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A complex breastfeeding promotion and support intervention in a developing country

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17875591
Enrollment
517
Registered
2013-08-12
Start date
2013-10-01
Completion date
Unknown
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding practice in the first six months postpartum Pregnancy and Childbirth

Interventions

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. Co

Sponsors

American University of Beirut (Lebanon)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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)

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Lebanon

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 21, 2026