- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02435524
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bobo-Dioulasso, Burkina Faso, 01 BP 298
- AFRICSanté
-
Bobo-Dioulasso, Burkina Faso
- Centre Muraz Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
|
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:
|
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
Investigators
- Principal Investigator: Veronique Filippi, London School of Hygiene and Tropical Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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