Effectiveness of Positive Deviance/Hearth in Treating Uncomplicated Moderate Acute Malnutrition i… (NCT07591064) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effectiveness of Positive Deviance/Hearth in Treating Uncomplicated Moderate Acute Malnutrition in Children 6-59 Months in Mymensingh Division, Bangladesh
Bangladesh400 participantsStarted 2026-05-16
Plain-language summary
The goal of this clinical trial (cluster randomized controlled trial) is to learn whether a Positive Deviance/Hearth (PDH) intervention can effectively treat moderate acute malnutrition (MAM) and reduce relapse compared to standard care in children aged 6-59 months diagnosed with MAM in Bangladesh. The main questions it aims to answer are:
* Does the PDH intervention improve recovery rates among children with MAM?
* Does the PDH intervention reduce relapse to MAM or progression to severe acute malnutrition (SAM) after recovery?
Researchers will compare communities receiving the PDH intervention to communities receiving standard nutrition care (e.g., usual counseling or supplementary feeding programs) to see if PDH leads to better nutritional recovery and sustained outcomes.
Participants will:
* Take part in a 12-day "Hearth" nutrition education program where caregivers prepare and feed children nutrient-dense meals using local foods
* Receive 2 weeks of home follow-up visits by volunteers after the Hearth sessions, along with ongoing growth monitoring and counseling twice per month
* Undergo periodic anthropometric assessments (weight, height/length, Mid-upper arm circumference (MUAC)) at key time points
Who can participate
Age range
6 Months – 59 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.
Inclusion Criteria:
* Children 6-52.9 months at Baseline. This is so that children are 6-59 months by end of study (6-7 months from baseline)
* Children with MAM (WHZ/WLZ \<-2 and ≥-3 and/or MUAC \<125mm and ≥115mm)
* No Medical Complications (passes IMCI screening questions)
* No oedema
* Child does not deteriorate to SAM (WHZ/WLZ\<-3 and/or MUAC\<115mm) because child should be referred to health centre
* Caregiver refuses to receive age-appropriate immunization, Vitamin A and deworming minimum 2 weeks before PDH begins
* Child is not planning to live outside the study area routinely for more than 2 weeks during the 3 months of the study
* Written/Oral consent is given by Parent/Caregiver to participate in the study
Exclusion Criteria:
* Child is not between 6-52 months of age at Baseline
* Child does not meet the inclusion criteria for WHZ/WLZ and/or MUAC; (WHZ/WLZ \<-2SD and ≥-3SD and/or MUAC \<125mm and ≥115mm);
* Child has oedema;
* Child has medical complications and/or does not pass the IMCI screening including fever, nausea/vomiting, acute respiratory illness (refer to Study Protocol V2.0, 19 Feb 2026);
* Deteriorates to SAM and must be removed from the study and referred to the health centre for specially formulated food (SFF) treatment;
* Refuses to receive minimum 2 weeks before the intervention begins, age-appropriate immunization and Vitamin A and deworming in the past 6 months;
* Child lives outside the study area routinely or will be outside of the study are…
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
Rehabilitation of MAM (Primary)
Timeframe: From enrollment to end of treatment at 3 months