Clinical Research Details

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

Mona Nabulsi
mn04@aub.edu.lb

PED.MN.08
Completed- Has Results

Clinical Research - Clinical Trials (phase 0, 1,2 3 & 4)  

Phase 4  

No
Collaborators
  • Lama Charafeddine
  • Hani Tamim
  • Tamar Kabakian
  • Nadine Yehia
  • Saadieh Masri
Sponsors
  • Medical Dean's Programs Project in Biomedical research Grant
Conditions and Keywords
Breastfeeding
Breastfeeding, Lay support, Cost analysis, Lactation support, Knowledge, Attitudes, Social Network and Social Support Theory.
Study Design
Health Services Research
N/A: Not Applicable
Prospective
Single Blind 
Parallel-Group
Randomized
N/A: Not Applicable
Eligibility and IRB
Female
Min: 18
Max: 45
Yes
Yes

 

A randomized controlled single-blind parallel-arm clinical trial to investigate whether 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.


 

Healthy pregnant women who are in their first or second trimester and who intend to breastfeed after delivery will be eligible to participate in this study.

 

 


 

Trained recruiters will be present all day in the obstetric clinics at both sites, based on a specified schedule that is agreed upon with the obstetricians, depending on availability of clients. The study recruiter will identify eligible subjects visiting the clinics and approach them directly for participation in the study. She will explain the details and the procedure of the study, and check eligibility as per the inclusion and exclusion criteria. Subjects will be given the informed consent forms to read at leisure and will be encouraged to ask questions. They will also be given the recruiters telephone number should they wish to call later for consent or questions. Women will be interviewed in the privacy of a specified space dedicated for the study interviewers in each clinic.


 

1- Eligible pregnant women will be recruited from two health care centers in Beirut, Lebanon: the Women’s Health Center of the American University of Beirut Medical Center (AUBMC), and the Obstetrics Clinics of Sahel General Hospital (SGH).

2-  Support mothers recruited from the community to provide new mothers with breastfeeding support. Inclusion criteria are: history of successful breastfeeding of at least one child for 2 months, positive feelings about breastfeeding, able to attend two half-day training sessions to learn how to support new mothers and when to refer to professional resources, and can read and write Arabic (middle school level).


 Premature delivery.

Critical illness in baby

Twin gestation