An interventional study of 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. and Standard of Care (Investigator Selected) in Moderate Acute Malnutrition (MAM), Undernutrition and Wasting, sponsored by World Vision US. Enrolling by invitation at 1 site in Bangladesh. Open to participants aged 6 Months to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by World Vision US · Not applicable, Interventional, and Treatment
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:
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:
1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.
This study's planned enrollment of 400 is above the median of 118 across 843 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →World Vision US is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SOC group will receive basic health and nutrition interventions that align with Ministry of Health's protocols.
Other: Standard of Care (Investigator Selected)
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.
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.
Children will receive basic health and nutrition services, including infant and young child feeding counselling.
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
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
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
Weight-for-age (WAZ)
Average WAZ
Time frame: At end of treatment at 3 months
Average Mid-upper arm circumference (MUAC)
Average MUAC (mm)
Time frame: At the end of treatment at 3 months
Non-response
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.
Time frame: Within 4 months of enrollment; 1 month after attending second round of Hearth
Sustained Recovery
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.
Time frame: 6 months after receiving treatment
Alternative Sustained Recovery Definition (including WAZ)
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.
Time frame: 6 months after receiving treatment.
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.
Meal frequency
Meets minimum meal frequency standard
Time frame: From enrollment to end of treatment at 3 months.
Minimum Acceptable Diet (MAD)
Meets combined MDD + meal frequency
Time frame: From enrollment to end of treatment at 3 months.
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.
Child Illness Symptoms
Presence of illness (e.g., diarrhea, fever, ARI)
Time frame: From enrollment to end of treatment at 3 months.
Care-seeking Behaviour
Care sought for illness episode at health centre or hospital
Time frame: From enrollment to end of treatment at 3 months.
Handwashing practices
Reporting of washing hands at all 5 critical time points.
Time frame: From enrollment to end of treatment at 3 months.
Caregiver psychological wellbeing
5 separate Caregiver Psychological Distress questions will be asked, following WHO-5 Well-Being Index to assess caregiver psychological wellbeing. Each question will have a scale 0 to 5, 0 being 'Never' and 5 being "All the time". The score for 5 questions will be totaled and if it is below 13, it indicates poor wellbeing and is an indication for depression under ICD-10. Caregivers with below a score of 13 will be referred for formal clinical services.
Time frame: From enrollment to end of treatment at 3 months.
Cost-effectiveness of PDH
To assess the cost-effectiveness of PDH, taking into the costs of program design, implementation, and caregiver time.
Time frame: From enrollment to six months.
Change in WHZ/WLZ
Change in Weight-for-Height Z-score or Weight-for-Length z-score according to the WHO Growth Standards (Multicentre Growth Reference study measures).
Time frame: From enrollment to end of treatment at 3 months
High vs. Low Risk MAM Recovery
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.
Time frame: From enrollment to end of treatment at 3 months
Change in WAZ
Change in Weight-for-age z-score according to the WHO Growth Standards (Multicentre Growth Reference study measures).
Time frame: From enrollment to end of treatment at 3 months
Change in Height-for-age z-score (HAZ)/Length-for-age z-score (LAZ)
Change in Height-for-age z-score (HAZ)/Length-for-age z-score (LAZ) according to the WHO Growth Standards (Multicentre Growth Reference study measures).
Time frame: From enrollment to end of treatment at 3 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data underlying the results of this study, along with a data dictionary, study protocol, statistical analysis plan, study tools, and analytical code, will be shared. All data will be anonymized by removing direct identifiers and minimizing re-identification risk through appropriate treatment of indirect identifiers. The dataset and accompanying documentation will be deposited in the London School of Hygiene \& Tropical Medicine (LSHTM) Data Compass repository, where a DOI will be assigned to support transparency and reuse. Data will be made available upon publication (or within a specified period thereafter) under a controlled access model, whereby researchers with a legitimate scientific interest may request access subject to approval and agreement to data use conditions, in line with ethical approvals and participant consent.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
Data sharing details ↗ · osf.io
Started Jul 2026 (actual). Primary completion is estimated for Nov 2026, 4 months after the start.
Of 392 non-industry interventional studies with no phase under Malnutrition, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 4 months is below that.
Counting every sponsor, half of 418 studies reached it within 22 months; a quarter within 11 and three quarters within 37.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 21, 2026: start May 2026 → Jul 2026, primary completion Sep 2026 → Nov 2026 and completion Dec 2026 → Mar 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.