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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-59
SponsorWorld Vision US

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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 intervention

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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Standard of Care (SOC) groupOther 1 intervention
Group B: Positive Deviance/Hearth (PDH) + SOC GroupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
From enrollment to end of treatment at 3 months

Secondary outcomes

1

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".

Time frame
From enrollment to end of treatment at 3 months
2

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).

Time frame
From enrollment to end of treatment at 3 months
3

Weight-for-age (WAZ)

Average WAZ

Time frame
At end of treatment at 3 months
4

Average Mid-upper arm circumference (MUAC)

Average MUAC (mm)

Time frame
At the end of treatment at 3 months

Other outcomes

1

Minimum Dietary Diversity (MDD)

Child meets WHO MDD definition (fed 5 out of 8 food groups)

Time frame
From enrollment to end of treatment at 3 months.
2

Meal frequency

Meets minimum meal frequency standard

Time frame
From enrollment to end of treatment at 3 months.
3

Minimum Acceptable Diet (MAD)

Meets combined MDD + meal frequency

Time frame
From enrollment to end of treatment at 3 months.
4

Unhealthy Food Consumption

Consumption of unhealthy foods/beverages; Yes to any of the questions of eating unhealth foods

Time frame
From enrollment to end of treatment at 3 months.

Sponsors and contacts

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World Vision US

Lead sponsor

London School of Hygiene and Tropical Medicine

Collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborator

World Vision

Collaborator

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