PovertyPhase 4JigisemejiriNCT02858011
The Effect of a Cash Transfer Program and Preventive Nutrition Packages on Household Welfare and Child Nutritional Status in Mali
A Phase 4 study testing Cash distribution during first 36 months, Accompanying information sessions on health, child nutrition, household economics and education during first 36 months and Preventive Nutrition Packages during last 12 months in people with Poverty and Child Malnutrition, run by International Food Policy Research Institute at 1 site in Mali.
Trial summary
In the last two decades, cash transfer (CT) programs have emerged as a popular approach to long-term poverty alleviation. While the main goal of cash transfer programs is to reduce poverty, they also have the potential to improve many development outcomes, such as health and education. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Poverty, Child Malnutrition
- What is being tested?
- Cash distribution during first 36 months, Accompanying information sessions on health, child nutrition, household economics and education during first 36 months and Preventive Nutrition Packages during last 12 months
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,320 participants
- Where
- 1 siteMali
- Study dates
- Sep 2014to 10 Aug 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being a Household that is beneficiary of the Jigisemejiri program
- Having a child between 6 and 24 months of age
Who cannot join
- Congenital malformations that hamper anthropometric measurements
Trial locations and contacts
1 site in 1 country.
About this study
In the last two decades, cash transfer (CT) programs have emerged as a popular approach to long-term poverty alleviation. While the main goal of cash transfer programs is to reduce poverty, they also have the potential to improve many development outcomes, such as health and education.
While many studies, mainly in Latin America and Asia, have investigated the impacts of CTs on poverty and food security and have, for the most part, found positive impacts, less is known about the impacts of CTs in Africa south of the Sahara, and, in particular, West Africa. Moreover, despite the fact that cash transfers have been shown to lead to decreases in poverty, improvements in household food security, and increases in health service utilization, impacts on children's nutritional status (including anthropometric measures) are generally small (Manley, Gitter, and Slavchevska 2013). Consequently, policymakers and governments are left with the question of how to design social safety nets, such as cash transfers, to achieve greater impact on diet quality, health, and nutrition.
Read more
The overall goal of this research is to generate evidence and knowledge on an integrated program implemented by the Government of Mali that includes a combination of cash transfers and targeted nutrition interventions. The information generated will inform program implementers and policymakers about best options to improve food security and nutrition among vulnerable groups and individuals in West Africa. Specifically, the main objectives of the research are
- To provide evidence on the contribution of integrated social transfer programs to enhancing household welfare, food security, dietary diversity, and maternal and child nutrition in West Africa.
- To test different features and combinations of cash transfers and targeted nutrition interventions, and assess their impact on food security and maternal and child nutrition and health outcomes in Mali.
- To generate knowledge regarding the pathways of impact of these different program packages, identify the most effective and efficient modalities in the context of Mali, and derive lessons learned for other countries in the region.
Read the detailed description
The research entails two study designs: i) a repeated cross-sectional survey (baseline, midline and endline) in a sample of 1,440 children between 6 and 24 months of age, mainly to asses the program's impact on child nutrition and health outcomes; ii) a panel study following a cohort of 2,880 children over 3 years mainly focusing on the evaluation of household welfare outcomes. The study will be conducted in the 96 communes where the Jigisemejiri program is being implemented, situated in 5 regions of Mali: Sikasso, Koulikoro, Segou, Mopti and Kayes. Data will be collected at baseline (2014, T=0), midline (2016, T=~24 months) and endline (2018, T=~48 months).
The program is implemented for 48 months. The experimental group receives the cash transfer and group counselling intervention for 36 months. During the last 12 months the experimental group does not receive any intervention. The control group receives no intervention during the first 36 months, but receives the cash transfer and group counselling during the last 12 months. In a subsample of communes from the experimental group, villages were randomized to either receive Preventive Nutrition Packages (PNP) or nothing. The impact of PNP is analyzed by comparing villages that received PNP and villages that did not receive PNP during the last 12 months of the program.
- Conditions
- Poverty, Child Malnutrition
- Being tested
- Cash distribution during first 36 months, Accompanying information sessions on health, child nutrition, household economics and education during first 36 months, Preventive Nutrition Packages during last 12 months, Cash distribution during the last 12 months, Accompanying information sessions on health, child nutrition, household economics and education during the last 12 months
- Keywords
- behavior change communication, cash transfer, household welfare, child nutrition status
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cash distribution during first 36 monthsOther
Three-monthly distribution of Cash (30,000 FCFA/trimester) to households that are beneficiary of the Jigisemejiri program.
Accompanying information sessions on health, child nutrition, household economics and education during first 36 monthsBehavioural
Large group gatherings of cash beneficiaries are organized in parallel to the cash distributions. During these meetings, local NGOs present and discuss a topic related to health, child nutrition, household economics or education.
Preventive Nutrition Packages during last 12 monthsDietary supplement
Fortified flour supplements for children (Supercereal Plus)and pregnant/lactating mothers (super Cereal)
Cash distribution during the last 12 monthsOther
Three-monthly distribution of Cash (30,000 FCFA/trimester) to households that are beneficiary of the Jigisemejiri program.
Accompanying information sessions on health, child nutrition, household economics and education during the last 12 monthsBehavioural
Large group gatherings of cash beneficiaries are organized in parallel to the cash distributions. During these meetings, local NGOs present and discuss a topic related to health, child nutrition, household economics or education.
| Study group | Role | What they receive |
|---|---|---|
| Control and comparison group -cash transfer program | Active comparator | The program is implemented during 48 months. During the first 36 months the control group does not receive any intervention. During the last 12 months eligible beneficiaries receive cash transfer and accompanying information sessions on health, child nutrition, household economics every three months (identical to experimental group). Receives: Other: Cash distribution during the last 12 months; Behavioral: Accompanying information sessions on health, child nutrition, household economics and education during the last 12 months |
| Jigisemejiri cash transfer program | Experimental | Unconditional cash is distributed every 3 months to beneficiaries of the Jigisemejiri program. During cash handouts, information sessions on health, child nutrition, households economics and education are organized by local NGOs. Receives: Other: Cash distribution during first 36 months; Behavioral: Accompanying information sessions on health, child nutrition, household economics and education during first 36 months |
| Jigisemejiri - Preventive Nutrition packages | Experimental | Households belonging to the experimental group who previously received Cash transfer and information sessions on health, child nutrition, households economics and education for 36 months, with children and/or pregnant/lactating women receiving rations of fortified flour (PNP) during the last 12 months of the project Receives: Other: Cash distribution during first 36 months; Behavioral: Accompanying information sessions on health, child nutrition, household economics and education during first 36 months; Dietary Supplement: Preventive Nutrition Packages during last 12 months |
| Control and comparison group - Preventive Nutrition packages | Active comparator | Households belonging to the experimental group who previously received Cash transfer and information sessions on health, child nutrition, households economics and education for 36 months, with children and/or pregnant/lactating women Receives: Other: Cash distribution during first 36 months; Behavioral: Accompanying information sessions on health, child nutrition, household economics and education during first 36 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Height-for-age Z-score
To calculate WHZ scores the 2006 WHO growth reference will be used
Measured: After 24 months of program implementation
Value of household consumption
The household consumption includes food and non-food related economic consumption
Measured: After 24 months of program implementation
Household dietary diversity
The household dietary diversity is estimated by a dietary diversity score counting food groups
Measured: After 24 months of program implementation
Child Height-for-age Z-score
To calculate HAZ scores the 2006 WHO growth reference will be used (only in cross-sectional survey)
Measured: After 48 months of program implementation (only in cross-sectional survey)
Value of household consumption
The household consumption includes food and non-food related economic consumption
Measured: After 48 months of program implementation
Household dietary diversity
The household dietary diversity is estimated by a dietary diversity score counting food groups
Measured: After 48 months of program implementation
Child Weight-for-Height Z-score
To calculate WHZ scores the 2006 WHO growth reference will be used (only in cross-sectional survey)
Measured: After 48 months of program implementation (only in cross-sectional survey)
Secondary outcomes (22)
Child Weight-for-height Z-score
To calculate WHZ scores the 2006 WHO growth reference will be used
Measured: After 24 months of program implementation
Prevalence of child wasting
To calculate WHZ scores the 2006 WHO growth reference will be used
Measured: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Prevalence of child stunting
To calculate WHZ scores the 2006 WHO growth reference will be used
Measured: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Child hemoglobin concentration
Measured: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Prevalence of child anemia
Measured: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Body Mass Index of primary caregiver of index child
Measured: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Early child development
Measured: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Child morbidity (acute respiratory infections, fever, vomiting, diarrhea)
Measured: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Caregiver's knowledge and practices related to Infant and Young Child Feeding (IYCF), child health and hygiene
Measured: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Household assets and savings
Measured: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Educational level of Household members
Measured: After 24 months and 48 months of program implementation
Household food security
Measured by the Household Food Insecurity Access Scale (HFIAS)
Measured: After 24 months and 48 months of program implementation
Household composition
This entails the household size, the number of one parent households, monogamous and polygamous households, number of infants and children.
Measured: After 24 months and 48 months of program implementation
Household agricultural production
The composition and quantity of all crops grown by the houshold over the last year is being recalled
Measured: After 24 months and 48 months of program implementation
Cognitive function of the head of household
Measured by spatial Stroop test and digit span test (forward and backward)
Measured: After 24 months of program implementation
Well-being of household members
Well-being is assessed by measuring stress, anxiety, psychological well-being, partner violence, marital quality, depression, occurrence of disputes and resource allocation.
Measured: After 24 months and 48 months of program implementation
Women's empowerment
Measured by pro-WEAI instrument adapted to local context
Measured: After 24 months and 48 months of program implementation
Child dietary diversity
Child dietary diversity is estimated by a dietary diversity score counting food groups consumed
Measured: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Professional occupation of household members
We assess if household members have different formal and informal professional occupations or main revenue generating activities between intervention and control group
Measured: After 24 months and 48 months of program implementation
Child Mid-upper Arm Circumference
Measured: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Maternal hemoglobin concentration
Measured: After 48 months (only in cross-sectional survey) of program implementation
Maternal anemia
Measured: After 48 months (only in cross-sectional survey) of program implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startSep 2014
- Primary completion10 Aug 2019
- Study completion10 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PovertyStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,320 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche pour le Developpement, Implementation management committee of the Jigisemejiri program (Ministry of Economics and Finance, Government of Mali)
- Responsible party
- Sponsor
- Investigators
- Dan Gilligan, PhD, Study chair, IFPRIMarie Ruel, PhD, Study chair, IFPRIMelissa Hidrobo, PhD, Principal investigator, IFPRIShalini Roy, PhD, Principal investigator, IFPRILieven Huybregts, PhD, Principal investigator, IFPRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858011
- Sponsor's protocol ID
- 2014-26-PHND-M
- Acronym
- Jigisemejiri
- Status last verified
- Sep 2019
- First submitted
- 3 Aug 2016
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Cash Transfer Program and Preventive Nutrition Packages on Household Welfare and Child Nutritional Status in Mali
- ClinicalTrials.gov ID
- NCT02858011
- Acronym / sponsor ID
- Jigisemejiri / 2014-26-PHND-M
- Conditions
- Poverty, Child Malnutrition
- Keywords
- behavior change communication, cash transfer, household welfare, child nutrition status
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,320 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- Institut de Recherche pour le Developpement, Implementation management committee of the Jigisemejiri program (Ministry of Economics and Finance, Government of Mali)
- Study start
- Sep 2014
- Primary completion
- 10 Aug 2019 (actual)
- Study completion
- 10 Aug 2019 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the last two decades, cash transfer (CT) programs have emerged as a popular approach to long-term poverty alleviation. While the main goal of cash transfer programs is to reduce poverty, they also have the potential to improve many development outcomes, such as health and education.
While many studies, mainly in Latin America and Asia, have investigated the impacts of CTs on poverty and food security and have, for the most part, found positive impacts, less is known about the impacts of CTs in Africa south of the Sahara, and, in particular, West Africa. Moreover, despite the fact that cash transfers have been shown to lead to decreases in poverty, improvements in household food security, and increases in health service utilization, impacts on children's nutritional status (including anthropometric measures) are generally small (Manley, Gitter, and Slavchevska 2013). Consequently, policymakers and governments are left with the question of how to design social safety nets, such as cash transfers, to achieve greater impact on diet quality, health, and nutrition.
The overall goal of this research is to generate evidence and knowledge on an integrated program implemented by the Government of Mali that includes a combination of cash transfers and targeted nutrition interventions. The information generated will inform program implementers and policymakers about best options to improve food security and nutrition among vulnerable groups and individuals in West Africa. Specifically, the main objectives of the research are
- To provide evidence on the contribution of integrated social transfer programs to enhancing household welfare, food security, dietary diversity, and maternal and child nutrition in West Africa.
- To test different features and combinations of cash transfers and targeted nutrition interventions, and assess their impact on food security and maternal and child nutrition and health outcomes in Mali.
- To generate knowledge regarding the pathways of impact of these different program packages, identify the most effective and efficient modalities in the context of Mali, and derive lessons learned for other countries in the region.
Detailed description
The research entails two study designs: i) a repeated cross-sectional survey (baseline, midline and endline) in a sample of 1,440 children between 6 and 24 months of age, mainly to asses the program's impact on child nutrition and health outcomes; ii) a panel study following a cohort of 2,880 children over 3 years mainly focusing on the evaluation of household welfare outcomes. The study will be conducted in the 96 communes where the Jigisemejiri program is being implemented, situated in 5 regions of Mali: Sikasso, Koulikoro, Segou, Mopti and Kayes. Data will be collected at baseline (2014, T=0), midline (2016, T=~24 months) and endline (2018, T=~48 months).
The program is implemented for 48 months. The experimental group receives the cash transfer and group counselling intervention for 36 months. During the last 12 months the experimental group does not receive any intervention. The control group receives no intervention during the first 36 months, but receives the cash transfer and group counselling during the last 12 months. In a subsample of communes from the experimental group, villages were randomized to either receive Preventive Nutrition Packages (PNP) or nothing. The impact of PNP is analyzed by comparing villages that received PNP and villages that did not receive PNP during the last 12 months of the program.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control and comparison group -cash transfer program | Active comparator | Other: Cash distribution during the last 12 months, Behavioral: Accompanying information sessions on health, child nutrition, household economics and education during the last 12 monthsThe program is implemented during 48 months. During the first 36 months the control group does not receive any intervention. During the last 12 months eligible beneficiaries receive cash transfer and accompanying information sessions on health, child nutrition, household economics every three months (identical to experimental group). |
| Jigisemejiri cash transfer program | Experimental | Other: Cash distribution during first 36 months, Behavioral: Accompanying information sessions on health, child nutrition, household economics and education during first 36 monthsUnconditional cash is distributed every 3 months to beneficiaries of the Jigisemejiri program. During cash handouts, information sessions on health, child nutrition, households economics and education are organized by local NGOs. |
| Jigisemejiri - Preventive Nutrition packages | Experimental | Other: Cash distribution during first 36 months, Behavioral: Accompanying information sessions on health, child nutrition, household economics and education during first 36 months, Dietary Supplement: Preventive Nutrition Packages during last 12 monthsHouseholds belonging to the experimental group who previously received Cash transfer and information sessions on health, child nutrition, households economics and education for 36 months, with children and/or pregnant/lactating women receiving rations of fortified flour (PNP) during the last 12 months of the project |
| Control and comparison group - Preventive Nutrition packages | Active comparator | Other: Cash distribution during first 36 months, Behavioral: Accompanying information sessions on health, child nutrition, household economics and education during first 36 monthsHouseholds belonging to the experimental group who previously received Cash transfer and information sessions on health, child nutrition, households economics and education for 36 months, with children and/or pregnant/lactating women |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Being a Household that is beneficiary of the Jigisemejiri program
- Having a child between 6 and 24 months of age
Key exclusion criteria (1 listed)
- Congenital malformations that hamper anthropometric measurements
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 |
|---|---|---|
| Cash distribution during first 36 monthsThree-monthly distribution of Cash (30,000 FCFA/trimester) to households that are beneficiary of the Jigisemejiri program. | Other | Control and comparison group - Preventive Nutrition packages, Jigisemejiri - Preventive Nutrition packages, Jigisemejiri cash transfer program |
| Accompanying information sessions on health, child nutrition, household economics and education during first 36 monthsLarge group gatherings of cash beneficiaries are organized in parallel to the cash distributions. During these meetings, local NGOs present and discuss a topic related to health, child nutrition, household economics or education. | Behavioural | Control and comparison group - Preventive Nutrition packages, Jigisemejiri - Preventive Nutrition packages, Jigisemejiri cash transfer program |
| Preventive Nutrition Packages during last 12 monthsFortified flour supplements for children (Supercereal Plus)and pregnant/lactating mothers (super Cereal) | Dietary supplement | Jigisemejiri - Preventive Nutrition packages |
| Cash distribution during the last 12 monthsThree-monthly distribution of Cash (30,000 FCFA/trimester) to households that are beneficiary of the Jigisemejiri program. | Other | Control and comparison group -cash transfer program |
| Accompanying information sessions on health, child nutrition, household economics and education during the last 12 monthsLarge group gatherings of cash beneficiaries are organized in parallel to the cash distributions. During these meetings, local NGOs present and discuss a topic related to health, child nutrition, household economics or education. | Behavioural | Control and comparison group -cash transfer program |
Primary outcome
Child Height-for-age Z-score
Time frame: After 24 months of program implementation
To calculate WHZ scores the 2006 WHO growth reference will be used
Value of household consumption
Time frame: After 24 months of program implementation
The household consumption includes food and non-food related economic consumption
Household dietary diversity
Time frame: After 24 months of program implementation
The household dietary diversity is estimated by a dietary diversity score counting food groups
Child Height-for-age Z-score
Time frame: After 48 months of program implementation (only in cross-sectional survey)
To calculate HAZ scores the 2006 WHO growth reference will be used (only in cross-sectional survey)
Value of household consumption
Time frame: After 48 months of program implementation
The household consumption includes food and non-food related economic consumption
Household dietary diversity
Time frame: After 48 months of program implementation
The household dietary diversity is estimated by a dietary diversity score counting food groups
Child Weight-for-Height Z-score
Time frame: After 48 months of program implementation (only in cross-sectional survey)
To calculate WHZ scores the 2006 WHO growth reference will be used (only in cross-sectional survey)
22 secondary outcomes
Child Weight-for-height Z-score
Time frame: After 24 months of program implementation
Prevalence of child wasting
Time frame: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Prevalence of child stunting
Time frame: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Child hemoglobin concentration
Time frame: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Prevalence of child anemia
Time frame: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Body Mass Index of primary caregiver of index child
Time frame: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Early child development
Time frame: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Child morbidity (acute respiratory infections, fever, vomiting, diarrhea)
Time frame: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Caregiver's knowledge and practices related to Infant and Young Child Feeding (IYCF), child health and hygiene
Time frame: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Household assets and savings
Time frame: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Educational level of Household members
Time frame: After 24 months and 48 months of program implementation
Household food security
Time frame: After 24 months and 48 months of program implementation
Household composition
Time frame: After 24 months and 48 months of program implementation
Household agricultural production
Time frame: After 24 months and 48 months of program implementation
Cognitive function of the head of household
Time frame: After 24 months of program implementation
Well-being of household members
Time frame: After 24 months and 48 months of program implementation
Women's empowerment
Time frame: After 24 months and 48 months of program implementation
Child dietary diversity
Time frame: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Professional occupation of household members
Time frame: After 24 months and 48 months of program implementation
Child Mid-upper Arm Circumference
Time frame: After 24 months and 48 months (only in cross-sectional survey) of program implementation
Maternal hemoglobin concentration
Time frame: After 48 months (only in cross-sectional survey) of program implementation
Maternal anemia
Time frame: After 48 months (only in cross-sectional survey) of program implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Dan Gilligan, PhD study chair
IFPRI
Marie Ruel, PhD study chair
IFPRI
Melissa Hidrobo, PhD principal investigator
IFPRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cash distribution during first 36 months, Accompanying information sessions on health, child nutrition, household economics and education during first 36 months and Preventive Nutrition Packages during last 12 months in people with Poverty and Child Malnutrition, run by International Food Policy Research Institute at 1 site in Mali.
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 2 inclusion and 1 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Child Height-for-age Z-score (time frame: After 24 months of program implementation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2019.