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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02858011
Other study ID # 2014-26-PHND-M
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2014
Est. completion date August 10, 2019

Study information

Verified date September 2019
Source International Food Policy Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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

1. 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.

2. 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.

3. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4320
Est. completion date August 10, 2019
Est. primary completion date August 10, 2019
Accepts healthy volunteers No
Gender All
Age group 6 Months to 5 Years
Eligibility Inclusion Criteria:

- Being a Household that is beneficiary of the Jigisemejiri program

- Having a child between 6 and 24 months of age

Exclusion Criteria:

- Congenital malformations that hamper anthropometric measurements

Study Design


Intervention

Other:
Cash distribution during first 36 months
Three-monthly distribution of Cash (30,000 FCFA/trimester) to households that are beneficiary of the Jigisemejiri program.
Behavioral:
Accompanying information sessions on health, child nutrition, household economics and education during first 36 months
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.
Dietary Supplement:
Preventive Nutrition Packages during last 12 months
Fortified flour supplements for children (Supercereal Plus)and pregnant/lactating mothers (super Cereal)
Other:
Cash distribution during the last 12 months
Three-monthly distribution of Cash (30,000 FCFA/trimester) to households that are beneficiary of the Jigisemejiri program.
Behavioral:
Accompanying information sessions on health, child nutrition, household economics and education during the last 12 months
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
International Food Policy Research Institute Implementation management committee of the Jigisemejiri program (Ministry of Economics and Finance, Government of Mali), Institut de Recherche pour le Developpement

Country where clinical trial is conducted

Mali, 

Outcome

Type Measure Description Time frame Safety issue
Primary Child Height-for-age Z-score To calculate WHZ scores the 2006 WHO growth reference will be used After 24 months of program implementation
Primary Value of household consumption The household consumption includes food and non-food related economic consumption After 24 months of program implementation
Primary Household dietary diversity The household dietary diversity is estimated by a dietary diversity score counting food groups After 24 months of program implementation
Primary Child Height-for-age Z-score To calculate HAZ scores the 2006 WHO growth reference will be used (only in cross-sectional survey) After 48 months of program implementation (only in cross-sectional survey)
Primary Value of household consumption The household consumption includes food and non-food related economic consumption After 48 months of program implementation
Primary Household dietary diversity The household dietary diversity is estimated by a dietary diversity score counting food groups After 48 months of program implementation
Primary Child Weight-for-Height Z-score To calculate WHZ scores the 2006 WHO growth reference will be used (only in cross-sectional survey) After 48 months of program implementation (only in cross-sectional survey)
Secondary Child Weight-for-height Z-score To calculate WHZ scores the 2006 WHO growth reference will be used After 24 months of program implementation
Secondary Prevalence of child wasting To calculate WHZ scores the 2006 WHO growth reference will be used After 24 months and 48 months (only in cross-sectional survey) of program implementation
Secondary Prevalence of child stunting To calculate WHZ scores the 2006 WHO growth reference will be used After 24 months and 48 months (only in cross-sectional survey) of program implementation
Secondary Child hemoglobin concentration After 24 months and 48 months (only in cross-sectional survey) of program implementation
Secondary Prevalence of child anemia After 24 months and 48 months (only in cross-sectional survey) of program implementation
Secondary Body Mass Index of primary caregiver of index child After 24 months and 48 months (only in cross-sectional survey) of program implementation
Secondary Early child development After 24 months and 48 months (only in cross-sectional survey) of program implementation
Secondary Child morbidity (acute respiratory infections, fever, vomiting, diarrhea) After 24 months and 48 months (only in cross-sectional survey) of program implementation
Secondary Caregiver's knowledge and practices related to Infant and Young Child Feeding (IYCF), child health and hygiene After 24 months and 48 months (only in cross-sectional survey) of program implementation
Secondary Household assets and savings After 24 months and 48 months (only in cross-sectional survey) of program implementation
Secondary Educational level of Household members After 24 months and 48 months of program implementation
Secondary Household food security Measured by the Household Food Insecurity Access Scale (HFIAS) After 24 months and 48 months of program implementation
Secondary Household composition This entails the household size, the number of one parent households, monogamous and polygamous households, number of infants and children. After 24 months and 48 months of program implementation
Secondary Household agricultural production The composition and quantity of all crops grown by the houshold over the last year is being recalled After 24 months and 48 months of program implementation
Secondary Cognitive function of the head of household Measured by spatial Stroop test and digit span test (forward and backward) After 24 months of program implementation
Secondary 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. After 24 months and 48 months of program implementation
Secondary Women's empowerment Measured by pro-WEAI instrument adapted to local context After 24 months and 48 months of program implementation
Secondary Child dietary diversity Child dietary diversity is estimated by a dietary diversity score counting food groups consumed After 24 months and 48 months (only in cross-sectional survey) of program implementation
Secondary 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 After 24 months and 48 months of program implementation
Secondary Child Mid-upper Arm Circumference After 24 months and 48 months (only in cross-sectional survey) of program implementation
Secondary Maternal hemoglobin concentration After 48 months (only in cross-sectional survey) of program implementation
Secondary Maternal anemia After 48 months (only in cross-sectional survey) of program implementation
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