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Clinical Trials/NCT07591064
NCT07591064Not yet recruitingNot Applicable

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

World Vision US1 site in 1 country400 target enrollmentStarted: May 16, 2026Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
400
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
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.

Eligibility Criteria

Ages
6 Months to 59 Months (Child)
Sex
All
Accepts 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.

Investigators

Sponsor
World Vision US
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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