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

NCT ID: NCT01352351

Last Updated: 2013-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

485 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Feeding Exclusive Initiation of Breastfeeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Breastfeeding promotion intervention

Intervention:

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

Group Type EXPERIMENTAL

Breastfeeding promotion intervention

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Breastfeeding promotion intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Davis

OTHER

Sponsor Role collaborator

Partners for Development

UNKNOWN

Sponsor Role collaborator

The Alive & Thrive Small Grants

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Margaret E. Bentley, PhD

Role: PRINCIPAL_INVESTIGATOR

Carolina Population Center, University of North Carolina at Chapel Hill

Valerie L. Flax, PhD

Role: PRINCIPAL_INVESTIGATOR

Carolina Population Center, University of North Carolina at Chapel Hill

Mekebeb Negerie, DrPH

Role: PRINCIPAL_INVESTIGATOR

Partners for Development/Nigeria

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24812071 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11-0534

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Breastfeeding - a Good Start Together
NCT05311631 ACTIVE_NOT_RECRUITING NA
Breast Versus Bottle Study
NCT03704051 COMPLETED
Efficacy Of Web-based Breastfeeding Education
NCT06443801 ENROLLING_BY_INVITATION NA
Prenatal Breastfeeding Education
NCT04549129 WITHDRAWN NA