Clinical trial NCT04872088: Integrated Research on Acute Malnutrition in Mali (IRAM-MALI)
Official title: Impact Evaluation of Integrated Interventions to Reduce Child Wasting in Mali
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Malnutrition in Childhood
Wasting
Lead sponsor: International Food Policy Research Institute
Sponsor class: OTHER
Collaborators: name: UNICEF
name: World Vision
name: AFRICSante
First posted: 2021-05-04
Enrollment: 9797
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-blinded cluster randomized controlled trial
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: The longitudinal prevalence of wasting in children enrolled at the age of 6 months followed monthly until the end of the study (Cohort 1).
timeFrame: 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
measure: 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)
timeFrame: 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
measure: Prevalence of relapse after discharge from CMAM treatment (cohort 3).
timeFrame: Up to 4 months, at three months after discharge from CMAM treatment
Secondary outcomes:
measure: Longitudinal prevalence of MAM (cohort 1)
timeFrame: 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
measure: Longitudinal prevalence of SAM (cohort 1)
timeFrame: 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
measure: Incidence of Wasting, MAM and SAM (cohort 1)
timeFrame: 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
measure: Hemoglobin concentration of children (cohort 1)
timeFrame: Up to 7 months, from date of enrolment until the date of last documented progressio
measure: Prevalence of anaemia (cohort 1)
timeFrame: Up to 7 months, from date of enrolment until the date of last documented progressio
measure: Child weight (cohort 1)
timeFrame: 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
measure: Child length (cohort 1)
timeFrame: 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
measure: Length-for-age Z-score (cohort 1)
timeFrame: 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
measure: Prevalence of child stunting (cohort 1)
timeFrame: 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
measure: Longitudinal wasting screening coverage (cohort 1)
timeFrame: 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
measure: Referral rate of positive screenings (cohort 1)
timeFrame: 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
measure: Early Child development (cohort 1)
timeFrame: 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
measure: Linear growth rate (cohort 1)
timeFrame: 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
measure: Ponderal growth rate (cohort 1)
timeFrame: 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
measure: MUAC growth rate (cohort 1)
timeFrame: 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
measure: Longitudinal prevalence of child morbidity (cohort 1)
timeFrame: 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
measure: Parental knowledge of nutrition, WASH, and health best practices (cohort 1)
timeFrame: 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
measure: Longitudinal prevalence of Introduction of (semi) solid and soft complementary foods (cohort 1)
timeFrame: 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
measure: Longitudinal prevalence of minimum dietary diversity of infant and young children (cohort 1)
timeFrame: 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
measure: Longitudinal prevalence of infant and young child minimum meal frequency (cohort 1)
timeFrame: 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
measure: Longitudinal prevalence of infant and young child minimum acceptable diet (cohort 1)
timeFrame: 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
measure: Longitudinal prevalence of continuous breastfeeding (cohort 1)
timeFrame: 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
measure: Longitudinal prevalence of infant and young child consumption of iron-rich or iron-fortified foods (cohort 1)
timeFrame: 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
measure: Vaccination coverage (cohort 1)
timeFrame: 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
measure: Adoption of practices recommended by NASGs (cohort 1)
timeFrame: 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
measure: Weight-for-length Z-score and MUAC at enrollment in CMAM (cohort 2)
timeFrame: Up to 7 months, at the date of inclusion in CMAM program
measure: Duration of CMAM treatment (cohort 2)
timeFrame: 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
measure: Treatment adherence (cohort 2)
timeFrame: 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
measure: Treatment outcomes (drop-out, death, transfer, non-response rates) (cohort 2)
timeFrame: 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 firs
measure: Longitudinal prevalence of childhood morbidity (cohort 2)
timeFrame: 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
measure: Mid-Upper Arm Circumference of children (cohort 3)
timeFrame: Up to 4 months, at three months after discharge from CMAM treatment
measure: Child weight (cohort 3)
timeFrame: Up to 4 months, at three months after discharge from CMAM treatment
measure: Child length(cohort 3)
timeFrame: Up to 4 months, at three months after discharge from CMAM treatment
measure: Weight-for-length Z-score (cohort 3)
timeFrame: Up to 4 months, at three months after discharge from CMAM treatment
measure: Length-for-age Z-score (cohort 3)
timeFrame: Up to 4 months, at three months after discharge from CMAM treatment
measure: Child Stunting (cohort 3)
timeFrame: Up to 4 months, at three months after discharge from CMAM treatment
measure: Wasting screening coverage (cohort 3)
timeFrame: Up to 4 months, at three months after discharge from CMAM treatment
measure: Prevalence of readmission (cohort 3)
timeFrame: Up to 4 months, at three months after discharge from CMAM treatment
measure: Prevalence of anemia (cohort 3)
timeFrame: Up to 4 months, at three months after discharge from CMAM treatment
measure: Hemoglobin concentration of children (cohort 3)
timeFrame: Up to 4 months, at three months after discharge from CMAM treatment
measure: Longitudinal prevalence of childhood morbidity (cohort 3)
timeFrame: Up to 4 months, at three months after discharge from CMAM treatment
measure: Prevalence of minimum dietary diversity of infant and young children (cohort 3)
timeFrame: Up to 4 months, at three months after discharge from CMAM treatment
measure: Prevalence of infant and young child minimum meal frequency (cohort 3)
timeFrame: Up to 4 months, at three months after discharge from CMAM treatment
measure: Prevalence of infant and young child minimum acceptable diet (cohort 3)
timeFrame: Up to 4 months, at three months after discharge from CMAM treatment
measure: Prevalence of infant and young child consumption of iron-rich or iron-fortified foods (cohort 3)
timeFrame: Up to 4 months, at three months after discharge from CMAM treatment
measure: Prevalence of continuous breastfeeding (cohort 1)
timeFrame: Up to 4 months, at three months after discharge from CMAM treatment
measure: Adoption of practices recommended by NASGs (cohort 3)
timeFrame: Up to 4 months, at three months after discharge from CMAM treatment
Other outcomes:
Locations:
city: Sikasso
country: Mali
facility: Koutiala Health District
Study officials:
affiliation: IFPRI
name: Lieven Huybregts, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: IFPRI
name: Elodie Becquey, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: IFPRI
name: Jef Leroy
role: PRINCIPAL_INVESTIGATOR
References: