- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01352351
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
Status
Completed
Intervention / Treatment
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:
|
|
|
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.
Collaborators
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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