Effectiveness of Positive Deviance/Hearth in Treating Uncomplicated Moderate Acute Malnutrition in Children 6-59 Months in Mymensingh Division, Bangladesh

• PD/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. (Other): 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.
• Standard of Care (Investigator Selected) (Other): Children will receive basic health and nutrition services, including infant and young child feeding counselling.

Primary outcomes

• 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 outcomes

• 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".
• 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).
• 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.

Other outcomes

• Minimum Dietary Diversity (MDD) [From enrollment to end of treatment at 3 months.]: Child meets WHO MDD definition (fed 5 out of 8 food groups)
• Meal frequency [From enrollment to end of treatment at 3 months.]: Meets minimum meal frequency standard
• Minimum Acceptable Diet (MAD) [From enrollment to end of treatment at 3 months.]: Meets combined MDD + meal frequency
• Unhealthy Food Consumption [From enrollment to end of treatment at 3 months.]: Consumption of unhealthy foods/beverages; Yes to any of the questions of eating unhealth foods
• Child Illness Symptoms [From enrollment to end of treatment at 3 months.]: Presence of illness (e.g., diarrhea, fever, ARI)
• Care-seeking Behaviour [From enrollment to end of treatment at 3 months.]: Care sought for illness episode at health centre or hospital
• Handwashing practices [From enrollment to end of treatment at 3 months.]: Reporting of washing hands at all 5 critical time points.
• Caregiver psychological wellbeing [From enrollment to end of treatment at 3 months.]: 5 separate Caregiver Psychological Distress questions will be asked, following WHO-5 Well-Being Index to assess caregiver psychological wellbeing. Each question will have a scale 0 to 5, 0 being 'Never' and 5 being "All the time". The score for 5 questions will be totaled and if it is below 13, it indicates poor wellbeing and is an indication for depression under ICD-10. Caregivers with below a score of 13 will be referred for formal clinical services.
• Cost-effectiveness of PDH [From enrollment to six months.]: To assess the cost-effectiveness of PDH, taking into the costs of program design, implementation, and caregiver time.
• Change in WHZ/WLZ [From enrollment to end of treatment at 3 months]: Change in Weight-for-Height Z-score or Weight-for-Length z-score according to the WHO Growth Standards (Multicentre Growth Reference study measures).
• High vs. Low Risk MAM Recovery [From enrollment to end of treatment at 3 months]: Recovery stratified by risk group at enrollment. Definition of High Risk: MUAC 115-119 mm or WHZ -2.8 to -3.0 AND ≥1 contextual risk factor and Low Risk: MUAC >119 mm or WHZ >-2.8 AND no contextual risk factors.
• Change in WAZ [From enrollment to end of treatment at 3 months]: Change in Weight-for-age z-score according to the WHO Growth Standards (Multicentre Growth Reference study measures).
• Change in Height-for-age z-score (HAZ)/Length-for-age z-score (LAZ) [From enrollment to end of treatment at 3 months]: Change in Height-for-age z-score (HAZ)/Length-for-age z-score (LAZ) according to the WHO Growth Standards (Multicentre Growth Reference study measures).

Sex: All, ages: 6 Months to 59 Months, accepts healthy volunteers

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.

• Study Protocol and Statistical Analysis Plan (PDF, 2026-05-05)