi ion a he ime o applica ion o he ques ionnai e [42].
- Va iables ela ed o sel -e icacy o BF: he measu emen o sel -e icacy will be made
wi h he BSES-SF scale in i s Spanish e sion [
37
]. This ins umen consis s o 14 i ems
sco ed by means o a Like scale om 1 (no a all) o 5 (always). The BSES-SF is a
unidimensional scale wi h a C onbach alpha o 0.79 in i s Spanish e sion.
- Obs e ic-neona al a iables. The ollowing in o ma ion will be collec ed e ospec-
i ely om he elec onic case his o y: ges a ional age (days) a he ime o bi h, pa i y
(none/one o mo e), ype o p e ious deli e ies (none/eu ocic/o he ), onse o labo (spon-
aneous/induced/s imula ed), up u e (spon aneous/a i icial), g oup B s ep ococcus
(posi i e/nega i e), in apa um an ibio ic use (yes/no), in apa um analgesia (inhala-
o y/local/epidu al/none), K is elle maneu e (yes/no), comple ion o deli e y (eu ocic
aginal/eu ocic ins umen al ( acuum, spa ulas, o ceps), in apa um cesa ean sec ion),
episio omy (yes/no), pe ineal condi ion ollowing bi h (in ac /g ade 1/g ade 2/g ade
3/g ade 4), newbo n gende ( emale/male), newbo n weigh (g ams), Apga sco e, umbil-
ical a e ial pH a bi h, ea ly skin- o-skin con ac (wi hin 30 min and las ing o a leas
2 con inuous hou s) (yes/no/wi h a he ), ea ly s a o b eas eeding (wi hin 2 h/a e
mo e han 2 h), d inking allowed du ing deli e y (yes/no), accompanimen o ma e nal
choice allowed (yes/no), mobiliza ion allowed du ing deli e y (yes/no), and posi ioning
in momen o bi h ( e ical/lying down—li ho omy posi ion/la e al decubi us).
- Response a iable: ype o nu sing (BF/SF/MF) a 6 mon hs pos pa um, o as-
sess newbo n and in an eeding p ac ices, wi h he ollowing op ions: (a) BF, including
ex ac ed o dono milk. The in an only ecei es d ops o sy ups ( i amins, mine al,
medicines); (b) SF (supplemen a y eeding), whe e in an eeding is limi ed o a i icial
o mulas and solid; and (c) MF (mixed eeding), whe e in an eeding combines BF and
SF. All women in end o o e BF a e bi h. The esponse a iable “Suspension o BF a
6 mon hs” (yes/no) will be conside ed, whe e “yes” means he in an is ecei ing SF and
“no” means he in an con inues wi h BF o MF a 6 mon hs.
- Va iables ela ed o suspension o BF: ype o suspension ( o al o pa ial), cause o
ea ly suspension (be o e 6 mon hs pos pa um), and o al du a ion o BF in ull days om
ime o bi h.
- Follow-up a iables: pa icipa ion in suppo g oups, and numbe o midwi e/
pedia ician/pedia ic nu se isi s du ing he i s 6 mon hs. E en i women suspend BF,
he numbe o isi s o hese heal h p o essionals will con inue o be coun ed o up o
6 mon hs.
- Va iables ela ed o BF educa ion ecei ed o 6 mon hs: in o ma ion/ aining in
BF (none/p e ious in o ma ion ecei ed om ela i es, iends o heal h p o essionals
(midwi e, pedia ic nu se, obs e ician, pedia ician)), consul a ion o ex s, pa icipa ion
in bi h p epa a ion g oups, nu sing g oups o pos pa um g oups, and he use o digi al
ools (yes/no/speci y which).
- Lac App
®
use will be assessed om women’s epo s on he accep abili y and
con enience o he mobile applica ion while du ing use. Da a will be collec ed on he
numbe o connec ions made, ime o use, and opics consul ed. All o hese da a will be
p o ided by he company in an anonymized o m. No p i a e in o ma ion esul ing om
he mobile applica ion will be collec ed.
Heal hca e 2023,11, 1434 7 o 12
2.8. Da a Analysis
An analysis will be pe o med o he baseline cha ac e is ics be ween he g oup o
possible losses o ollow-up and he g oup o women ha comple e ollow-up, based on
wo-inpu ables and he compa ison o means, using he Fishe exac es o Mann–Whi ney
U- es , as applicable.
Tes ing o he homogenei y o g oups will be comple ed ega ding he baseline a i-
ables and bi h- ela ed pa ame e s and he suspension o BF a 6 mon hs, using wo-inpu
ables and he chi-squa e es (
χ2
) o Fishe exac es , as applicable, while he compa ison
o means will be pe o med using he Mann–Whi ney U- es .
A pe -p o ocol (PP) analysis and in en ion- o- ea (ITT) analysis will be ca ied ou . In
he PP analysis, con inuous a iables will be epo ed as he mean and s anda d de ia ion
(SD), o as he median and in e qua ile ange (IQR) in he case o a non-no mal da a
dis ibu ion, while ca ego ical a iables will be epo ed as equencies and pe cen ages.
Da a no mali y will be assessed using he Kolmogo o –Smi no es .
In he ITT analysis, sensi i i y e e ing o losses du ing ollow-up will be assessed,
wi h he esponse a iable o he in e en ion g oup being assigned he wo s esul possible
(suspension o BF a 6 mon hs) and he con ol g oup being assigned he bes esul possible
(no suspension o BF). E alua ion o he di e ences in esponse a iable be ween he wo
g oups will be pe o med, wi h all andomized subjec s, applying he chi-squa e es .
2.8.1. P ima y Ou come
The e icacy o he in e en ion in ela ion o he suspension o BF a 6 mon hs will
be assessed om wo-inpu ables wi h applica ion o he chi-squa e es (
χ2
). Likewise,
mul i a ia e logis ic eg ession analysis will be used, wi h calcula ion o he odds a io
(OR) co esponding o he suspension o BF a 6 mon hs, and he 95% con idence in e al
(95%CI).
2.8.2. Seconda y Ou come
The le el o HL (adequa e s. inadequa e) wi h he HLS-EU-Q16 sc eening ool and
he cha ac e is ics o he women who ga e up BF a 6 mon hs (yes/no) will be assessed ia
wo-inpu ables wi h applica ion o he chi-squa e es (
χ2
) o quali a i e a iables. Mul i-
a ia e logis ic models will be used in o de o analyze he magni ude o he associa ion
wi h BF a 6 mon hs. The adjus ed odds a io (OR) and 95% con idence in e al (95%CI)
will be calcula ed, and p- alues will be p esen ed.
Da a analysis will be pe o med using SPSS .26.0 o Windows (IBM Co p. 2018,
A monk, NY, USA) and R (R p ojec 2019, e sion 4.0.2). The le el o s a is ical signi icance
de ined was p< 0.005.
2.9. E hical Conside a ions
The p o ocol is egis e ed in ClinicalT ials.go ID: NCT05432700. The s udy will abide
by O ganic Ac 3/2018, o 5 Decembe , e e ing o pe sonal da a p o ec ion and he gua an-
ee o digi al igh s, and by Ac 41/2002, o 14 No embe , egula ing pa ien au onomy and
he igh s and obliga ions in ela ion o in o ma ion and scien i ic documen a ion. Likewise,
he e hical p inciples o he Decla a ion o Helsinki will be ollowed. In o med consen
will be ob ained om all he pa icipa ing women. Lac App
®
complies wi h he policies
e e ing o p i acy and cookies, gua an eeing abidance wi h he measu es equi ed by Reg-
ula ion (EU) 2016/679 o he Eu opean Pa liamen and Council, o 27 Ap il 2016, ega ding
he p o ec ion o physical pe sons wi h ega d o o pe sonal da a and he ee ci cula ion
o such da a, O ganic Ac 15/1999, o 13 Decembe wi h ega d o da a p o ec ion (LOPD),
and Spanish Royal Dec ee 1720/2007, o 21 Decembe , wi h due decla a ion be o e he
Spanish Da a P o ec ion Agency. Likewise, he s udy will abide by Ac 34/2002, o 11 July,
on elec onic comme ce and in o ma ion ega ding he use o cookies (LSSICE), exp essly
equi ing consen om he use s egis e ed o he applica ion.
Heal hca e 2023,11, 1434 8 o 12
2.10. Validi y and Reliabili y
The en i e da ase will be con i med a e collec ion, and any subjec s ound will be
di ec ly amended by he esea che . The iden i ica ion o ob ious e o s and ou lie s in he
da a will be shown by desc ip i e analysis. When necessa y, da a will be double-checked
agains he o iginal da abases.
Fac o s such as age, educa ion le el, employmen si ua ion, and p e ious expe ience
wi h BF may in luence he esul s o he s udy. Due o andomiza ion, decompensa ed key
a iables be ween g oups a e no expec ed. Howe e , i poo ly dis ibu ed cha ac e is ics
a e ound, hese a iables will be included as independen a iables along wi h he exposu e
a iables in he mul i a ia e analysis models.
3. Discussion
The pu pose o his ial is o explo e he impac o an in e en ion p og am based
on he use o a mobile applica ion in main aining b eas eeding up o 6 mon hs pos pa -
um. The null hypo hesis is ha he Lac App
®
mobile applica ion does no imp o e he
main enance o BF a 6 mon hs pos pa um e sus usual clinical p ac ice.
B eas eeding is no only a physiological p ocess bu also en ails cul u al lea ning,
causing mo he s o ac i ely seek in o ma ion [
19
]. Nowadays, online communica ion
op ions ha e been inco po a ed in o his ac i e sea ch o in o ma ion [
24
], and he adop-
ion o such new echnologies has been associa ed wi h imp o ed nu sing a es [
43
,
44
].
Al hough no unde p o essional in luence, he use o in o ma ion and communica ion
echnologies in daily li e mus be acknowledged, and such ools should be used as a means
o dissemina e quali y in o ma ion based on e idence [
45
]. In 2018, 67.3% o he Spanish
popula ion used he In e ne o ob ain in o ma ion on heal h, and in his ega d, mobile
applica ions cons i u e a g owing con ibu ion in he ield o in o ma ion and communica-
ion echnology [
45
]. Heal h p o essionals mus make e o s o consolida e hei posi ion
as a e e ence in hese new se ings as well. I hey p o e e ec i e and accep able o he
popula ion o which hey a e in ended, ins umen s o his kind could be in oduced as
in e en ion ools o p omo ing and main aining BF.
An impo an pe cen age o use s inc easingly ake an ac i e ole in issues ela ed o
heal h and illness and hei ela ion o he sociosani a y sys em [
46
], lea ing behind he
passi e o me e spec a o oles o he pas [
47
]. In his con ex , i is a ac ha p egnan
women commen o hei midwi e wha hey ha e ead on he In e ne , and wish o discuss
such in o ma ion [
45
]. A p esen , h ee ou o e e y ou use s consul he In e ne wi h
ega d o heal h issues. This p ocess o empowe men de ines he “expe pa ien ”, who
seeks in o ma ion bo h be o e and a e isi ing a heal hca e p o essional [
48
]. Thus, i
mus be accep ed ha in con empo a y ma e ni y ca e, women ou inely and massi ely
use online sou ces o ob ain in o ma ion abou hei p egnancy, and consequen ly he
ma e nal–in an heal h se ices should adop s a egies ha ake his phenomenon in o
accoun [
49
]. Such conside a ion also applies o b eas eeding, whe e he endencies a e
changing, and women now seek online in o ma ion abou in an eeding jus as o en as
hey end o consul nea by amily and iends [
50
], ecei ing bo h online suppo and
in o ma ion h ough social ne wo ks, ideo calls, o mobile applica ions [
51
]. A ecen
sys ema ic e iew and me a-analysis [
15
] o 15 andomized con olled ials (RCTs) o
mHeal h in e en ions o BF ound ha hese in e en ions signi ican ly inc eased EBF
a es a 1, 2, 3, and 6 mon hs pos pa um and imp o ed BF sel -e icacy, bu no a i udes.
Upda ed applica ions a e needed in he la es ecommenda ions on nu sing [
49
,
52
], wi h
ex e nal e alua ion gua an ees.
Thus, he adi ional ca e model mus in eg a e elec onic de ices and in o ma ion and
communica ion echnologies o ensu e imp o ed pe o mance, since eliance upon heal h-
ca e p o essionals could dec ease, gi ing way o he a ailabili y o in e ac i e in o ma ion
h ough he di e en echnological pla o ms [
15
,
53
]. Heal h- ela ed applica ions, mobile
phones, blogs, and speci ic websi es a e ypically used by women o childbea ing age and
may help imp o e he expe ience o p egnancy and mo he hood. I is essen ial o bo h
Heal hca e 2023,11, 1434 9 o 12
p o essionals and heal h supe iso s o be awa e o hese new de elopmen s, which can
in luence he heal h o women, and o an icipa e he imminen change in ca e model [
54
,
55
].
4. Limi a ions
The p esen s udy has i s limi a ions. The le el o adhe ence o decisions o he
p egnan women when he issue o b eas eeding is aised du ing he moni o ing o
p egnancy may depend on a numbe o ac o s such as he ype o in o ma ion gi en
o he women and he way in which he heal h p o essionals communica e wi h hem.
In e ec , we conside ha a o able heal h ou comes o be la gely dependen upon he
complex in e ac ion be ween he heal h p o essional and he pa ien o use . Howe e , he
aim o ou s udy is o explo e he pa ien - ela ed ac o s ha acili a e o complica e BF,
such as poo heal h li e acy, wi h e e ence o he body o li e a u e ci ed in he p o ocol.
Since he e is cu en ly no s anda dized and p o ocolized mechanism o de e mining
he skills o p egnan women in making e ec i e use o he in o ma ion p o ided, we
conside i p uden o assume ha he in o ma ion supplied will be mo e o less he same
o each woman (Lac App
®
+ p o essional), and ha women wi h limi ed HL will be mo e
p one o making subop imal decisions as a esul . In iew o hese sho comings, we
eel ha i will be di icul o ind compensa ion mechanisms o hese women. Logically,
his does no ob ia e he indi idual e o s which he p o essionals may make o sol e
p oblems such as poo unde s anding o language issues. None heless, we belie e ha
he added complexi y o ying o sys ema ize and de ine such e o s alls beyond he
scope o ou s udy. Fu he mo e, a con amina ion e ec could occu among he women
pa icipa ing in he s udy, ela ing o he exchange o in o ma ion ega ding he use o
he mobile applica ion. This could be de ec ed h ough he pe iodic elec onic nu sing
ollow-up su eys, e alua ing whe he he women in he con ol g oup make use o online
ools. Such use would be eason o exclusion om his s udy. Ano he limi a ion may
be he numbe o losses o e ollow-up. The sel -comple ed elec onic su ey ia he
In e ne has many ad an ages such as speed o da a collec ion, lowe cos , and can p o ide
an a ac i e design o he esponden [
41
]. The downside is ha he e may be a lowe
esponse a e, which may a ec he esul s ob ained. In o de o con ol o such selec ion
bias and b eak o andomiza ion, an analysis will be pe o med o he cha ac e is ics o he
g oup o d opou s, along wi h an in en ion- o- ea analysis.
Finally, i should be no ed ha he e a e limi a ions ela ed o he cha ac e is ics o
he sample. The esul s canno be ex apola ed o speci ic popula ions such as mul iple
p egnancies, newbo ns admi ed o he neona al in ensi e ca e uni , o women who ex-
pe ience complica ions in he pos pa um pe iod because o he di icul y o ini ia ing
b eas eeding. On he o he hand, ou sociocul u al con ex and common access o mobile
de ices in ou en i onmen will limi he ex apola ion o esul s o o he popula ions wi h
ma ked di e ences.
5. Conclusions
A e conduc ing his ial, i will be possible o e alua e he b eas eeding a e
6 mon hs pos pa um among women who ha e used he mobile applica ion.
I he sea ch o in o ma ion on heal h- ela ed opics inc eases hei consul a ions, we
should a leas conside ha use s need o expand o con as he in o ma ion ecei ed. I is
impo an ha we become in ol ed in he c ea ion o digi al con en so ha he in o ma ion
ecei ed by use s is u h ul, complemen a y and e i ied. I he applica ion p o es o
be e ec i e, we will ha e a ool wi h in o ma ion ee o cha ge, a ailable o any use , a
any ime o he day, which can be complemen a y o no mal clinical p ac ice and can be
in eg a ed in o ou heal hca e sys em. Fo all o hese easons, he p ojec demons a es i s
ansla ional alue, since he basis o he in e en ion is a ee and openly accessible mobile
applica ion ha could also be used in o he a eas.
