Condition category
Pregnancy and Childbirth
Date applied
20/07/2013
Date assigned
12/08/2013
Last edited
17/01/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 mother’s 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 mother’s 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mona Nabulsi

ORCID ID

Contact details

Department of Pediatrics and Adolescent Medicine
Faculty of Medicine
American University of Beirut
Beirut
1136044C8
Lebanon
mn04@aub.edu.lb

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PED.MN.08

Study information

Scientific title

A complex breastfeeding promotion and support intervention in a developing country: a randomized clinical trial

Acronym

Study hypothesis

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

American University of Beirut Institutional Review Board, March 20, 2013; IRB number PED.MN.08

Study design

Single-blind randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/10/2013

Overall trial end date

30/09/2018

Reason abandoned

Eligibility

Participant 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 six 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)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

At least 443 pregnant women and 74 support mothers

Participant 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)

Recruitment start date

01/10/2013

Recruitment end date

30/09/2018

Locations

Countries of recruitment

Lebanon

Trial participating centre

Department of Pediatrics and Adolescent Medicine
Beirut
1136044C8
Lebanon

Sponsor information

Organisation

American University of Beirut (Lebanon)

Sponsor details

Riad El-Solh
Beirut
1107 2020
Lebanon
009611350000
med@aub.edu.lb

Sponsor type

University/education

Website

http://www.aub.edu.lb

Funders

Funder type

University/education

Funder name

Medical Dean’s Program Projects in Biomedical research; American University of Beirut (Lebanon)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24428951

Publication citations

  1. Protocol

    Nabulsi M, Hamadeh H, Tamim H, Kabakian T, Charafeddine L, Yehya N, Sinno D, Sidani S, A complex breastfeeding promotion and support intervention in a developing country: study protocol for a randomized clinical trial., BMC Public Health, 2014, 14, 36, doi: 10.1186/1471-2458-14-36.

Additional files

Editorial Notes