Clinical trial NCT02435524: Alive & Thrive Evaluation in Burkina Faso
Official title: Alive & Thrive Evaluation in Burkina Faso
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Breast Feeding, Exclusive
Keywords: Breast Feeding, Exclusive
Infant Nutrition
Burkina Faso
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: FHI 360
name: Centre Muraz
name: AFRICSanté
First posted: 2015-05-06
Enrollment: 4541
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Exclusive Breastfeeding on the Day Preceding the Interview as Assessed by Cross Sectional Survey
timeFrame: Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017
Secondary outcomes:
measure: Breastfeeding Within 1 Hour of Birth as Assessed by Cross Sectional Survey
timeFrame: Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017
measure: Colostrum Given as Assessed by Cross Sectional Survey
timeFrame: Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017
measure: Pre-lacteal Feeds as Assessed by Cross Sectional Survey
timeFrame: Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017
measure: Semi-solid, Solid or Soft Foods Consumed in the Previous Day as Assessed by Cross Sectional Survey
timeFrame: Infants age 6-8 months in a cross-sectional endline survey scheduled for April - July 2017
measure: Minimum Acceptable Diet (Apart From Breast Milk) on the Day Preceding Interview as Assessed by Cross Sectional Survey
timeFrame: Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017
measure: Dietary Diversity as Assessed by Cross Sectional Survey
timeFrame: Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017
measure: Breast Milk on the Day Preceding the Interview as Assessed by Cross Sectional Survey
timeFrame: Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017
measure: Mother's Accurate Knowledge of Good Breastfeeding Practice as Assessed by Cross Sectional Survey
timeFrame: Mothers of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017
measure: Mother's Self-reported Breastfeeding Practices as Assessed by Cross Sectional Survey
timeFrame: Mothers of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017
measure: Mother's Perceptions and Beliefs Surrounding Breastfeeding
timeFrame: Mothers of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017
measure: Knowledge, Beliefs and Perceptions Surrounding Breastfeeding of Family Members
timeFrame: Family members of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: AFRICSanté
city: Bobo-Dioulasso
country: Burkina Faso
facility: Centre Muraz Research Institute
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Veronique Filippi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cresswell JA, Ganaba R, Sarrassat S, Some H, Diallo AH, Cousens S, Filippi V. The effect of the Alive & Thrive initiative on exclusive breastfeeding in rural Burkina Faso: a repeated cross-sectional cluster randomised controlled trial. Lancet Glob Health. 2019 Mar;7(3):e357-e365. doi: 10.1016/S2214-109X(18)30494-7.