Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BGDOKREA0241 | Other Grant/Funding Number | World Vision Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| London School of Hygiene and Tropical Medicine | OTHER |
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
| World Vision | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care (SOC) group | Other | SOC group will receive basic health and nutrition interventions that align with Ministry of Health's protocols. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to end of treatment at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | From enrollment to end of treatment at 3 months |
| Average daily weight gain (g/kg/day) |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum Dietary Diversity (MDD) | Child meets WHO MDD definition (fed 5 out of 8 food groups) | From enrollment to end of treatment at 3 months. |
| Meal frequency | Meets minimum meal frequency standard |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diane Baik, PhD (c), MSc, HBSc | Contact | 929-225-4075 | diane.baik@lshtm.ac.uk | |
| Bidhan Krishna Sarker, MSS | Contact | +88(0)1712729941 | bidhan@icddrb.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| World Vision Bangladesh | Purbadhala | Mymensingh | Bangladesh |
Not provided
| Label | URL |
|---|---|
| The study protocol, statistical analysis plan, consent forms, and qualitative and quantitative tools are all available here. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| https://doi.org/10.17605/OSF.I | Study Protocol, Statistical Analysis Plan, Consent Forms, and Tools | View IPD |
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.
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 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.
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2026 |
Not provided
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".
Not provided
Not provided
The data collectors/enumerators will also be masked in addition to the investigator and data analyzers until analysis is complete.
|
| Standard of Care (Investigator Selected) | Other | Children will receive basic health and nutrition services, including infant and young child feeding counselling. |
|
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). |
| From enrollment to end of treatment at 3 months |
| Weight-for-age (WAZ) | Average WAZ | At end of treatment at 3 months |
| Average Mid-upper arm circumference (MUAC) | Average MUAC (mm) | 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. | 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. | 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. | 6 months after receiving treatment. |
| From enrollment to end of treatment at 3 months. |
| Minimum Acceptable Diet (MAD) | Meets combined MDD + meal frequency | 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 | From enrollment to end of treatment at 3 months. |
| Child Illness Symptoms | Presence of illness (e.g., diarrhea, fever, ARI) | From enrollment to end of treatment at 3 months. |
| Care-seeking Behaviour | Care sought for illness episode at health centre or hospital | From enrollment to end of treatment at 3 months. |
| Handwashing practices | Reporting of washing hands at all 5 critical time points. | From enrollment to end of treatment at 3 months. |
| Caregiver psychological wellbeing | Caregiver mental health or wellbeing score | 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. | From enrollment to six months. |
| Change in WHZ/WLZ | Change in WHZ/WLZ z-score | 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. | From enrollment to end of treatment at 3 months |
| Change in WAZ | Change in WAZ | 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 HAZ/LAZ | From enrollment to end of treatment at 3 months |
| May 8, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D002100 | Cachexia |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided