Clinical trial NCT01352351: Linking Microcredit, Technology, and Promotion of IYCF Breastfeeding Guidelines in Bauchi State, Nigeria
Official title: Linking Microcredit, Technology, and Promotion of IYCF Breastfeeding Guidelines in Bauchi State, Nigeria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding Exclusive
Initiation of Breastfeeding
Keywords: Breast feeding Exclusive
Initiation of breastfeeding
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of California, Davis
name: Partners for Development
name: The Alive & Thrive Small Grants
First posted: 2011-05-11
Enrollment: 485
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of women who exclusively breastfeed to 6 months
timeFrame: The outcome will be measured when the infant is 6-7 months old.
Secondary outcomes:
measure: Proportion of women who exclusively breastfeed for 0-1 month
timeFrame: The outcome will be measured when the infant is 6-7 months old.
measure: Proportion of women who exclusively breastfeed for 2-3 months
timeFrame: The outcome will be measured when the infant is 6-7 months old.
measure: Initiation of breastfeeding within 1 hour of birth
timeFrame: The outcome will be measured when the infant is 6-7 months old.
measure: Proportion of infants who receive pre-lacteal feeds
timeFrame: The outcome will be measured when the infant is 6-7 months old.
Other outcomes:
Locations:
Study officials:
affiliation: Carolina Population Center, University of North Carolina at Chapel Hill
name: Margaret E. Bentley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carolina Population Center, University of North Carolina at Chapel Hill
name: Valerie L. Flax, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Partners for Development/Nigeria
name: Mekebeb Negerie, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flax VL, Negerie M, Ibrahim AU, Leatherman S, Daza EJ, Bentley ME. Integrating group counseling, cell phone messaging, and participant-generated songs and dramas into a microcredit program increases Nigerian women's adherence to international breastfeeding recommendations. J Nutr. 2014 Jul;144(7):1120-4. doi: 10.3945/jn.113.190124. Epub 2014 May 8.