Trial Outcomes & Findings for Alive & Thrive Evaluation in Burkina Faso (NCT NCT02435524)
NCT ID: NCT02435524
Last Updated: 2018-12-04
Results Overview
The percentage of infants aged less than 6 months who were exclusively breastfed on the day preceding the interview.
COMPLETED
NA
4541 participants
Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017
2018-12-04
Participant Flow
Rural communes were randomised in this study. There are 47 communes in Boucle du Mouhoun; 6 urban communes were excluded leaving 41 rural communes to be randomised to either the intervention or control arm. Of these, 2 intervention and 2 control communes were excluded due to co-intervention.
Unit of analysis: Communes
Participant milestones
| Measure |
A&T Intervention Communes
Communes where the A\&T infant and young child feeding intervention was implemented:
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
|
Control Communes
No intervention
|
|---|---|---|
|
Baseline Survey
STARTED
|
1111 18
|
1177 19
|
|
Baseline Survey
COMPLETED
|
1111 18
|
1177 19
|
|
Baseline Survey
NOT COMPLETED
|
0 0
|
0 0
|
|
Endline Survey
STARTED
|
1092 18
|
1161 19
|
|
Endline Survey
COMPLETED
|
1092 18
|
1161 19
|
|
Endline Survey
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
A&T Intervention Communes: Baseline
n=1111 Participants
Communes where the A\&T infant and young child feeding intervention was implemented:
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
|
Control Communes: Baseline
n=1177 Participants
No intervention
|
A&T Intervention Communes: Endline
n=1092 Participants
Communes where the A\&T infant and young child feeding intervention was implemented:
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
|
Control Communes: Endline
n=1161 Participants
No intervention
|
Total
n=4541 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
39 Participants
n=1111 Participants
|
49 Participants
n=1177 Participants
|
53 Participants
n=1092 Participants
|
43 Participants
n=1161 Participants
|
184 Participants
n=4541 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1072 Participants
n=1111 Participants
|
1128 Participants
n=1177 Participants
|
1039 Participants
n=1092 Participants
|
1118 Participants
n=1161 Participants
|
4357 Participants
n=4541 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1111 Participants
|
0 Participants
n=1177 Participants
|
0 Participants
n=1092 Participants
|
0 Participants
n=1161 Participants
|
0 Participants
n=4541 Participants
|
|
Sex: Female, Male
Female
|
1111 Participants
n=1111 Participants
|
1177 Participants
n=1177 Participants
|
1092 Participants
n=1092 Participants
|
1161 Participants
n=1161 Participants
|
4541 Participants
n=4541 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1111 Participants
|
0 Participants
n=1177 Participants
|
0 Participants
n=1092 Participants
|
0 Participants
n=1161 Participants
|
0 Participants
n=4541 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Burkina Faso
|
1111 participants
n=1111 Participants
|
1177 participants
n=1177 Participants
|
1092 participants
n=1092 Participants
|
1161 participants
n=1161 Participants
|
4541 participants
n=4541 Participants
|
PRIMARY outcome
Timeframe: Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017Population: Endline survey participants with infant aged less than 6 months
The percentage of infants aged less than 6 months who were exclusively breastfed on the day preceding the interview.
Outcome measures
| Measure |
Control Communes
n=584 Participants
No intervention
|
A&T Intervention Communes
n=552 Participants
Communes where the A\&T infant and young child feeding intervention was implemented:
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
|
|---|---|---|
|
Exclusive Breastfeeding on the Day Preceding the Interview as Assessed by Cross Sectional Survey
|
0.512 percentage of exclusive breastfeeding
Interval 0.421 to 0.603
|
0.933 percentage of exclusive breastfeeding
Interval 0.9 to 0.97
|
SECONDARY outcome
Timeframe: Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017The proportion of newborns aged less than 6 months who were breastfed within 1 hour of birth.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017The proportion of newborns aged less than 6 months who were given colostrum.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017The proportion of newborns aged less than 6 months who received no pre-lacteal feeds before breastfeeding was established
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Infants age 6-8 months in a cross-sectional endline survey scheduled for April - July 2017The proportion of infants age 6 to 8 months who received semi-solid, solid or soft foods in the previous day.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017The proportion of infants aged 6 to 11.9 months who received a minimum acceptable diet (apart from breast milk) on the day preceding interview.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017Dietary diversity among infants age 6 to 11.9 months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017The proportion of children aged 6 to 11.9 months who were fed breast milk on the day preceding the interview.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Mothers of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017Mother'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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Mothers of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017Mother'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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Mothers of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017Mother's perceptions and beliefs about breastfeeding (qualitative component).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Family members of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017Knowledge, 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).
Outcome measures
Outcome data not reported
Adverse Events
A&T Intervention Communes
Control Communes
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Veronique Filippi
London School of Hygiene & Tropical Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place