Integrated Research on Acute Malnutrition in Mali (IRAM-MALI)
Condition: Acute Malnutrition in Childhood; Wasting
MeSH terms: Malnutrition; Wasting Syndrome; Cachexia
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Strengthened SBCC; Preventive nutritional supplement; Family MUAC; Active screening by NASGs; Intensified followup of children with wasting referred to and enrolled in CMAM treatment; Relapse prevention; Cooking demonstrations
Intervention type(s): Behavioral; Dietary Supplement; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Social and Behavioral Change Communication related to prenatal, postnatal, IYCF practices as well as on the care of young children at several specific ages, hygiene, and health will be delivered during monthly home visits by pairs of NASG members.; Monthly delivery by NAGS pairs of a nutritional supplement: SQ-LNS, at a dose of 28 bags of 20g per month per beneficiary child. The nutritional supplement is limited to :
- [6-17]months old children diagnosed as non-wasted (MUAC>=125mm); MUAC screening of children 6 to 59 months of age by family members will be introduced. This will involve distributing Shakir MUAC tapes to all intervention households and training mothers/guardians, or any other family member expressing an interest, in the screening of wasting with the MUAC criterion.
The training will be carried out by the members of the NASGs and during each home visit, they will be able to ensure that the MUAC measurement technique is well mastered by the mother (or another member) and correct the technique if necessary. They will also explain the procedure to be followed if the child is diagnosed as wasted by a family.; Monthly screening by the NASG members of the children they follow, using the MUAC.
Referral to the health center of [6-17] months old children screened as malnourished (result of MUAC orange or red), and follow-up on referral to confirm child was enrolled.; NASG members will conduct biweekly follow-up visits in the households of children with wasting referred to and enrolled in CMAM treatment programs to ensure adherence to the outpatient treatment schedule.; NASG members will conduct biweekly home visits to monitor the nutritional status of children aged 9 to 17 months who were discharged from CMAM treatment after recovery. NASGs members will provide additional counseling to prevent relapse and screen these children for wasting to detect possible relapse.; NASGs members will also be supported by the IRAM project in the organization of cooking demonstrations with nutrient-rich foods in the community, during which passive screening of children will be carried out.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Non-blinded cluster randomized controlled trial
Masking: None (Open Label)
Primary purpose: Other