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Alive & Thrive Evaluation in Burkina Faso

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ClinicalTrials.gov Identifier: NCT02435524
Recruitment Status : Completed
First Posted : May 6, 2015
Results First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborators:
FHI 360
Centre Muraz
AFRICSanté
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

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.


Condition or disease Intervention/treatment Phase
Breast Feeding Breast Feeding, Exclusive Behavioral: A&T infant and young child feeding intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4541 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Alive & Thrive Evaluation in Burkina Faso
Actual Study Start Date : June 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: A&T Intervention Communes Behavioral: A&T infant and young child feeding intervention
  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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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).

  11. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435524


Locations
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Burkina Faso
AFRICSanté
Bobo-Dioulasso, Burkina Faso, 01 BP 298
Centre Muraz Research Institute
Bobo-Dioulasso, Burkina Faso
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
FHI 360
Centre Muraz
AFRICSanté
Investigators
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Principal Investigator: Veronique Filippi London School of Hygiene and Tropical Medicine
  Study Documents (Full-Text)

Documents provided by London School of Hygiene and Tropical Medicine:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02435524    
Other Study ID Numbers: 9066
First Posted: May 6, 2015    Key Record Dates
Results First Posted: December 4, 2018
Last Update Posted: December 4, 2018
Last Verified: August 2017
Keywords provided by London School of Hygiene and Tropical Medicine:
Breast Feeding, Exclusive
Infant Nutrition
Burkina Faso