NCT01352351

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
485

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

1.7 years

First QC Date

May 10, 2011

Last Update Submit

February 6, 2013

Conditions

Keywords

Breast feeding ExclusiveInitiation of breastfeeding

Outcome Measures

Primary Outcomes (1)

  • Proportion of women who exclusively breastfeed to 6 months

    The outcome will be measured when the infant is 6-7 months old.

Secondary Outcomes (4)

  • Proportion of women who exclusively breastfeed for 0-1 month

    The outcome will be measured when the infant is 6-7 months old.

  • Proportion of women who exclusively breastfeed for 2-3 months

    The outcome will be measured when the infant is 6-7 months old.

  • Initiation of breastfeeding within 1 hour of birth

    The outcome will be measured when the infant is 6-7 months old.

  • Proportion of infants who receive pre-lacteal feeds

    The outcome will be measured when the infant is 6-7 months old.

Study Arms (2)

Breastfeeding promotion intervention

EXPERIMENTAL

Intervention: * Group breastfeeding counseling during monthly microcredit borrower group meetings * Weekly cell phone messages about breastfeeding

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.

Interventions

* Breastfeeding counseling during monthly microcredit meetings * Weekly cell phone messages about breastfeeding

Breastfeeding promotion intervention

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Female (\<15 years)
  • Not pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2011

First Posted

May 11, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 8, 2013

Record last verified: 2013-02