Integrated Research on Acute Malnutrition in Mali (IRAM-MALI) (NCT04872088) | Clinical Trial Compass
CompletedNot Applicable
Integrated Research on Acute Malnutrition in Mali (IRAM-MALI)
Mali9,797 participantsStarted 2021-05-06
Plain-language 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.
Who can participate
Age range
6 Months – 23 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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
3
Prevalence of relapse after discharge from CMAM treatment (cohort 3).
Timeframe: Up to 4 months, at three months after discharge from CMAM treatment
Trial details
NCT IDNCT04872088
SponsorInternational Food Policy Research Institute