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| Name | Class |
|---|---|
| FHI 360 | OTHER |
| Centre Muraz | OTHER |
| AFRICSanté | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A&T Intervention Communes | Experimental |
| |
| Control Communes | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A&T infant and young child feeding intervention | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Colostrum Given as Assessed by Cross Sectional Survey |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Veronique Filippi | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AFRICSanté | Bobo-Dioulasso | 01 BP 298 | Burkina Faso | |||
| Centre Muraz Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30784636 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | A&T Intervention Communes | Communes where the A&T infant and young child feeding intervention was implemented:
|
| FG001 | Control Communes | No intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Survey |
| |||||||||||||
| Endline Survey |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A&T Intervention Communes: Baseline | Communes where the A&T infant and young child feeding intervention was implemented:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Endline survey participants with infant aged less than 6 months | Posted | Number | 95% Confidence Interval | percentage of exclusive breastfeeding | Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017 |
|
Two cross sectional surveys: baseline (2015) & endline (2017)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A&T Intervention Communes | Communes where the A&T infant and young child feeding intervention was implemented:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Veronique Filippi | London School of Hygiene & Tropical Medicine | +44 (0)20 7927 2874 | veronique.filippi@lshtm.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2015 | Apr 4, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Mother's Accurate Knowledge of Good Breastfeeding Practice as Assessed by Cross Sectional Survey | Mother's accurate knowledge of:
| 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 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 |
| 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 |
| 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 |
| Bobo-Dioulasso |
| Burkina Faso |
| NOT COMPLETED |
|
| BG001 | Control Communes: Baseline | No intervention |
| BG002 | A&T Intervention Communes: Endline | Communes where the A&T infant and young child feeding intervention was implemented:
|
| BG003 | Control Communes: Endline | No intervention |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Communes | No intervention |
|
|
| 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. | Not Posted | Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017 | Participants |
| Secondary | Colostrum Given as Assessed by Cross Sectional Survey | The proportion of newborns aged less than 6 months who were given colostrum. | Not Posted | Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017 | Participants |
| 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 | Not Posted | Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017 | Participants |
| 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. | Not Posted | Infants age 6-8 months in a cross-sectional endline survey scheduled for April - July 2017 | Participants |
| 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. | Not Posted | Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017 | Participants |
| Secondary | Dietary Diversity as Assessed by Cross Sectional Survey | Dietary diversity among infants age 6 to 11.9 months. | Not Posted | Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017 | Participants |
| 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. | Not Posted | Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017 | Participants |
| Secondary | Mother's Accurate Knowledge of Good Breastfeeding Practice as Assessed by Cross Sectional Survey | Mother's accurate knowledge of:
| Not Posted | Mothers of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017 | Participants |
| 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. | Not Posted | Mothers of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017 | Participants |
| Secondary | Mother's Perceptions and Beliefs Surrounding Breastfeeding | Mother's perceptions and beliefs about breastfeeding (qualitative component). | Not Posted | Mothers of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017 | Participants |
| 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). | Not Posted | Family members of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017 | Participants |
| 0 |
| 2,203 |
| 0 |
| 2,203 |
| 0 |
| 2,203 |
| EG001 | Control Communes | No intervention | 0 | 2,338 | 0 | 2,338 | 0 | 2,338 |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|