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

Not Applicable

Completed

Conditions: Acute Malnutrition in Childhood
Wasting

Interventions: 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

Registration Number: NCT04872088

Lead Sponsor: International Food Policy Research Institute

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 9797

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Family MUAC	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.
Intervention	Relapse prevention	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.
Intervention	Strengthened SBCC	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.
Intervention	Preventive nutritional supplement	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.
Intervention	Active screening by NASGs	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.
Intervention	Intensified followup of children with wasting referred to and enrolled in CMAM treatment	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.
Intervention	Cooking demonstrations	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.

Primary Outcome Measures

Name	Time	Method
Prevalence of relapse after discharge from CMAM treatment (cohort 3).	Up to 4 months, at three months after discharge from CMAM treatment	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
The longitudinal prevalence of wasting in children enrolled at the age of 6 months followed monthly until the end of the study (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	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).
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)	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	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.

Secondary Outcome Measures

Name	Time	Method
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	defined as the number of months with MAM diagnosis divided by the total number of monthly visits made by the survey teams.
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	defined by the number of months with SAM diagnosis divided by the total number of monthly visits made.
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	defined as the number of new cases of wasting, MAM and SAM diagnosed during the monthly visits made by the survey teams.
Hemoglobin concentration of children (cohort 1)	Up to 7 months, from date of enrolment until the date of last documented progressio	measured by hemocue reader (model 301)
Prevalence of anaemia (cohort 1)	Up to 7 months, from date of enrolment until the date of last documented progressio	defined as the proportion of children with a hemoglobin level below 11g/dl at the end of the study
Child weight (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	Child weight measured by survey teams
Child length (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	Child length measured by survey teams
Length-for-age Z-score (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	Length-for-age Z-score relative to the 2006 WHO reference
Prevalence of child stunting (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	Proportion of children with Length-for-age Z-score (LAZ)\<-2 (according to the 2006 WHO reference) at the end of the study
Longitudinal wasting screening coverage (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	defined as the proportion of children screened (using MUAC, WLZ or bilateral edema) in the month prior to the monthly visit by the interviewers. Two sub-outcomes will also be concerned: * Coverage of screening performed by NASGs in the past month. * Coverage of the family MUAC component, which is the screening performed by a family member in the past month.
Referral rate of positive screenings (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	defined as the proportion of children tested positive during the month (as reported by the mother) who were referred to the health center or Community health worker's site for treatment.
Early Child development (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	assessed via the Development Milestones Checklist-III score at the end of the study.
Linear growth rate (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	* The change in length per month * The change in the LAZ per month
Longitudinal prevalence of child morbidity (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	defined by the number of days with symptoms of acute respiratory infections, fever, diarrhea (three or more loose or liquid stools per day) and malaria divided by the total number of days observed/reported in the recall period
Parental knowledge of nutrition, WASH, and health best practices (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	expressed as cumulative total and domain-specific scores
Longitudinal prevalence of Introduction of (semi) solid and soft complementary foods (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	the proportion of children 6-8 months of age who consumed (semi) solid and soft complementary foods the day before the survey
Ponderal growth rate (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	* Weight change per month * The change in the WLZ per month
MUAC growth rate (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	change in MUAC per month * Weight change per month * The change in the WLZ index per month * MUAC gain (change in MUAC per month)
Longitudinal prevalence of infant and young child minimum meal frequency (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	defined as the proportion of children who had eaten the day before the survey: 2 meals for breastfed children 6-8 months, 3 meals for breastfed children 9-23 months, or 4 meals for non-breastfed children 6-23 monthsMinimum meal frequency for children, defined as the proportion of children who had eaten the day before the survey: 2 meals for breastfed children 6-8 months, 3 meals for breastfed children 9-23 months, or 4 meals for non-breastfed children 6-23 months. Minimum acceptable diet, defined as the proportion of children with both minimal dietary diversity and minimal meal frequency on the day before the survey. Consumption of iron-rich or iron-fortified foods in children.
Longitudinal prevalence of continuous breastfeeding (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	defined as the proportion of children breastfed during the study
Child length(cohort 3)	Up to 4 months, at three months after discharge from CMAM treatment	Length measured by survey teams
Longitudinal prevalence of minimum dietary diversity of infant and young children (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	The proportion of children who consumed at least 5 of the 8 food groups (including breast milk) the day before the survey.
Longitudinal prevalence of infant and young child minimum acceptable diet (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	defined as the proportion of children with both minimal dietary diversity and minimal meal frequency on the day before the survey.
Longitudinal prevalence of infant and young child consumption of iron-rich or iron-fortified foods (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	defined as the proportion of children who consumed flesh foods or iron-fortied foods the day before the survey
Vaccination coverage (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	Proportion of children with complete vaccination for their age
Prevalence of anemia (cohort 3)	Up to 4 months, at three months after discharge from CMAM treatment	defined as the proportion of children with a hemoglobin level below 11g/dl
Prevalence of infant and young child minimum acceptable diet (cohort 3)	Up to 4 months, at three months after discharge from CMAM treatment	defined as the proportion of children with both minimal dietary diversity and minimal meal frequency on the day before the survey.
Prevalence of infant and young child consumption of iron-rich or iron-fortified foods (cohort 3)	Up to 4 months, at three months after discharge from CMAM treatment	defined as the proportion of children who consumed flesh foods or iron-fortied foods the day before the survey
Adoption of practices recommended by NASGs (cohort 3)	Up to 4 months, at three months after discharge from CMAM treatment	related to WASH, treated net use, family planning, deworming, vitamin A, childbirth registration, use of iodized salt, and consumption of SQ-LNS
Weight-for-length Z-score and MUAC at enrollment in CMAM (cohort 2)	Up to 7 months, at the date of inclusion in CMAM program	weight-for-length Z-score (relative to the 2006 WHO reference) and MUAC(mm)
Adoption of practices recommended by NASGs (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	related to WASH, treated net use, family planning, deworming, vitamin A, childbirth registration, use of iodized salt, and consumption of SQ-LNS
Longitudinal prevalence of childhood morbidity (cohort 2)	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	defined by the number of days with symptoms of acute respiratory infections, fever, diarrhea (three or more loose or liquid stools per day) and malaria divided by the total number of days observed/reported in the recall period
Mid-Upper Arm Circumference of children (cohort 3)	Up to 4 months, at three months after discharge from CMAM treatment	measured using Shakir MUAC tape by survey teams
Prevalence of readmission (cohort 3)	Up to 4 months, at three months after discharge from CMAM treatment	Prevalence of children readmitted to CMAM treatment within three months after discharge from CMAM treatment from MAS and MAM treatment programs.
Longitudinal prevalence of childhood morbidity (cohort 3)	Up to 4 months, at three months after discharge from CMAM treatment	defined by the number of days with symptoms of acute respiratory infections, fever, diarrhea (three or more loose or liquid stools per day) and malaria divided by the total number of days observed/reported in the recall period
Duration of CMAM treatment (cohort 2)	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	defined as the number of days spent on treatment (enrollment and discharge) in children 6-23 months of age at enrollment, according to health registers
Treatment adherence (cohort 2)	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	defined as the proportion of cases enrolled for treatment who received timely treatment from dedicated services (health center or Community Health Worker) until recovery
Treatment outcomes (drop-out, death, transfer, non-response rates) (cohort 2)	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	Among cases of wasting, MAM and SAM enrolledin CMAM treatment
Child weight (cohort 3)	Up to 4 months, at three months after discharge from CMAM treatment	Weight measured by survey teams
Weight-for-length Z-score (cohort 3)	Up to 4 months, at three months after discharge from CMAM treatment	Weight-for-length Z-score relative to the 2006 WHO reference
Length-for-age Z-score (cohort 3)	Up to 4 months, at three months after discharge from CMAM treatment	Length-for-age Z-score relative to the 2006 WHO reference
Child Stunting (cohort 3)	Up to 4 months, at three months after discharge from CMAM treatment	defined as the proportion of children with Length-for-age Z-score \<-2 (relative to the 2006 WHO reference)
Wasting screening coverage (cohort 3)	Up to 4 months, at three months after discharge from CMAM treatment	defined as the proportion of children screened (using MUAC, WLZ-score or bilateral edema) in the month prior to the interviewer's visit. Two sub-outcomes will also be concerned: * Coverage of screening performed by NASGs in past month. * Coverage of the MUAC family component, which is the screening performed by a family member in past month.
Prevalence of minimum dietary diversity of infant and young children (cohort 3)	Up to 4 months, at three months after discharge from CMAM treatment	The proportion of children who consumed at least 5 of the 8 food groups (including breast milk) the day before the survey.
Hemoglobin concentration of children (cohort 3)	Up to 4 months, at three months after discharge from CMAM treatment	measured by hemocue reader (model 301) by survey teams
Prevalence of infant and young child minimum meal frequency (cohort 3)	Up to 4 months, at three months after discharge from CMAM treatment	defined as the proportion of children who had eaten the day before the survey: 2 meals for breastfed children 6-8 months, 3 meals for breastfed children 9-23 months, or 4 meals for non-breastfed children 6-23 monthsMinimum meal frequency for children, defined as the proportion of children who had eaten the day before the survey: 2 meals for breastfed children 6-8 months, 3 meals for breastfed children 9-23 months, or 4 meals for non-breastfed children 6-23 months. Minimum acceptable diet, defined as the proportion of children with both minimal dietary diversity and minimal meal frequency on the day before the survey. Consumption of iron-rich or iron-fortified foods in children.
Prevalence of continuous breastfeeding (cohort 1)	Up to 4 months, at three months after discharge from CMAM treatment	defined as the proportion of children breastfed during the study

Trial Locations

Locations (1): Koutiala Health District
🇲🇱
Sikasso, Mali

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

Recruitment & Eligibility

Study & Design

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