Trial record 4 of 647 for:
breastfeeding
Linking Microcredit, Technology, and Promotion of IYCF Breastfeeding Guidelines in Bauchi State, Nigeria
This study has been completed.
Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
University of California, Davis
Partners for Development
Alive & Thrive Small Grants Program
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01352351
First received: May 10, 2011
Last updated: February 6, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Feeding Exclusive Initiation of Breastfeeding |
Behavioral: Breastfeeding promotion intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Linking Microcredit, Technology, and Promotion of IYCF Breastfeeding Guidelines in Bauchi State, Nigeria |
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- Proportion of women who exclusively breastfeed to 6 months [ Time Frame: The outcome will be measured when the infant is 6-7 months old. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- Initiation of breastfeeding within 1 hour of birth [ Time Frame: The outcome will be measured when the infant is 6-7 months old. ] [ Designated as safety issue: No ]
- Proportion of infants who receive pre-lacteal feeds [ Time Frame: The outcome will be measured when the infant is 6-7 months old. ] [ Designated as safety issue: No ]
| Enrollment: | 485 |
| Study Start Date: | May 2011 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Breastfeeding promotion intervention
Intervention:
|
Behavioral: Breastfeeding promotion 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.
|
Eligibility| Ages Eligible for Study: | 15 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352351
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352351
Sponsors and Collaborators
University of North Carolina, Chapel Hill
University of California, Davis
Partners for Development
Alive & Thrive Small Grants Program
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 |
More Information
No publications provided by University of North Carolina, Chapel Hill
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01352351 History of Changes |
| Other Study ID Numbers: | 11-0534 |
| Study First Received: | May 10, 2011 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Institutional Review Board Nigeria: National Health Research Ethics Committee (NHREC) |
Keywords provided by University of North Carolina, Chapel Hill:
|
Breast feeding Exclusive Initiation of breastfeeding |
ClinicalTrials.gov processed this record on February 27, 2015