Integrated Research on Acute Malnutrition in Mali (IRAM-MALI)

International Food Policy Research Institute

Status: Completed

Conditions: Acute Malnutrition in Childhood; Wasting

Treatments: Behavioral: Cooking demonstrations; Behavioral: Intensified followup of children with wasting referred to and enrolled in CMAM treatment; Behavioral: Active screening by NASGs; Dietary Supplement: Preventive nutritional supplement; Behavioral: Family MUAC; Behavioral: Strengthened SBCC; Behavioral: Relapse prevention

Study type: Interventional

Funder types: Other

Identifiers

NCT04872088

IRAM-MALI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9,797 patients

Sex: All

Ages: 6 to 23 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Cohort 1 (prevention cohort):

Inclusion criteria are:

• 6-6.9 months of age
• Singleton
• The mother must live in the study area from the time of inclusion.
• The consent of the mother or guardian

Exclusion criteria are :

• Congenital malformations that make anthropometric measurements impossible.
• Mother intends to leave the study area before January 2022.

Cohort 2 (treatment cohort):

Inclusion criteria are :

• The child is enrolled in CMAM treatment program.
• The child is between 6 and 23 months of age at inclusion
• Child lives in one of the 45 health center catchment areas in the study area

Cohort 3 (relapse cohort):

Inclusion criteria are:

• Child has been successfully treated for wasting and MAM and has been discharged from CMAM treatment program for at least three months
• The child is between 9 and 17 months at time of measurement.
• The child is singleton.
• The mother must live in the study area from the time of inclusion.
• The consent of the mother or guardian

Exclusion criteria are :

• Congenital malformations that make anthropometric measurements impossible.
• Mother intends to leave the study area before January 2022.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9,797 participants in 2 patient groups

Control

No Intervention group

Description:

The control group will receive preventive (BCC on child health and nutrition) and screening services from existing unsupervised Nutrition Activity Support Groups (NASGs) without additional support from the IRAM project. Children with wasting are eligible to be enrolled in the existing national Community Management of Acute Malnutrition (CMAM) program.

Intervention

Experimental group

Description:

The intervention group will receive the integrated package of interventions that will be delivered by the NASGs. The NASG platform will be strengthened by the IRAM project by increasing their number proportional to the size of the population of the catchment area they serve and by regular formative supervision by NGO and health center staff. The package of interventions includes: * Social and Behavioral Change Communication by NASGs during home visits and group sessions * Monthly delivery of preventive SQ-LNS to children 6-17 months of age * Screening and referral of children 6-59 months of age through the introduction of the MUAC family approach (distribution MUAC tapes to families and offering formative supervision by NASGs to enhance measurement quality) * Cooking demonstrations for complementary foods using nutrientdense foods in the community.

Treatment:

Behavioral: Family MUAC

Behavioral: Intensified followup of children with wasting referred to and enrolled in CMAM treatment

Behavioral: Relapse prevention

Behavioral: Strengthened SBCC

Behavioral: Active screening by NASGs

Dietary Supplement: Preventive nutritional supplement

Behavioral: Cooking demonstrations