NCT02435524

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,541

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 4, 2018

Completed
Last Updated

December 4, 2018

Status Verified

August 1, 2017

Enrollment Period

2.2 years

First QC Date

April 22, 2015

Results QC Date

May 1, 2018

Last Update Submit

December 3, 2018

Conditions

Keywords

Breast Feeding, ExclusiveInfant NutritionBurkina Faso

Outcome Measures

Primary Outcomes (1)

  • Exclusive Breastfeeding on the Day Preceding the Interview as Assessed by Cross Sectional Survey

    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 Outcomes (11)

  • Breastfeeding Within 1 Hour of Birth as Assessed by Cross Sectional Survey

    Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017

  • Colostrum Given as Assessed by Cross Sectional Survey

    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

    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

    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

    Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017

  • +6 more secondary outcomes

Study Arms (2)

A&T Intervention Communes

EXPERIMENTAL
Behavioral: A&T infant and young child feeding intervention

Control Communes

NO INTERVENTION

Interventions

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

A&T Intervention Communes

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AFRICSanté

Bobo-Dioulasso, 01 BP 298, Burkina Faso

Location

Centre Muraz Research Institute

Bobo-Dioulasso, Burkina Faso

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Results Point of Contact

Title
Dr Veronique Filippi
Organization
London School of Hygiene & Tropical Medicine

Study Officials

  • Veronique Filippi

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2015

First Posted

May 6, 2015

Study Start

June 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

December 4, 2018

Results First Posted

December 4, 2018

Record last verified: 2017-08

Locations