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

NCT07591064 | Not Yet Recruiting DMC

• 2 other identifiers: 32954BGDOKREA0241
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Wasting; Undernutrition; Moderate Acute Malnutrition (MAM)

Keywords

Moderate acute malnutrition (MAM); Children; relapse; positive deviance/hearth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Recovery of MAM

  From enrollment to end of treatment at 3 months

• Average daily weight gain (g/kg/day)

  From enrollment to end of treatment at 3 months

• Weight-for-age (WAZ)

  At end of treatment at 3 months

• Average Mid-upper arm circumference (MUAC)

  At the end of treatment at 3 months

• Non-response

  Within 4 months of enrollment; 1 month after attending second round of Hearth

Other Outcomes (13)

• Minimum Dietary Diversity (MDD)

  From enrollment to end of treatment at 3 months.

• Meal frequency

  From enrollment to end of treatment at 3 months.

• Minimum Acceptable Diet (MAD)

  From enrollment to end of treatment at 3 months.

Study Arms (2)

Standard of Care (SOC) group

OTHER

SOC group will receive basic health and nutrition interventions that align with Ministry of Health's protocols.

Other: Standard of Care (Investigator Selected)

Positive Deviance/Hearth (PDH) + SOC Group

EXPERIMENTAL

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.

Interventions

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.

Positive Deviance/Hearth (PDH) + SOC Group

Standard of Care (Investigator Selected) OTHER

Children will receive basic health and nutrition services, including infant and young child feeding counselling.

Standard of Care (SOC) group

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Child is not between 6-52 months of age at Baseline
• 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.

Sponsors & Collaborators

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

Study Sites (1)

World Vision Bangladesh

Purbadhala, Mymensingh, Bangladesh

Location

Related Links

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

MeSH Terms

Conditions

Malnutrition; Cachexia; Recurrence

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Diane Baik, PhD (c), MSc, HBSc

CONTACT

929-225-4075; diane.baik@lshtm.ac.uk

Bidhan Krishna Sarker, MSS

CONTACT

+88(0)1712729941; bidhan@icddrb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The data collectors/enumerators will also be masked in addition to the investigator and data analyzers until analysis is complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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".

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 15, 2026
• Study Start: May 16, 2026
• Primary Completion (Estimated): September 18, 2026
• Study Completion (Estimated): December 17, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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).
• 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.

Locations

BA (1)