Breast Feeding Exclusive Clinical Trial
Official title:
Linking Microcredit, Technology, and Promotion of IYCF Breastfeeding Guidelines in Bauchi State, Nigeria
The University of North Carolina (UNC) and Partners for Development (PFD), an American non-governmental organization, will conduct a 2-year cluster-randomized controlled trial in Bauchi State, Nigeria, to test the effectiveness of two behavior change strategies for increasing the proportion of participants who exclusively breastfeed their infants until 6 months. The investigators will build upon PFD's existing microcredit and reproductive health program by adding face-to-face breastfeeding education during borrowers' meetings and bi-weekly cell phone breastfeeding messages. The hypothesis is that the control group will remain at the baseline level for exclusive breastfeeding to 6 months, while the intervention group will increase by 15%. The investigators will measure the effectiveness of the intervention by conducting baseline and final surveys with a cohort of 485 female borrowers who are pregnant at time 1 and who have a 6-month-old infant at time 2. The data will be analyzed using logistic regression adjusting for possible confounders and the effect of clustering.
| Status | Completed |
| Enrollment | 485 |
| Est. completion date | January 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 15 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - Participation in a microcredit borrower group sponsored by Partners for Development in Bauchi, Dass, or Ganjuwa Local Government Authority in Bauchi State, Nigeria - Female (15-45 years) - Pregnant at baseline Exclusion Criteria: - Female (<15 years) - Not pregnant |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of North Carolina, Chapel Hill | Partners for Development, The Alive & Thrive Small Grants, University of California, Davis |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of women who exclusively breastfeed to 6 months | The outcome will be measured when the infant is 6-7 months old. | No | |
| Secondary | Proportion of women who exclusively breastfeed for 0-1 month | The outcome will be measured when the infant is 6-7 months old. | No | |
| Secondary | Proportion of women who exclusively breastfeed for 2-3 months | The outcome will be measured when the infant is 6-7 months old. | No | |
| Secondary | Initiation of breastfeeding within 1 hour of birth | The outcome will be measured when the infant is 6-7 months old. | No | |
| Secondary | Proportion of infants who receive pre-lacteal feeds | The outcome will be measured when the infant is 6-7 months old. | No |