Clinical Trials Logo

Clinical Trial Summary

The IRAM MALI impact evaluation uses a cluster-randomized controlled study design to assess the impact of the package of integrated interventions aimed at reducing the longitudinal prevalence of wasting by reducing the incidence of child wasting, enhancing the recovery/cure rate from wasting treatment and reducing the relapse rate determined three months after post-treatment recovery from wasting. These interventions include, among other things, strengthening of community care groups (NASGs); home visits with delivery of behavioral change communication about nutrition, health and hygiene (WASH) for young children; distribution of a preventive nutritional supplement; and improved coverage of wasting screening (family MUAC and community screening), management, adherence to treatment and prevention of relapse in the health district of Koutiala, Sikasso region, Mali, West Africa.


Clinical Trial Description

Progress in reducing the burden of child wasting is hampered by several factors. First, programmatic evidence on how to prevent wasting is limited. There is a growing body of evidence on the effectiveness of dietary supplements in preventing wasting, but little is known about the effectiveness of other strategies such as behavior change communication (BCC) (with or without supplements), cash transfers, or water, hygiene, and sanitation (WASH) interventions. Second, coverage of CMAM (Community based Management of Acute Malnutrition) treatment remains low in many settings. On the supply side, documented constraints include the complexity of current treatment procedures, which disproportionately affects resource-limited settings, and frequent shortages of treatment commodities. On the demand side, low participation in screening and low treatment uptake and adherence are key constraints to effective treatment. Reducing the burden of wasting effectively requires coordination and integration of sequenced interventions and services along the continuum of care of child wasting including prevention, screening of cases, the timely and adequate treatment of wasted children, and the prevention of relapse of recovered children. The overall objective of the study is to assess the impact of an integrated package covering the continuum of care of wasting on the longitudinal prevalence of child wasting. The implementation of these interventions is led by World Vision Mali in collaboration with the health services of the Koutiala health district (Sikasso region, Mali) and UNICEF, and will take place at health center and community level, and includes i) a prevention component combining the strengthening of Nutrition Activity Support Groups (NASG) (who will conduct monthly home visits to deliver behavioral change communication, group counselling sessions and cooking demonstrations) and the distribution of Small-Quantity Lipid-based Nutrient Supplements (SQ-LNS) to children over 6 months of age; ii) a component related to strengthening screening and referral that will involve families (MUAC family approach) and screening by NASGs; iii) a treatment component that includes strengthening the national CMAM protocol currently in vigor in Mali and intensive follow-up of cases under treatment by NASGs to enhance adherence to treatment; and iv) a targetted prevention component through intensified follow-up visits by NASGs and the distribution of SQ-LNS to children who recovered from wasting. The study, designed as a randomized controlled clustered trial, will allocate 45 health center catchment areas to an intervention (n=22) and comparison group (n=23) and will assess the impact of the integrated package of interventions in three different cohort samples - the longitudinal prevalence of wasting in children between 6 and 14 months of age (cohort 1; n=1,620) - the recovery rate of children 6-23 months of age enrolled in wasting, MAM and SAM treatment (cohort 2; census of all children enrolled in treatment programs between May and December 2021) - the incidence of relapse in children aged 9-17 months discharged from wasting, MAM and SAM treatment after recovery (cohort 3; n=945), determined 3 months post-treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04872088
Study type Interventional
Source International Food Policy Research Institute
Contact
Status Completed
Phase N/A
Start date May 6, 2021
Completion date October 15, 2022

See also
  Status Clinical Trial Phase
Terminated NCT05543759 - Simplified Treatment Protocol for Acute Malnutrition in Venezuela
Completed NCT01562379 - Complementary Food Supplements for Reducing Childhood Undernutrition Phase 2/Phase 3
Not yet recruiting NCT05517395 - The Effectiveness of HBM-based Education Program on Improve Knowledge and Behaviors N/A
Completed NCT04561635 - Effects of Multiple-micronutrients Supplementation on Growth and Iron Status of Indigenous Children in Malaysia N/A
Active, not recruiting NCT03509155 - Food Supplement Treatment for Wasting Children in Indonesia N/A
Completed NCT03847662 - Scaling up Small-Scale Food Processing to Promote Food Security Among Women Farmers in Rural Vietnam
Completed NCT01920724 - Body Composition in Preschool Children
Active, not recruiting NCT02441426 - Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development N/A
Completed NCT05322655 - PAthogen Transmission and Health Outcome Models of Enteric Disease
Terminated NCT04233944 - Uganda Birth Cohort Study
Completed NCT04867694 - Integrated Research on Acute Malnutrition in Chad N/A
Completed NCT05891457 - Changes in Nerve Electro Physiologic Properties in Children Before and After Correction of Malnutrition N/A
Recruiting NCT05519254 - Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae Phase 3
Recruiting NCT06018636 - Impact of Diet and Nutrition on Growth and Development in Young Children
Completed NCT04587271 - Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children N/A
Completed NCT02638571 - Evaluation Nutrition Education Intervention on Pulse and Cereal Mix for Complementary Food in Southern Ethiopia N/A
Completed NCT04704076 - Preventing Infant Malnutrition With Early Supplementation N/A
Completed NCT01898871 - Effectiveness of Nutritional Products to Treat Moderate Acute Malnutrition Phase 2
Recruiting NCT05793294 - Child Health, Nutrition and Gut Microbiome Development
Recruiting NCT06287827 - Treatment of Acute Malnutrition in Outpatient Care Services in Venezuela: a Prospective Cohort Research