Alive & Thrive Evaluation in Burkina Faso

The time between birth and age 24 months provides a unique opportunity to impact the long-term health and development of children through improved infant and young child feeding practices. In Burkina Faso, the prevalence of exclusive breastfeeding is currently around 25% in infants younger than six months.

The purpose of this study is to evaluate whether the Alive & Thrive intervention package, consisting of interpersonal counselling and community mobilisation activities, can increase the exclusive breastfeeding rate among infants younger than six months to at least 50% using a cluster randomised design.

Study Overview

Study Type

Interventional

Enrollment (Actual)

4541

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

      • Bobo-Dioulasso, Burkina Faso, 01 BP 298
        • AFRICSanté
      • Bobo-Dioulasso, Burkina Faso
        • Centre Muraz Research Institute

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

Female

Description

Inclusion Criteria:

  • Gives informed consent
  • Being aged from 15 to 49 years old (women of reproductive age)
  • Has at least one infant less than 12 months old who is currently alive and lives with her.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A&T Intervention Communes
  1. Interpersonal communication delivered by community workers and volunteers during home visits and at monthly mother's group meetings to:

    • Increase mother's knowledge about optimal breastfeeding and its benefits
    • Increase mother's self-efficacy related to breastfeeding
    • Improve mother's perceptions about social norms relating to breastfeeding
  2. Community mobilisation activities to:

    - Raise awareness of the benefits of optimal breastfeeding among opinion leaders, and family members, and increase the support they provide to breastfeeding mothers

  3. Enhanced training of government health workers in infant and young child feeding to:

    • Improve their ability to support mothers and provide timely information about infant feeding
No Intervention: Control Communes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exclusive Breastfeeding on the Day Preceding the Interview as Assessed by Cross Sectional Survey
Time Frame: Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017
The percentage of infants aged less than 6 months who were exclusively breastfed on the day preceding the interview.
Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding Within 1 Hour of Birth as Assessed by Cross Sectional Survey
Time Frame: Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017
The proportion of newborns aged less than 6 months who were breastfed within 1 hour of birth.
Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017
Colostrum Given as Assessed by Cross Sectional Survey
Time Frame: Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017
The proportion of newborns aged less than 6 months who were given colostrum.
Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017
Pre-lacteal Feeds as Assessed by Cross Sectional Survey
Time Frame: Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017
The proportion of newborns aged less than 6 months who received no pre-lacteal feeds before breastfeeding was established
Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017
Semi-solid, Solid or Soft Foods Consumed in the Previous Day as Assessed by Cross Sectional Survey
Time Frame: Infants age 6-8 months in a cross-sectional endline survey scheduled for April - July 2017
The proportion of infants age 6 to 8 months who received semi-solid, solid or soft foods in the previous day.
Infants age 6-8 months in a cross-sectional endline survey scheduled for April - July 2017
Minimum Acceptable Diet (Apart From Breast Milk) on the Day Preceding Interview as Assessed by Cross Sectional Survey
Time Frame: Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017
The proportion of infants aged 6 to 11.9 months who received a minimum acceptable diet (apart from breast milk) on the day preceding interview.
Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017
Dietary Diversity as Assessed by Cross Sectional Survey
Time Frame: Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017
Dietary diversity among infants age 6 to 11.9 months.
Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017
Breast Milk on the Day Preceding the Interview as Assessed by Cross Sectional Survey
Time Frame: Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017
The proportion of children aged 6 to 11.9 months who were fed breast milk on the day preceding the interview.
Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017
Mother's Accurate Knowledge of Good Breastfeeding Practice as Assessed by Cross Sectional Survey
Time Frame: Mothers of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017

Mother's accurate knowledge of:

  • Optimal timing of breastfeeding initiation
  • Optimal duration of exclusive breastfeeding
  • Benefits of optimal breastfeeding practices for the infant
  • Solutions to common difficulties, for example engorgement, cracked and sore nipples
  • Optimal timing to introduce complementary feeding
  • Optimal dietary diversity and frequency of complementary feeding up to 12 months
Mothers of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017
Mother's Self-reported Breastfeeding Practices as Assessed by Cross Sectional Survey
Time Frame: Mothers of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017
Mother's self-reported breastfeeding practices, including asking her if she experiences any barriers or difficulties with breastfeeding such as engorgement, cracked and sore nipples, or breastfeeding when working outside of the home.
Mothers of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017
Mother's Perceptions and Beliefs Surrounding Breastfeeding
Time Frame: Mothers of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017
Mother's perceptions and beliefs about breastfeeding (qualitative component).
Mothers of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017
Knowledge, Beliefs and Perceptions Surrounding Breastfeeding of Family Members
Time Frame: Family members of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017
Knowledge, beliefs and perceptions of family members, such as mothers or mothers in law, community opinion leaders towards optimal infant and child feeding practices (qualitative component).
Family members of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Veronique Filippi, London School of Hygiene and Tropical Medicine

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.

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)

June 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

May 1, 2015

First Posted (Estimate)

May 6, 2015

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 3, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 9066 (Minnesota Medical Foundataion)

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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