Linking Microcredit, Technology, and Promotion of IYCF Breastfeeding Guidelines in Bauchi State, Nigeria

February 6, 2013 updated by: University of North Carolina, Chapel Hill
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

485

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breastfeeding promotion intervention

Intervention:

  • Group breastfeeding counseling during monthly microcredit borrower group meetings
  • Weekly cell phone messages about breastfeeding
  • Breastfeeding counseling during monthly microcredit meetings
  • Weekly cell phone messages about breastfeeding
No Intervention: No intervention
The no intervention group will participate in their regular microcredit borrower group meetings, but will not receive breastfeeding counseling or cell phone messages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of women who exclusively breastfeed to 6 months
Time Frame: The outcome will be measured when the infant is 6-7 months old.
The outcome will be measured when the infant is 6-7 months old.

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of women who exclusively breastfeed for 0-1 month
Time Frame: The outcome will be measured when the infant is 6-7 months old.
The outcome will be measured when the infant is 6-7 months old.
Proportion of women who exclusively breastfeed for 2-3 months
Time Frame: The outcome will be measured when the infant is 6-7 months old.
The outcome will be measured when the infant is 6-7 months old.
Initiation of breastfeeding within 1 hour of birth
Time Frame: The outcome will be measured when the infant is 6-7 months old.
The outcome will be measured when the infant is 6-7 months old.
Proportion of infants who receive pre-lacteal feeds
Time Frame: The outcome will be measured when the infant is 6-7 months old.
The outcome will be measured when the infant is 6-7 months old.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Margaret E. Bentley, PhD, Carolina Population Center, University of North Carolina at Chapel Hill
  • Principal Investigator: Valerie L. Flax, PhD, Carolina Population Center, University of North Carolina at Chapel Hill
  • Principal Investigator: Mekebeb Negerie, DrPH, Partners for Development/Nigeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 10, 2011

First Submitted That Met QC Criteria

May 10, 2011

First Posted (Estimate)

May 11, 2011

Study Record Updates

Last Update Posted (Estimate)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 6, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 11-0534

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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