Moderate Acute Malnutrition (MAM), Undernutrition, Wasting
Conditions
Keywords
Moderate acute malnutrition (MAM), Children, relapse, positive deviance/hearth
Brief 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
Interventions
OTHERPD/Hearth is a behavioral change program that teaches caregivers how to cook and feed their children. A nutrient-dense meal using local ingredients will be fed to children during Hearth sessions.
PD/Hearth is a behavior change program that uses practice by doing approach for caregivers with children 6-59 months and empowers them to treat moderate acute malnutrition (MAM) at home using low cost local ingredients readily available. This makes it a much more sustainable approach in treating MAM children than specialized formulated foods, dietary supplements, or other processed foods.
Children will receive basic health and nutrition services, including infant and young child feeding counselling.
Sponsors
World Vision US
London School of Hygiene and Tropical Medicine
International Centre for Diarrhoeal Disease Research, Bangladesh
World Vision
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The data collectors/enumerators will also be masked in addition to the investigator and data analyzers until analysis is complete.
Intervention model description
Cluster randomized control trial with two arms. One arm will receive standard of care and the second arm will receive a food-based intervention program called, "Positive Deviance/Hearth".
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
Yes
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 area for more than 2 weeks in the upcoming 3 months * Parent/Caregiver unable or unwilling to attend PDH from start; * Parent/Caregiver does not provide written or oral consent to screen for the trial; * Parent/Caregiver does not provide informed consent for the study; and * any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rehabilitation of MAM (Primary) | From enrollment to end of treatment at 3 months | Child will be considered rehabilitated when the child is no longer MAM, definition is: Weight-for-Height Z-score (WHZ)/Weight-for-Length Z-score (WLZ) ≥ -2.0 SD or Mid-Upper Arm Circumference (MUAC) ≥ 125 mm (based on admission criterion), and no bilateral pitting oedema. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight-for-age (WAZ) | At end of treatment at 3 months | Average WAZ |
| Average Mid-upper arm circumference (MUAC) | At the end of treatment at 3 months | Average MUAC (mm) |
| Non-response | Within 4 months of enrollment; 1 month after attending second round of Hearth | Children not achieving anthropometric recovery within 4 months of initiating treatment (2 rounds of Hearth and follow-up at 30 days after second round of Hearth). Recovery definition is: WHZ/WLZ ≥ -2.0 SD or MUAC ≥ 125 mm (based on admission criterion), and absence of bilateral pitting oedema. |
| Sustained Recovery | 6 months after receiving treatment | Child who met rehabilitation criteria at 3 months and sustained recovery for at least 6 months. Recovery definition is WHZ/WLZ ≥ -2.0 SD or MUAC ≥ 125 mm (based on admission criterion), and absence of bilateral pitting oedema. |
| Alternative Sustained Recovery Definition (including WAZ) | 6 months after receiving treatment. | Child recovered at 3 months but at 6 months has WHZ/WLZ \< -2.0 SD or MUAC \< 125 mm. Recovery definition is: WHZ/WLZ ≥ -2.0 SD or MUAC ≥ 125 mm (based on admission criterion), and absence of bilateral pitting oedema and WAZ≥-3.0 SD. |
| Average daily weight gain (g/kg/day) | From enrollment to end of treatment at 3 months | Average rate of weight gain of children during 3 month follow-up. Weight at 3 months subtracted by weight at baseline divided by number of days (90 days). |
| Recovery of MAM | From enrollment to end of treatment at 3 months | Child meets the following criteria: WHZ/WLZ ≥ -2.0 SD or MUAC ≥ 125 mm (based on admission), and WAZ ≥ -3.0 SD, and no bilateral pitting oedema will be considered "Recovered from MAM". |
Countries
Bangladesh
Contacts
CONTACTDiane Baik, PhD (c), MSc, HBSc
CONTACTBidhan Krishna Sarker, MSS
Outcome results
None listed