A complex breastfeeding promotion and support intervention in a developing country

ISRCTN	ISRCTN17875591
DOI	https://doi.org/10.1186/ISRCTN17875591
Protocol serial number	PED.MN.08
Sponsor	American University of Beirut (Lebanon)
Funder	Medical Deans Program Projects in Biomedical research; American University of Beirut (Lebanon)

Submission date: 20/07/2013
Registration date: 12/08/2013
Last edited: 22/07/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Breastfeeding has countless benefits to mothers, children and the community at large, especially in developing countries. Exclusive breastfeeding is a cost-effective preventive public health measure that has a major impact on diseases and death in infants. Research in Lebanon reports disappointingly low breastfeeding exclusivity and continuation rates. This is predominantly due to a bottle-feeding culture fuelled by mothers misconceptions such as insufficiency of breast milk and lack of satisfaction in the baby, breastfeeding causing maternal weight gain or breast sagging, harmful mothers milk during certain situations such as grief, illness or pregnancy, and breastfeeding causing pain, sleep deprivation and exhaustion. The impact of this on the public health in a country with limited healthcare resources and a burden of different diseases such as Lebanon is significant. This study aims to test whether providing breastfeeding promotion and support to pregnant women from early pregnancy until the newborn is six months of age increases exclusive breastfeeding rates at six months.

Who can participate?
Healthy pregnant women who are in their first trimester and who intend to breastfeed after delivery can participate in this study. Mothers who have breastfed at least one child for 2 months and can read and write Arabic are eligible to train as support mothers.

What does the study involve?
Pregnant women will be randomly assigned to one of two groups: either to receive the package consisting of breastfeeding education and counseling to improve their knowledge and expectations, professional support to build appropriate breastfeeding skills, and peer support through a mother-to mother breastfeeding support network, or to receive standard prenatal and postnatal care. They will be followed-up from early pregnancy to 5 years after delivery. The support package will be delivered in 10 to 14 structured scheduled visits or phone calls to the participating mother, starting from the date of enrolment, through delivery, first week after the birth, monthly up until 6 months, and then yearly for 5 years. During the visits or phone calls, information will be collected regarding mothers pregnancy and delivery, family conditions, quality of life, breastfeeding knowledge, satisfaction with the experience in being a participant in this research study, the health and nutrition of the baby, and success in breastfeeding future babies in years 3 to 5.

What are the possible benefits and risks of participating?
The benefits of this study are increased breastfeeding duration and potential improvement of the health of the mother and the baby. The study will also help researchers better understand how to improve breastfeeding rates in Lebanon, and hopefully other countries with a similar problem. There are no physical or emotional risks beyond the risks of daily life. The home visits and/or phone calls to mothers may however be foreseen as intrusion of privacy.

Where is the study run from?
The study will be conducted in maternity clinics of the American University of Beirut Medical Center and Sahel General Hospital, in Beirut, Lebanon.

When is the study starting and how long is it expected to run for?
The study will start in October 2013 and is expected to be completed in 5 years.

Who is funding the study?
The American University in Beirut (Lebanon)

Who is the main contact?
Dr Mona Nabulsi
mn04@aub.edu.lb

Contact information

Dr Mona Nabulsi
Scientific

Department of Pediatrics and Adolescent Medicine
Faculty of Medicine
American University of Beirut
Beirut
1136044C8
Lebanon

Email	mn04@aub.edu.lb

Study information

Primary study design	Interventional
Study design	Single-blind randomized clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A complex breastfeeding promotion and support intervention in a developing country: a randomized clinical trial
Study objectives	We hypothesize that a complex intervention targeting new mothers breastfeeding knowledge, skills and social support within a Social Network and Social Support theory framework will increase exclusive breastfeeding duration among women in Lebanon.
Ethics approval(s)	American University of Beirut Institutional Review Board, 20/03/2013; IRB number PED.MN.08
Health condition(s) or problem(s) studied	Breastfeeding practice in the first six months postpartum
Intervention	A. Intervention group: 1. Prenatal breastfeeding education 1.1. Antenatal classes 1.2. Pamphlet and video on breastfeeding 2. Professional lactation support 3. Social network and social support B. Control group: Standard prenatal and postnatal care Duration of interventions is 6 months, follow up period is for 5 years from delivery for data collection. This is applicable for both groups.
Intervention type	Other
Primary outcome measure(s)	Percent difference in 6-month breastfeeding exclusivity rates between the intervention and control groups. For all outcomes we will use questionnaires that will be administered at baseline and later at different time points. For the primary outcome, it is a questionnaire about infant diet at 6 months of age.
Key secondary outcome measure(s)	Differences between the two study groups with respect to the following: 1. Breastfeeding exclusivity rates at 1 and 3 months 2. Breastfeeding continuity rates at 1, 3 and 6 months 3. Breastfeeding knowledge and attitudes of mothers at 6 months 4. Success of mother-to-mother support system measured as satisfaction rates of breastfeeding mothers, support mothers, and nurses; referral rate of breastfeeding mothers to physicians, and adverse events at 6 months 5. Cost-benefit analysis of the complex intervention 6. Quality of life at 1, 3 and 6 months 7. Success in exclusive breastfeeding of future babies, measured as the percent difference in 6-month breastfeeding exclusivity rates between the two groups in subsequent babies up to 5 years later For secondary outcomes, we will use validated questionnaires about breastfeeding knowledge, attitude and behaviour, and the postpartum quality of life questionnaire.
Completion date	19/07/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	517
Total final enrolment	362
Key inclusion criteria	A. Pregnant women 1. Healthy pregnant women in their first trimester of pregnancy 2. Willing to breastfeed after delivery 3. Available during pregnancy and for 6 months postpartum B. Support mothers 1. Breastfed at least one child for 2 months 2. Has positive perceptions about breastfeeding 3. Able to attend 2 half-day training sessions to learn how to support mothers as well as when to refer mothers to professional resources 4. Can read and write Arabic (middle school level)
Key exclusion criteria	1. Pregnancy beyond the first trimester 2. Presence of chronic medical condition 3. Abnormal fetal screen (ultrasound/blood/amniocentesis) 4. Not willing to breastfeed after delivery 5. Not living in Lebanon for at least six months after delivery 6. Twin gestation 7. Preterm birth (at <37 weeks gestation)
Date of first enrolment	01/10/2013
Date of final enrolment	21/01/2016

Locations

Countries of recruitment

Lebanon

Study participating centre

Department of Pediatrics and Adolescent Medicine

Beirut
1136044C8
Lebanon

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analyzed during the current study will be available as anonimsed datasets upon request from the principal investigator Dr Mona Nabulsi, email: mn04@aub.edu.lb. Anonymised datasets will become available as of February 2021 for the subsequent five years. Relevant data will be provided to interested researchers for secondary data analyses. The participant consent did not mention data sharing plans since this was not anticipated at that time. Data sharing will be governed by a contract between the principal investigator and the requesting investigator through the Office of Grants and Contracts of the American University of Beirut.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/06/2019	05/07/2019	Yes	No
Results article	substudy results	01/05/2017	11/07/2019	Yes	No
Results article	substudy results	01/11/2016	11/07/2019	Yes	No
Results article	substudy results	01/05/2016	11/07/2019	Yes	No
Results article	substudy results	23/10/2019	24/10/2019	Yes	No
Results article	results	04/09/2020	07/09/2020	Yes	No
Protocol article	protocol	15/01/2014		Yes	No
Other publications	questionnaire validation	09/06/2020	15/06/2020	Yes	No
Other publications	Cost-benefit analysis	19/07/2024	22/07/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

22/07/2024: Publication reference added.
19/07/2021: The overall end date 31/07/2021 to 19/07/2021.
26/01/2021: The following changes have been made to the trial record:
1. The overall trial end date was changed from 31/01/2021 to 31/07/2021.
2. The intention to publish date was changed from 31/01/2019 to 31/07/2022.
07/09/2020: Publication reference added.
15/06/2020: Publication reference added.
24/10/2019: Publication reference added.
11/07/2019: Publication references added.
05/07/2019: Publication reference and total final enrolment number.
15/10/2018: The following updates were made:
1. The publication and dissemination plan was added.
2. The intention to publish date was added.
3. The participant level data was added.
12/10/2018: The following updates were made:
1. The recruitment end date was changed from 30/09/2018 to 21/01/2016
2. The overall trial end date was updated from 30/09/2018 to 31/01/2021