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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Breast Feeding Exclusive; Initiation of Breastfeeding	Behavioral: Breastfeeding promotion intervention	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	485 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Linking Microcredit, Technology, and Promotion of IYCF Breastfeeding Guidelines in Bauchi State, Nigeria
Study Start Date :	May 2011
Actual Primary Completion Date :	January 2013
Actual Study Completion Date :	January 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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. ]
2. 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. ]
3. Initiation of breastfeeding within 1 hour of birth [ Time Frame: The outcome will be measured when the infant is 6-7 months old. ]
4. Proportion of infants who receive pre-lacteal feeds [ Time Frame: The outcome will be measured when the infant is 6-7 months old. ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT01352351 History of Changes
Other Study ID Numbers:	11-0534
First Posted:	May 11, 2011
Last Update Posted:	February 8, 2013
Last Verified:	February 2013

Keywords provided by University of North Carolina, Chapel Hill:

Breast feeding Exclusive; Initiation of breastfeeding