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

The Effectiveness of Positive Deviance/Hearth (PDH), a Local Dietary Approach, to Treat Uncomplicated Moderate Acute Malnutrition (MAM) in Children 6-59 Months in Mymensingh, Bangladesh

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

Study Overview

• Status: Not yet recruiting
• Conditions: Wasting; Undernutrition; Moderate Acute Malnutrition (MAM)
• Intervention / Treatment: Other: Standard of Care (Investigator Selected); Other: 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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diane Baik, PhD (c), MSc, HBSc; Phone Number: 929-225-4075; Email: diane.baik@lshtm.ac.uk
• Study Contact Backup: Name: Bidhan Krishna Sarker, MSS; Phone Number: +88(0)1712729941; Email: bidhan@icddrb.org

Study Locations

• Bangladesh
  • Mymensingh
    • Purbadhala, Mymensingh, Bangladesh
      • World Vision Bangladesh
      • Contact: Mezanur Rahman, MD; Phone Number: +88(0)1713490725; Email: mdmezanur_rahman@wvi.org
      • Contact: Joyanta Nath, MD; Phone Number: +88(0)1714014833; Email: joyanta_nath@wvi.org
      • Sub-Investigator: Carmen Tse, MSc, HBSc
      • Sub-Investigator: Miles Kirby, PhD
      • Sub-Investigator: Iqbal Hossain, MBBS, DCH, PhD, FRCP
      • Sub-Investigator: Md Tawhidur Rahman, MSS
      • Sub-Investigator: A.B.M. Rasheduzzaman, MSS
      • Sub-Investigator: Md. Golam Mustagir, MSc
      • Sub-Investigator: Sadia Afrin, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard of Care (SOC) group; SOC group will receive basic health and nutrition interventions that align with Ministry of Health's protocols.	Other: Standard of Care (Investigator Selected); Children will receive basic health and nutrition services, including infant and young child feeding counselling.
Experimental: Positive Deviance/Hearth (PDH) + SOC Group; PDH+SOC group, in addition to the SOC interventions, will receive 12 days of Hearth sessions (nutrition education) where caregivers of MAM children learn to cook and feed nutrient-dense meals using local ingredients they bring to the session. The caregivers will also hear six key contextualized messages developed through a formative research process prior to starting the Hearth sessions.	Other: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rehabilitation of MAM (Primary)	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.	From enrollment to end of treatment at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery of MAM	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".	From enrollment to end of treatment at 3 months
Average daily weight gain (g/kg/day)	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).	From enrollment to end of treatment at 3 months
Weight-for-age (WAZ)	Average WAZ	At end of treatment at 3 months
Average Mid-upper arm circumference (MUAC)	Average MUAC (mm)	At the end of treatment at 3 months
Non-response	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.	Within 4 months of enrollment; 1 month after attending second round of Hearth
Sustained Recovery	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.	6 months after receiving treatment
Alternative Sustained Recovery Definition (including WAZ)	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.	6 months after receiving treatment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimum Dietary Diversity (MDD)	Child meets WHO MDD definition (fed 5 out of 8 food groups)	From enrollment to end of treatment at 3 months.
Meal frequency	Meets minimum meal frequency standard	From enrollment to end of treatment at 3 months.
Minimum Acceptable Diet (MAD)	Meets combined MDD + meal frequency	From enrollment to end of treatment at 3 months.
Unhealthy Food Consumption	Consumption of unhealthy foods/beverages; Yes to any of the questions of eating unhealth foods	From enrollment to end of treatment at 3 months.
Child Illness Symptoms	Presence of illness (e.g., diarrhea, fever, ARI)	From enrollment to end of treatment at 3 months.
Care-seeking Behaviour	Care sought for illness episode at health centre or hospital	From enrollment to end of treatment at 3 months.
Handwashing practices	Reporting of washing hands at all 5 critical time points.	From enrollment to end of treatment at 3 months.
Caregiver psychological wellbeing	Caregiver mental health or wellbeing score	From enrollment to end of treatment at 3 months.
Cost-effectiveness of PDH	To assess the cost-effectiveness of PDH, taking into the costs of program design, implementation, and caregiver time.	From enrollment to six months.
Change in WHZ/WLZ	Change in WHZ/WLZ z-score	From enrollment to end of treatment at 3 months
High vs. Low Risk MAM Recovery	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.	From enrollment to end of treatment at 3 months
Change in WAZ	Change in WAZ	From enrollment to end of treatment at 3 months
Change in Height-for-age z-score (HAZ)/Length-for-age z-score (LAZ)	Change in HAZ/LAZ	From enrollment to end of treatment at 3 months

Collaborators and Investigators

• Sponsor: World Vision US
• Collaborators: London School of Hygiene and Tropical Medicine; International Centre for Diarrhoeal Disease Research, Bangladesh; World Vision

Publications and helpful links

Helpful Links

• The study protocol, statistical analysis plan, consent forms, and qualitative and quantitative tools are all available here.

Study record dates

Study Major Dates

• Study Start (Estimated): May 16, 2026
• Primary Completion (Estimated): September 18, 2026
• Study Completion (Estimated): December 17, 2026

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: relapse; Children; Moderate acute malnutrition (MAM); positive deviance/hearth
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Disease Attributes; Body Weight; Body Weight Changes; Weight Loss; Thinness; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Malnutrition; Recurrence; Cachexia; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 32954; BGDOKREA0241 (Other Grant/Funding Number: World Vision Korea)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the results of this study, along with a data dictionary, study protocol, statistical analysis plan, study tools, and analytical code, will be shared. All data will be anonymized by removing direct identifiers and minimizing re-identification risk through appropriate treatment of indirect identifiers. The dataset and accompanying documentation will be deposited in the London School of Hygiene & Tropical Medicine (LSHTM) Data Compass repository, where a DOI will be assigned to support transparency and reuse. Data will be made available upon publication (or within a specified period thereafter) under a controlled access model, whereby researchers with a legitimate scientific interest may request access subject to approval and agreement to data use conditions, in line with ethical approvals and participant consent.
• IPD Sharing Time Frame: The study protocol, statistical analysis plan, consent forms, and quantitative and qualitative tools/questionnaires will be available May 2026 and the data will be available starting February 2027 and accessible for 10 years after publication (June 2037).
• IPD Sharing Access Criteria: Access to the anonymized individual participant data (IPD) and supporting documentation will be provided to **qualified researchers, policymakers, and other stakeholders with a legitimate scientific or public health interest**. Users will be able to access the **de-identified dataset, data dictionary, study protocol, statistical analysis plan, study tools, and, where applicable, analytical code**. The data will be hosted in the **Open Science Framework repository**, where it will be assigned a DOI. Access will be granted under a **controlled access model**: interested users will be required to submit a request outlining the intended use of the data and agree to the repository's data use conditions. Upon approval, access will be provided through the repository in a secure and responsible manner, in line with ethical approvals and participant consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Study Data/Documents

1. Study Protocol, Statistical Analysis Plan, Consent Forms, and Tools
   Information identifier: https://doi.org/10.17605/OSF.I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No