Moderate Acute Malnutrition (MAM)PD/Hearth MAMNCT07591064
Effectiveness of Positive Deviance/Hearth in Treating Uncomplicated Moderate Acute Malnutrition in Children 6-59 Months in Mymensingh Division, Bangladesh
A study testing 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. in people with Moderate Acute Malnutrition (MAM) and Undernutrition, run by World Vision US at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Moderate Acute Malnutrition (MAM), Undernutrition, Wasting
- What is being tested?
- 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.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteBangladesh
- Study dates
- 8 Jul 2026to 21 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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?
Read more
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
- Moderate Acute Malnutrition (MAM), Undernutrition, Wasting
- Being tested
- 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., Standard of Care (Investigator Selected)
- Keywords
- Moderate acute malnutrition (MAM), Children, relapse, positive deviance/hearth
- Medical subject headings
- Malnutrition, Cachexia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) group | Other | SOC group will receive basic health and nutrition interventions that align with Ministry of Health's protocols. Receives: Other: Standard of Care (Investigator Selected) |
| Positive Deviance/Hearth (PDH) + SOC Group | Experimental | 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to end of treatment at 3 months
Secondary outcomes (7)
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".
Measured: 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).
Measured: From enrollment to end of treatment at 3 months
Weight-for-age (WAZ)
Average WAZ
Measured: At end of treatment at 3 months
Average Mid-upper arm circumference (MUAC)
Average MUAC (mm)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after receiving treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start8 Jul 2026
- Primary completion29 Nov 2026 (estimated)
- Study completion21 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Acute Malnutrition (MAM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized control trial with two arms. One arm will receive standard of care and the second arm will receive a food-based intervention program called, "Positive Deviance/Hearth".
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- World Vision US
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, International Centre for Diarrhoeal Disease Research, Bangladesh, World Vision
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591064
- Sponsor's protocol ID
- 32954
- Other IDs
- BGDOKREA0241
- Acronym
- PD/Hearth MAM
- Status last verified
- Oct 2026
- First submitted
- 8 May 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07591064
- Acronym / sponsor ID
- PD/Hearth MAM / 32954
- Conditions
- Moderate Acute Malnutrition (MAM), Undernutrition, Wasting
- Keywords
- Moderate acute malnutrition (MAM), Children, relapse, positive deviance/hearth
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- World Vision USUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, International Centre for Diarrhoeal Disease Research, Bangladesh, World Vision
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 29 Nov 2026 (estimated)
- Study completion
- 21 Mar 2027 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized control trial with two arms. One arm will receive standard of care and the second arm will receive a food-based intervention program called, "Positive Deviance/Hearth".
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) group | Other | Other: Standard of Care (Investigator Selected)SOC group will receive basic health and nutrition interventions that align with Ministry of Health's protocols. |
| Positive Deviance/Hearth (PDH) + SOC Group | Experimental | 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.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. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Positive Deviance/Hearth (PDH) + SOC Group |
| Standard of Care (Investigator Selected)Children will receive basic health and nutrition services, including infant and young child feeding counselling. | Other | Standard of Care (SOC) group |
Primary outcome
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.
7 secondary outcomes
Recovery of MAM
Time frame: From enrollment to end of treatment at 3 months
Average daily weight gain (g/kg/day)
Time frame: From enrollment to end of treatment at 3 months
Weight-for-age (WAZ)
Time frame: At end of treatment at 3 months
Average Mid-upper arm circumference (MUAC)
Time frame: At the end of treatment at 3 months
Non-response
Time frame: Within 4 months of enrollment; 1 month after attending second round of Hearth
Sustained Recovery
Time frame: 6 months after receiving treatment
Alternative Sustained Recovery Definition (including WAZ)
Time frame: 6 months after receiving treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- The study protocol, statistical analysis plan, consent forms, and qualitative and quantitative tools are all available here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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. in people with Moderate Acute Malnutrition (MAM) and Undernutrition, run by World Vision US at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehabilitation of MAM (Primary) (time frame: From enrollment to end of treatment at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.