Alive & Thrive Evaluation in Burkina Faso

Breast Feeding Clinical Trial

Official title:

Alive & Thrive Evaluation in Burkina Faso

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435524
• Other study ID #: 9066
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4541
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Feeding
• Breast Feeding, Exclusive

Intervention

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

Locations

Country	Name	City	State
Burkina Faso	AFRICSanté	Bobo-Dioulasso
Burkina Faso	Centre Muraz Research Institute	Bobo-Dioulasso

Sponsors (4)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	AFRICSanté, Centre Muraz, FHI 360

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Breastfeeding Within 1 Hour of Birth as Assessed by Cross Sectional Survey	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
Secondary	Colostrum Given as Assessed by Cross Sectional Survey	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
Secondary	Pre-lacteal Feeds as Assessed by Cross Sectional Survey	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
Secondary	Semi-solid, Solid or Soft Foods Consumed in the Previous Day as Assessed by Cross Sectional Survey	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
Secondary	Minimum Acceptable Diet (Apart From Breast Milk) on the Day Preceding Interview as Assessed by Cross Sectional Survey	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
Secondary	Dietary Diversity as Assessed by Cross Sectional Survey	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
Secondary	Breast Milk on the Day Preceding the Interview as Assessed by Cross Sectional Survey	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
Secondary	Mother's Accurate Knowledge of Good Breastfeeding Practice as Assessed by Cross Sectional Survey	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
Secondary	Mother's Self-reported Breastfeeding Practices as Assessed by Cross Sectional Survey	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
Secondary	Mother's Perceptions and Beliefs Surrounding Breastfeeding	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
Secondary	Knowledge, Beliefs and Perceptions Surrounding Breastfeeding of Family Members	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