Alive & Thrive Nigeria Breastfeeding Promotion in Urban Private Facilities Study

April 6, 2021 updated by: RTI International

Implementation Research on an Urban Private Sector Model of IYCF Counseling in Private Health Facilities in Lagos State

The purpose of this study was to evaluate the effect of a breastfeeding promotion intervention on breastfeeding intentions, early initiation of breastfeeding, and exclusive breastfeeding among clients in private health facilities in Lagos, Nigeria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a longitudinal cohort study designed to evaluate and measure the implementation processes of a breastfeeding counseling and support intervention offered to pregnant and postpartum women in private health facilities in Lagos State, Nigeria. This study was conducted as part of the Alive & Thrive Nigeria program, implemented by FHI 360 and partners. RTI led the design, implementation, and analysis for the study, with Datametrics Associates Ltd. serving as the data collection partner in Nigeria. The study took place in 20 private health facilities. Ten facilities were assigned to intervention and 10 to comparison based on their location within the existing intervention and comparison local government areas (LGAs) for our overall impact evaluation of the Alive & Thrive program in Nigeria (NCT02975063). To be included in the study, facilities had to provide maternity and pediatric services, such as antenatal care, postnatal care, and immunizations, and be registered with the Association of General and Private Medical Practitioners of Nigeria and the Health Facility Monitoring and Accreditation Agency. To ensure that the investigators would achieve their sample size, selected facilities with a monthly average of ≥40 antenatal clients and ≥20 deliveries over 3 months. All eligible women attending antenatal care on the days of data collection were invited to participate until the target enrollment at each facility was achieved. The investigators collected survey data from a cohort of 1,200 women (600 per study arm) during the third trimester of pregnancy and when their child was 6 weeks and 24 weeks. The purpose of the surveys were to obtain data on the women's breastfeeding intentions (third trimester) and practices (6 weeks and 24 weeks), their breastfeeding knowledge and attitudes, and their exposure to the intervention. To measure implementation outcomes, the investigators conducted 180 observations of client-provider interactions among a subset of women enrolled in the study and then completed a short exit interview with the women immediately after their facility visit. In addition, the investigators conducted qualitative interviews with 20 health providers and facility managers/owners in the intervention facilities at the end of the intervention to learn about the facilitators and barriers to implementation.

Study Type

Interventional

Enrollment (Actual)

1220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
      • Lagos, Nigeria
        • Albina Majeed Clinic
      • Lagos, Nigeria
        • Ayodele Medical Centre
      • Lagos, Nigeria
        • Crystal Specialist
      • Lagos, Nigeria
        • Edmac Medical Centre
      • Lagos, Nigeria
        • Eko Hospital
      • Lagos, Nigeria
        • El-Dunamis Medical Centre
      • Lagos, Nigeria
        • Faith City Hospital
      • Lagos, Nigeria
        • Fuja Medical Centre
      • Lagos, Nigeria
        • Ilogbo Central Hospital
      • Lagos, Nigeria
        • Isalu Hospital
      • Lagos, Nigeria
        • Matador Hospital
      • Lagos, Nigeria
        • Mobonike Hospital
      • Lagos, Nigeria
        • Modupeoluwa Mat.Home
      • Lagos, Nigeria
        • Promise Medical Centre
      • Lagos, Nigeria
        • R-Jolard Hospital
      • Lagos, Nigeria
        • Rccg Ebute Metta
      • Lagos, Nigeria
        • Rccg Oke Suna
      • Lagos, Nigeria
        • Redeemed Maternity Amuwo
      • Lagos, Nigeria
        • Regina Mundi Catholic Hospital
      • Lagos, Nigeria
        • Uwemdimo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion:

  • Women ≥18 years old, third trimester
  • Current Client of a private health facility
  • Infant alive at 6 and 24 weeks postpartum

Exclusion:

  • Infant died
  • Infant unable to breastfeed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Comparison
Other: Breastfeeding promotion
The breastfeeding promotion intervention included training for health workers, interpersonal communication (in person and digital) between providers and pregnant/breastfeeding women, and mass media.
Behavioral: Breastfeeding promotion
The intervention included training of health workers in private health facilities to provide in-person breastfeeding counseling to pregnant women and women with a child <6 months during clinic visits. The health workers also offered a mobile phone support component for appointment reminders, breastfeeding SMS and WhatsApp messages, WhatsApp breastfeeding support groups, informational materials (posters and foldable pocket-sized cards), and family engagement activities. Breastfeeding-related mass media through television and radio spots was available state-wide, including to women in intervention and comparison facilities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exclusive breastfeeding
Time Frame: 6 weeks
The proportion of infants exclusively breastfed on the previous day
6 weeks
Exclusive breastfeeding
Time Frame: 24 weeks
The proportion of infants exclusively breastfed on the previous day
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early initiation of breastfeeding
Time Frame: At birth
The proportion of infants who started breastfeeding within 1 hour of birth
At birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RTI International

Collaborators

FHI 360

Investigators

  • Principal Investigator: Valerie Flax, PhD, RTI International

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2019

Primary Completion (Actual)

July 17, 2020

Study Completion (Actual)

July 17, 2020

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20576

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared publicly through Harvard Dataverse.

IPD Sharing Time Frame

January 31, 2022

IPD Sharing Access Criteria

open

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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