Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size
Trial record 4 of 839 for:    breastfeeding
Previous Study | Return to List | Next Study

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

This study has been completed.
Sponsor:
Collaborators:
University of California, Davis
Partners for Development
The Alive & Thrive Small Grants
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
History of Changes
  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:

MedlinePlus related topics: Breastfeeding
U.S. FDA Resources

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:

  • Group breastfeeding counseling during monthly microcredit borrower group meetings
  • Weekly cell phone messages about breastfeeding
 Behavioral: Breastfeeding promotion intervention
  • 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.

  Eligibility
Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
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

Sponsors and Collaborators
University of North Carolina, Chapel Hill
University of California, Davis
Partners for Development
The Alive & Thrive Small Grants
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

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 September 27, 2016