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

NCT07591064 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-05-15

No results posted yet for this study

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)

Interventions

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.

OTHER

Standard of Care (Investigator Selected)

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

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • World Vision

    collaborator OTHER

  • World Vision US

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-16
Primary Completion
2026-09-18
Completion
2026-12-17

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07591064 on ClinicalTrials.gov