Breast FeedingNCT02435524
Alive & Thrive Evaluation in Burkina Faso
A study testing A&T infant and young child feeding intervention in people with Breast Feeding and Breast Feeding, Exclusive, run by London School of Hygiene and Tropical Medicine at 2 sites in Burkina Faso.
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Breast Feeding, Exclusive
- What is being tested?
- A&T infant and young child feeding intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,541 participants
- Where
- 2 sitesBurkina Faso
- Study dates
- Jun 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Burkina Faso2 sites
AFRICSanté
Bobo-Dioulasso, 01 BP 298
Centre Muraz Research Institute
Bobo-Dioulasso
About this study
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.
- Conditions
- Breast Feeding, Breast Feeding, Exclusive
- Being tested
- A&T infant and young child feeding intervention
- Keywords
- Breast Feeding, Exclusive, Infant Nutrition, Burkina Faso
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A&T infant and young child feeding interventionBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| A&T Intervention Communes | Experimental | Not described Receives: Behavioral: A&T infant and young child feeding intervention |
| Control Communes | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017
Secondary outcomes (11)
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.
Measured: Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017
Colostrum Given as Assessed by Cross Sectional Survey
The proportion of newborns aged less than 6 months who were given colostrum.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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:
- 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Family members of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,541 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- FHI 360, Centre Muraz, AFRICSanté
- Responsible party
- Sponsor
- Investigators
- Veronique Filippi, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435524
- Sponsor's protocol ID
- 9066
- Status last verified
- Aug 2017
- First submitted
- 22 Apr 2015
- Last updated
- 4 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 30784636
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alive & Thrive Evaluation in Burkina Faso
- ClinicalTrials.gov ID
- NCT02435524
- Acronym / sponsor ID
- 9066
- Conditions
- Breast Feeding, Breast Feeding, Exclusive
- Keywords
- Breast Feeding, Exclusive, Infant Nutrition, Burkina Faso
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,541 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- FHI 360, Centre Muraz, AFRICSanté
- Study start
- Jun 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Posted 4 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A&T Intervention Communes | Experimental | Behavioral: A&T infant and young child feeding intervention |
| Control Communes | No intervention | – |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A&T infant and young child feeding intervention1. 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 | Behavioural | A&T Intervention Communes |
Primary outcome
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.
11 secondary outcomes
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
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
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
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
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
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
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
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 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 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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30784636Cresswell 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronique Filippi principal investigator
London School of Hygiene and Tropical Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A&T infant and young child feeding intervention in people with Breast Feeding and Breast Feeding, Exclusive, run by London School of Hygiene and Tropical Medicine at 2 sites in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02435524, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.