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

NCT04872088 | Completed

• 1 other identifier: IRAM-MALI
• Study Type: interventional
• Target: 9,797
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Malnutrition in Childhood; Wasting

Outcome Measures

Primary Outcomes (3)

• The longitudinal prevalence of wasting in children enrolled at the age of 6 months followed monthly until the end of the study (Cohort 1).

  This indicator is defined for each child as the number of visits during which nutritional wasting is observed divided by the total number of monthly visits made (by the interviewers).

  Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first

• Recovery rate in children enrolled at [6-23] months of age for up to 3 months of treatment and followed through to discharge (Cohort 2)

  This indicator is defined as the number children who recovered from wasting, MAM and SAM according to national program criteria (WHZ\>-2 and MUAC\>=125mm and absence of bilateral edema for two consecutive visits, within 12 weeks of enrollment in the CMAM program) divided by the total number of treatment results recorded.

  Up to 3 months, from date of inclusion in CMAM program until the date of recovery or 12th week after inclusion in CMAM program or date of death from any cause, whichever came first

• Prevalence of relapse after discharge from CMAM treatment (cohort 3).

  This indicator is defined as the proportion of children (9-17 months of age) with WLZ-score \<-2 or MUAC \<125 mm or bilateral edema three months after discharge from a CMAM wasting and moderate wasting treatment program

  Up to 4 months, at three months after discharge from CMAM treatment

Secondary Outcomes (47)

• Longitudinal prevalence of MAM (cohort 1)

  Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first

• Longitudinal prevalence of SAM (cohort 1)

  Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first

• Incidence of Wasting, MAM and SAM (cohort 1)

  Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first

• Hemoglobin concentration of children (cohort 1)

  Up to 7 months, from date of enrolment until the date of last documented progressio

• Prevalence of anaemia (cohort 1)

  Up to 7 months, from date of enrolment until the date of last documented progressio

Study Arms (2)

Control

NO INTERVENTION

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

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.

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

Interventions

Strengthened SBCC BEHAVIORAL

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.

Intervention

Preventive nutritional supplement DIETARY_SUPPLEMENT

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)

Intervention

Family MUAC BEHAVIORAL

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.

Intervention

Active screening by NASGs BEHAVIORAL

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.

Intervention

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

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.

Intervention

Relapse prevention BEHAVIORAL

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.

Intervention

Cooking demonstrations BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 6 Months - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• months of age
• Singleton
• The consent of the mother or guardian

You may not qualify if:

• Congenital malformations that make anthropometric measurements impossible.
• Mother intends to leave the study area before January 2022.
• Cohort 2 (treatment cohort):
• The child is enrolled in CMAM treatment program.
• Child lives in one of the 45 health center catchment areas in the study area
• Cohort 3 (relapse cohort):
• 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 consent of the mother or guardian
• Congenital malformations that make anthropometric measurements impossible.
• Mother intends to leave the study area before January 2022.

Sponsors & Collaborators

• International Food Policy Research Institute: lead
• UNICEF: collaborator
• World Vision: collaborator
• AFRICSante: collaborator

Study Sites (1)

Koutiala Health District

Sikasso, Mali

Location

MeSH Terms

Conditions

Cachexia

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Therapeutics; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Lieven Huybregts, PHD

  IFPRI

  PRINCIPAL INVESTIGATOR

• Elodie Becquey, PHD

  IFPRI

  PRINCIPAL INVESTIGATOR

• Jef Leroy

  IFPRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-blinded cluster randomized controlled trial

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: May 6, 2021
• Primary Completion: July 15, 2022
• Study Completion: October 15, 2022
• Last Updated: October 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At the time of publication of scientific articles presenting results, the fully anonymized databases will become a public good and will be made available to the scientific community, government, and partners.

Locations

MA (1)