A complex breastfeeding promotion and support intervention in a developing country
- Conditions
- Breastfeeding practice in the first six months postpartumPregnancy and Childbirth
- Registration Number
- ISRCTN17875591
- Lead Sponsor
- American University of Beirut (Lebanon)
- Brief Summary
2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/24428951 protocol 2019 Results article in http://www.ncbi.nlm.nih.gov/pubmed/31199849 results (added 05/07/2019) 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28099043 substudy results (added 11/07/2019) 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27565201 substudy results (added 11/07/2019) 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/25944647 substudy results (added 11/07/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31644569 substudy results (added 24/10/2019) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32517707/ questionnaire validation (added 15/06/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32886727/ results (added 07/09/2020) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/39028742/ Cost-benefit analysis (added 22/07/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 362
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)
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent difference in 6-month breastfeeding exclusivity rates between the intervention and control groups. <br><br>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
Name Time Method Differences between the two study groups with respect to the following: <br>1. Breastfeeding exclusivity rates at 1 and 3 months<br>2. Breastfeeding continuity rates at 1, 3 and 6 months<br>3. Breastfeeding knowledge and attitudes of mothers at 6 months<br>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<br>5. Cost-benefit analysis of the complex intervention<br>6. Quality of life at 1, 3 and 6 months<br>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<br><br>For secondary outcomes, we will use validated questionnaires about breastfeeding knowledge, attitude and behaviour, and the postpartum quality of life questionnaire.