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NCT Number: NCT07591064

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

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Key information

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

World Vision Bangladesh

Purbadhala, Mymensingh, Bangladesh

Location contact

A.B.M. Rasheduzzaman, MSS

SUB_INVESTIGATOR

Carmen Tse, MSc, HBSc

SUB_INVESTIGATOR

Iqbal Hossain, MBBS, DCH, PhD, FRCP

SUB_INVESTIGATOR

Joyanta Nath, MD

CONTACT

[email protected]

+88(0)1714014833

Md Tawhidur Rahman, MSS

SUB_INVESTIGATOR

Md. Golam Mustagir, MSc

SUB_INVESTIGATOR

Mezanur Rahman, MD

CONTACT

[email protected]

+88(0)1713490725

Miles Kirby, PhD

SUB_INVESTIGATOR

Sadia Afrin, MSc

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Standard of Care (Investigator Selected)

Other

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

Primary outcomes

  1. Rehabilitation of MAM (Primary)

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

    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.

Secondary outcomes

  1. Recovery of MAM

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

    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".

  2. Average daily weight gain (g/kg/day)

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

    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).

  3. Weight-for-age (WAZ)

    Time frame: At end of treatment at 3 months

    Average WAZ

  4. Average Mid-upper arm circumference (MUAC)

    Time frame: At the end of treatment at 3 months

    Average MUAC (mm)

  5. Non-response

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

    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.

  6. Sustained Recovery

    Time frame: 6 months after receiving treatment

    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.

  7. Alternative Sustained Recovery Definition (including WAZ)

    Time frame: 6 months after receiving treatment.

    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.

Other outcomes

  1. Minimum Dietary Diversity (MDD)

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

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

  2. Meal frequency

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

    Meets minimum meal frequency standard

  3. Minimum Acceptable Diet (MAD)

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

    Meets combined MDD + meal frequency

  4. Unhealthy Food Consumption

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

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

  5. Child Illness Symptoms

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

    Presence of illness (e.g., diarrhea, fever, ARI)

  6. Care-seeking Behaviour

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

    Care sought for illness episode at health centre or hospital

  7. Handwashing practices

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

    Reporting of washing hands at all 5 critical time points.

  8. Caregiver psychological wellbeing

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

    Caregiver mental health or wellbeing score

  9. Cost-effectiveness of PDH

    Time frame: From enrollment to six months.

    To assess the cost-effectiveness of PDH, taking into the costs of program design, implementation, and caregiver time.

  10. Change in WHZ/WLZ

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

    Change in WHZ/WLZ z-score

  11. High vs. Low Risk MAM Recovery

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

    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.

  12. Change in WAZ

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

    Change in WAZ

  13. Change in Height-for-age z-score (HAZ)/Length-for-age z-score (LAZ)

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

    Change in HAZ/LAZ

Study contacts

Contact information is provided by the study sponsor or research team.

Bidhan Krishna Sarker, MSS

CONTACT

[email protected]

+88(0)1712729941

Diane Baik, PhD (c), MSc, HBSc

CONTACT

[email protected]

929-225-4075

Sponsors and collaborators

Lead sponsor

World Vision US

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PD/Hearth MAM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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