Breast Feeding, Breast Feeding, Exclusive
Conditions
Keywords
Breast Feeding, Exclusive, Infant Nutrition, Burkina Faso
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.
Interventions
BEHAVIORALA&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
Sponsors
FHI 360
Centre Muraz
AFRICSanté
London School of Hygiene and Tropical Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exclusive Breastfeeding on the Day Preceding the Interview as Assessed by Cross Sectional Survey | 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
| Measure | Time frame | Description |
|---|---|---|
| Colostrum Given as Assessed by Cross Sectional Survey | 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. |
| 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 | The proportion of newborns aged less than 6 months who received no pre-lacteal feeds before breastfeeding was established |
| 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 | The proportion of infants age 6 to 8 months who received semi-solid, solid or soft foods in the previous day. |
| 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 | 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. |
| Dietary Diversity as Assessed by Cross Sectional Survey | 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. |
| 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 | The proportion of newborns aged less than 6 months who were breastfed within 1 hour of birth. |
| Mother's Accurate Knowledge of Good Breastfeeding Practice as Assessed by Cross Sectional Survey | 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 |
| Mother's Self-reported Breastfeeding Practices as Assessed by Cross Sectional Survey | 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. |
| Mother's Perceptions and Beliefs Surrounding Breastfeeding | 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). |
| Knowledge, Beliefs and Perceptions Surrounding Breastfeeding of Family Members | 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). |
| Breast Milk on the Day Preceding the Interview as Assessed by Cross Sectional Survey | 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. |
Countries
Burkina Faso
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| A&T Intervention Communes: Baseline 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 | 1,111 |
| Control Communes: Baseline No intervention | 1,177 |
| A&T Intervention Communes: Endline 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 | 1,092 |
| Control Communes: Endline No intervention | 1,161 |
| Total | 4,541 |
Baseline characteristics
| Characteristic | Total | Control Communes: Baseline | A&T Intervention Communes: Endline | Control Communes: Endline | A&T Intervention Communes: Baseline |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 184 Participants | 49 Participants | 53 Participants | 43 Participants | 39 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4357 Participants | 1128 Participants | 1039 Participants | 1118 Participants | 1072 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — |
| Region of Enrollment Burkina Faso | 4541 participants | 1177 participants | 1092 participants | 1161 participants | 1111 participants |
| Sex: Female, Male Female | 4541 Participants | 1177 Participants | 1092 Participants | 1161 Participants | 1111 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2,203 | 0 / 2,338 |
| other Total, other adverse events | 0 / 2,203 | 0 / 2,338 |
| serious Total, serious adverse events | 0 / 2,203 | 0 / 2,338 |
Outcome results
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.
Time frame: Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017
Population: Endline survey participants with infant aged less than 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A&T Intervention Communes | Exclusive Breastfeeding on the Day Preceding the Interview as Assessed by Cross Sectional Survey | 0.933 percentage of exclusive breastfeeding |
| Control Communes | Exclusive Breastfeeding on the Day Preceding the Interview as Assessed by Cross Sectional Survey | 0.512 percentage of exclusive breastfeeding |
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.
Time frame: Infants up to 6 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.
Time frame: Infants age 6-11.9 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.
Time frame: Infants up to 6 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.
Time frame: Infants age 6-11.9 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).
Time frame: Family members of infants aged up to 12 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.
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: Mothers of infants aged up to 12 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
Time frame: 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.
Time frame: Infants age 6-8 months in a cross-sectional endline survey scheduled for April - July 2017