Effectiveness of a Home-based Peer Support Program for Chinese Mothers With Low Breastfeeding Self-efficacy to Increase the Exclusivity and Duration of Breastfeeding: a Randomized Controlled Trial
Phase: NA
Conditions: Breastfeeding
Sponsor: The University of Hong Kong

 
 
 
 
 
 
 
 
 
Cover page 
 
Title: Effectiveness of a home-based peer support program for Chinese mothers with low 
breastfeeding self-efficacy to increase the exclusivity and duration of breastfeeding: a 
randomized controlled trial. 
 
NCT number: NCT04621266 
 
Document date: 6th April 2020 
 
Document: Study Protocol  

Study Protocol 
 
Title: Effectiveness of a home-based peer support program for Chinese mothers with low 
breastfeeding self-efficacy to increase the exclusivity and duration of breastfeeding: a 
randomized controlled trial.  
Background Information 
 
The World Health Organization’s (WHO) Global Strategy for Infant and Young Child Feeding, which 
aims to improve rates for breastfeeding recommends that national governments develop a network of 
community-based mother-to-mother breastfeeding support groups and ‘lay and peer counsellors’ to 
enhance existing service [1]. Professional health workers can help improve breastfeeding practices. In 
resource limited-settings, lack of health workers hinders effective breastfeeding and emotional support. 
Therefore, we have to depend on peer support to provide knowledge, experience, emotional or practical 
help. When mothers participate in groups of social activities or receive one-on-one counseling from 
another mother in the community, they can communicate with each other and exchange knowledge 
among themselves. Such one on one or group peer support for mothers allow them to support each 
other, helps in decision making and subsequently empower them [2]. Thus, these interventions have 
potential to improve breastfeeding practices and child wellbeing [3]. Such interventions have therefore 
been considered as sustainable alternative to counseling in primary health care settings [4]. These are 
potentially lower cost interventions compared to those provided by professional health care workers [5]. 
Recently updated Cochrane review based on 52 RCTs including 37 high income countries indicate that 
extra support was likely to be more effective in settings with high initiation rates, when delivered face-to-
face when offered proactively and on an on-going scheduled basis and tailored to the needs of the 
population [6]. 
 
Peer counselling is being introduced worldwide in supporting mothers’ needs for successful maintenance 
of breastfeeding. Findings from a Cochrane review suggest that postnatal care at home may reduce infant 
health service utilization in the weeks following the birth, and that more home visits may encourage 
more women to exclusively breastfeed [7]. In high resource settings healthy women and babies are 
frequently discharged from hospital within one or two days of birth, potentially home visits in the first 
few days of the birth by healthcare professions or trained support workers offer opportunities for 
assessment of the mother and new born, health education, infant feeding support, emotional and 
practical support.[8-11] By having existing trained peer counsellors (PC) by La Leche League (HK) from 
our previous project, we propose to conduct a (web-based) home-based peer support programme for 
mothers who intend to breastfeed but have a low self-efficacy in breastfeeding. We understand mothers 
are often housebound and find it difficult to attend group support or seek help during the first month 
postpartum which is the critical period in sustaining exclusive breastfeeding and are at high risk in 
developing postpartum depression. Peer supporters help women overcome their breastfeeding problems, 
and women report improved mental health through increased self-esteem, confidence and well-being 
[12]. 
 
In Hong Kong around 20% of women are affected by mental illness either during pregnancy or in the 12 
months after giving birth. These include anxiety, depression and postpartum psychosis. Any of these can 
have a profound effect on breastfeeding and it is important that families can access support at this 
critical time. There is evidence that breastfeeding can have a preventive effect on mental illness 
developing. Mothers who plan, but unable to breastfeed their babies are more likely to suffer from 
postnatal depression. A large scale research study in the UK showed that mothers who planned to 
breastfeed and who actually went on to breastfeed were around 50% less likely to become depressed that 
mothers who had not planned to, and who did not, breastfeed. Mothers who planned to breastfeed but 
who did not go to breastfeed were over twice as likely to become depressed as mothers who had not 
planned to, and who did not breastfeed [13]. Due to the nature of the study’s design, it cannot prove that 
not breastfeeding raises the risk of postnatal depression. However, it highlights the need to support new 
mothers who want to breastfeed but are unable to do so. Around 20% of women develop postnatal 
depression during pregnancy or in the 12 months after giving birth which has long-term sequelae on the 
family and the infant’s psychosocial development.  
 
A Cochrane Review of support for breastfeeding mothers aimed at what kind of support can be provided 
to help mothers solve any problem concluded that trained volunteers and doctors and nurses had a 
positive impact on breastfeeding. Factors that may have contributed to the success for women who 

exclusively breastfed were face-to-face contact, volunteer support, and specific schedule of four to eight 
contacts are more likely to succeed with women practicing exclusive breastfeeding [14]. A systematic 
review indicated that community based peer support for mothers is effective in increasing the duration 
of exclusive breastfeeding, moreover mothers are more likely to exclusively breastfeed when they receive 
peer support one on one or through a mother’s group [15]. Therefore a feasibility randomized controlled 
trial (RCT) of home-based breastfeeding peer support programme was conducted by our team to 
determine if a future definitive RCT could be conducted to improve breastfeeding outcomes among new 
mothers who intend to breastfeed but have low self-efficacy on breastfeeding. Participants were recruited 
on a postnatal ward, eighty-five mothers were approached and 20 were screened eligible and randomly 
allocated into the two arms (with peer support intervention versus usual care). A higher percentage of 
mothers’ exclusively breastfed at 1 month (44% versus 33%), 2 months (43% vs 25%) and 4 months 
postpartum (50% vs 33%) in the peer support arm compared to usual care. Views on the program from 
qualitative interviews from the participants after the intervention were positive and met their 
expectation. The advantages of the intervention stated by all participants were they have a point of 
contact in which they have someone to speak to directly about their problems. Volunteer’s response is 
quicker and the process is faster compared with ‘usual maternity care’. Peer support provided more 
emotional support and care which relieves pressure for first-time mothers. Participants feel more 
comfortable to speak with the volunteers compared to health professionals as they found nurses in 
hospital and clinics were too routine and more concerned with scientific or quantitative issues. These 
findings from the feasibility study demonstrate that women value peer supporters as mothers with 
similar experiences who can relate to their own situation through a shared language. Therefore, a home-
based peer support intervention is recommended for the proposed study. 
 
Summary of known and potential risks and benefits 
As intervention involves peer support (face-to-face) and no invasive procedures will be involved, risks to 
women and their infants are likely to be minimal. In terms of confidentiality and anonymity, analysis will 
take place on anonymous data. Personal identifiable data will be held separately from the anonymous 
data used for analysis.   
 
Benefits include women gaining in awareness of the value of breastfeeding for their own and for their 
infant’s health, and feeling supported in this aspect of caring for their infants.  
 
1 Objectives and Purpose 
The aim of the proposed study is to evaluate the effectiveness of a (web-based) home-based 
breastfeeding peer support program in improving breastfeeding practices among women with low 
breastfeeding self-efficacy. 
2 Design 
This is a two armed blinded randomized controlled trial. 442 women will be recruited from four 
hospitals. Trained peer counsellors will provide home based (web based due to 5th Covid wave) one-to-
one breastfeeding intervention sessions to the participants.  
 
Study Procedure 
1. 
Recruitment: 
Mother-infant pairs will be recruited from a hospital that has an average of 300+ deliveries per 
month. Eligible participants will be approached and invited to join the study in antenatal clinics. 
Women who agree to participate and sign the consent form will be invited to complete the following 
forms available both in Chinese or English version: 
a. Demographic Data Collection Form  
b. Breastfeeding Self-efficacy and Attitude Data Collection Form 
 
Research assistant will complete the following form from participants’ medical records: 
a. Maternal and Birth Data Collection Form 
 
 
This study includes two study arms: 
a. Home-based peer support programme (web-based) and standard usual care  
b. Control group will be standard usual care  

 
Participants will be randomized following completion of the baseline data. Block randomization 
procedures with random block sizes of 2, 4 or 6 will be used. An independent research assistant who 
will not participate in participant recruitment, data collection and analysis will generate the 
allocation sequence using the statistical software Stata 14. Allocation sequences will be kept in 
sequential numbered, opaque, sealed envelopes. Outcome assessors will be blinded to the treatment 
allocation. The research assistant will draw the first sealed envelope from the box and participants 
will be allocated to that intervention group.  
 
2. Telephone follow-up call: 
The participants will receive follow-up telephone calls at one, two, four and 6 months postpartum. 
Each follow-up call will take approximately 15 minutes. 
 
The following forms will be completed by a research assistant in the telephone follow-ups: 
 
One month follow-up:  
a.   One-Month Follow-up Data Collection Form 
 
Two months follow-up: 
a. Two-Month Follow-up Telephone Data Collection Form 
b. Breastfeeding Self-efficacy and Attitude Data Collection Form 
 
Four months follow-up: 
a. Four-Month Follow-up Telephone Data Collection Form 
b. Breastfeeding Self-efficacy and Attitude Data Collection Form 
 
Six month follow-up: 
a. Six-Month Follow-up Telephone Data Collection Form 
 
These data collection forms will be completed if needed: 
b. Weaning Data Collection Form (if participants’ babies have been weaned) 
c. Return to Work Data Collection Form (if participants have return to work) 
 
 
Data Sources 
Data collection will consist of: (1) baseline demographic data will include data such as education, 
income, employment, family composition, antenatal education, (2) maternal and infant data which will 
include data on the mother’s previous obstetrical history, delivery data and basic infant health data. 
 
Study Outcome 
Primary outcome: Infant feeding status. 
  
Key Measures 
• 
Infant Feeding Status:  Patterns of breast milk feeding as assessed at each follow up point 
will be classified according to existing World Health Organization definitions. Infants will be 
considered exclusively breastfed if they receive no solids, no non-breast milk, or no water or 
other liquids (other than vitamins or medications). Non-exclusively breastfed infants 
supplemented with infant-formula or other milk substitutes can, if required, be further classified 
as high partial breastfeeding (>80% of feeds are breast milk), medium-partial breastfeeding (20 
to 80% of feeds are breast milk), low partial breastfeeding (<20% of feeds are breast milk). 
Infant feeding patterns will also be categorized according to definitions that include both the 
type and mode of infant feeding: (1) direct breastfeeding only, (2) expressed breast milk only, (3) 
direct breastfeeding and expressed breast milk feeding, (4) direct breastfeeding and formula 
feeding, (5) expressed breast milk feeding and formula feeding, (6) direct breastfeeding, 
expressed breast milk feeding, and formula feeding, and (7) formula feeding only. We will 
compare the overall duration of any and exclusive breastfeeding among participants in the (web-
based) home-based peer support programme to the control group which received standard post-
natal care only. 

• 
Breastfeeding Self-efficacy:  Maternal breastfeeding self-efficacy will be measured using the 
Breastfeeding Self-Efficacy Scale Short-Form (BSES-SF) (Chinese and English version). The 
BSES-SF consists of 14 items measured on a 5-point Likert scale that begin with the phrase “I 
can always.” On the scale 1 indicates “not at all confident” and 5 indicates “always confident. 
Total scale scores range from 14 to 70 with higher scores indicting greater breastfeeding 
confidence and self-efficacy. We will administer the BSES-SF in baseline period and at 2 and 4 
months postpartum. We will compare the scores among intervention and control groups. 
Permission to use the BSES-SF has been granted by the authors of both the original and Hong 
Kong Chinese versions.  
• 
Edinburgh Postnatal Depression scale: Participant’s postpartum depression symptoms 
will be measured by EPDS, Chinese version. It is an instrument consisting of 10 simple and 
easily understood items, with rating on a scale from 0 to 3, yielding a total range of 0 to 30. 
EPDS was developed by Cox et al (1987) and has been widely used for the assessment of 
postnatal depressive symptoms, but it is not a diagnostic scale for depression, rather a screening 
tool for those vulnerable to developing depression. The Chinese version of EPDS has been 
validated and shown to have high sensitivity in detection on postnatal depression. To evaluate 
the postpartum depressive symptoms, pre (1 month postpartum) and post (2 months 
postpartum) EPDS will be compared between the two groups. 
3 Selection and Withdrawal of Subjects 
Study population 
To be eligible for inclusion in the RCT, participants must be (1) 18 years of age or older, (2) primiparous 
mothers, (3) intention to breastfeed, (4) low breastfeeding self-efficacy score (between 14 and 32), (5) 
singleton pregnancy, (6) term infant (37-42 weeks gestational), (7) Cantonese speaking, (8) HK resident 
and (9) mother with no serious medical or obstetrical complications. 
 
Participants will be excluded from the study if they fail to meet these criteria and/or if their baby: (1) is 
<37 weeks gestation, (2) has an Apgar score <8 at five minutes, (3) has a birthweight <2500 grams, (4) 
has any severe medical conditions or congenital malformations, (5) is placed in the special care baby unit 
for more than 48 hours after birth, or (6) is placed in the neonatal intensive care unit at any time after 
birth. 
4 Treatment of Subjects 
The team members have successfully trained 60 PCs from our previous project. The training programme 
comprised of 20 hours of classroom teaching and practical sessions at Queen Elizabeth Hospital and the 
Maternal Child Health Centres (MCHCs). The training programme was conducted by UNICEF and La 
Leche League covering topics such as (1) why breastfeeding is important, (2) how to assure good start of 
breastfeeding, (3) how to help mother breastfeeding (4) communication skills, (5) common 
breastfeeding problems, (6) diet and hygiene, (7) maternal illness and needs, (8) local support and role 
of peer counsellors.  The peer counsellors was assessed by their trainers after completing the training 
programme. Those who pass the assessment can then carry out volunteer work using train the trainer 
approach with supervision from La Leche League in MCHCs. Additional training workshop will be 
arranged for the PCs on solving problems of exclusive breastfeeding and correct breastfeeding technique 
by team leaders. 
 
The intervention will be based on the PC programme previously conducted in our project except it will be 
home based (web based) peer support programme by trained PCs. In order to ensure the quality and 
consistency of intervention, additional training tailored to issues that may encouter in (web-based) 
home-based contacts will be provided to peer counsellors before the study.  
 
The (web-based) home-based PC programme comprises of two schedule of two contacts during first 
month postpartum, one contact during 2 months postpartum, one contact during 4 months and one 
contact during 6 months postpartum, when mothers are most likely to experience difficulties with 
breastfeeding, and thereafter as needed. Both control and intervention groups will receive the same 
standard antenatal and postpartum care and a breastfeeding information leaflet. The control group will 
not receive home based PC programme but a breastfeeding information leaflet so the subjects will be 
blinded to the nature of the interventions. 

 
5 Assessment of Efficacy 
This study aims to assess effectiveness of the peer support intervention. The assessment of efficacy of the 
intervention will be undertaken at 1 month, 2 months, 4 months and 6 months postpartum using the 
criteria specified in the study outcomes.   
6 Assessment of Safety 
This research involves a patient support intervention and we do not anticipate any patient safety issues. 
The person(s) carrying out the intervention will be trained and with experience in supporting 
breastfeeding women. However, as a precaution, both the delivery of the intervention and participant 
outcomes will be closely monitored by the PI and the study investigators 
7 Statistic 
 
Data Analysis 
To compare the baseline characteristics between the two study groups, t-tests will be used for continuous 
variables and chi square test for categorical variables. Intention to treat analysis will be conducted. The 
primary outcome analyses will compare the proportions of participants in the two study groups 
exclusively breastfeeding at 1, 2, 4 and 6 months postpartum using chi square tests. To control for 
confounding factors, multiple logistic regression models will be used if required to compare 
breastfeeding rates between groups at the study follow up points. The secondary outcome analyses will 
use an independent 2-sample t tests to examine the breastfeeding self-efficacy scores and EPDS scores 
between the two study groups at baseline and at 1 and 3 months postpartum. To control for confounding 
factors, multiple linear regression models will be used to compare the scores between the groups at 3 
months.  
Where appropriate, each estimate will be accompanied by a 95% confidence interval and a 5% level of 
significance will be used in all statistical tests except where specified. The analysis will be performed 
using the Stata version 14.0 statistical software. 
8 Direct Access to Source Data/Documents 
Once data are collected, only the PI will have access to named data which will be kept locked in the PIs 
office in the School of Nursing.  Access to the study data will be available for study related monitoring, 
audit and regulatory inspection by appropriate bodies. It will also be available for IRB review as 
appropriate.  
9 Quality Control and Quality Assurance 
As part of the usual review process in the department, data analysis will be reviewed by the study team to 
ensure it is appropriate, accurate and correctly interpreted. 
10 Ethics 
The main ethical considerations for this study are to ensure confidentiality to the participants and to 
ensure that the participants feel free to either participate in the study or to not participate in the study.  
The following measures will be taken to address these concerns: 
• 
Participation is the study will be completely voluntary and potential participants will be assured 
that they will not suffer any consequences of lower standards of care for not participating.   
• 
Participants will be also informed that they may withdraw from the study at any time without 
any repercussions.   
• 
Informed written consent will be obtained from all participants. 
• 
No specific identifiers (such as name, telephone number, or address) will be included in the data 
used for analysis or be available to the study team other than the PI. Other study information 
will not be specific enough, either singly or in combination, to uniquely identify an individual.  
 
This study complies with the principles of the 1996 Declaration of Helsinki.  

11 Data Handling and Record Keeping 
Anonymised data will be analysed within the School of Nursing. All data collection forms will contain a 
study ID number only.  The only data which will be able to link the participant with the study data are 
the consent form.  All signed consent forms will be kept in the PI’s office in a locked filing cabinet. 
12 Financing and Insurance  
This research does not involve any invasive intervention or medical procedure.  The only data collected 
will be biographical and health related data using questionnaires, data collection sheets, or interviews.  
13 Publication Policy 
Papers approved by the study team will be published in appropriate peer reviewed journals.  

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