Effectiveness of Positive Deviance/Hearth in Treating Uncomplicated Moderate Acute Malnutrition in Children 6-59 Months in Mymensingh Division, Bangladesh (PD/Hearth MAM)
8 de mayo de 2026 actualizado por: World Vision US
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?
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
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
400
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Diane Baik, PhD (c), MSc, HBSc
- Número de teléfono: 929-225-4075
- Correo electrónico: diane.baik@lshtm.ac.uk
Copia de seguridad de contactos de estudio
- Nombre: Bidhan Krishna Sarker, MSS
- Número de teléfono: +88(0)1712729941
- Correo electrónico: bidhan@icddrb.org
Ubicaciones de estudio
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Mymensingh
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Purbadhala, Mymensingh, Bangladesh
- World Vision Bangladesh
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Contacto:
- Mezanur Rahman, MD
- Número de teléfono: +88(0)1713490725
- Correo electrónico: mdmezanur_rahman@wvi.org
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Contacto:
- Joyanta Nath, MD
- Número de teléfono: +88(0)1714014833
- Correo electrónico: joyanta_nath@wvi.org
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Sub-Investigador:
- Carmen Tse, MSc, HBSc
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Sub-Investigador:
- Miles Kirby, PhD
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Sub-Investigador:
- Iqbal Hossain, MBBS, DCH, PhD, FRCP
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Sub-Investigador:
- Md Tawhidur Rahman, MSS
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Sub-Investigador:
- A.B.M. Rasheduzzaman, MSS
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Sub-Investigador:
- Md. Golam Mustagir, MSc
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Sub-Investigador:
- Sadia Afrin, MSc
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Standard of Care (SOC) group
SOC group will receive basic health and nutrition interventions that align with Ministry of Health's protocols.
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Children will receive basic health and nutrition services, including infant and young child feeding counselling.
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Experimental: Positive Deviance/Hearth (PDH) + SOC Group
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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rehabilitation of MAM (Primary)
Periodo de tiempo: From enrollment to end of treatment at 3 months
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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.
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From enrollment to end of treatment at 3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recovery of MAM
Periodo de tiempo: From enrollment to end of treatment at 3 months
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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".
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From enrollment to end of treatment at 3 months
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Average daily weight gain (g/kg/day)
Periodo de tiempo: From enrollment to end of treatment at 3 months
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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).
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From enrollment to end of treatment at 3 months
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Weight-for-age (WAZ)
Periodo de tiempo: At end of treatment at 3 months
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Average WAZ
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At end of treatment at 3 months
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Average Mid-upper arm circumference (MUAC)
Periodo de tiempo: At the end of treatment at 3 months
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Average MUAC (mm)
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At the end of treatment at 3 months
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Non-response
Periodo de tiempo: Within 4 months of enrollment; 1 month after attending second round of Hearth
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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.
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Within 4 months of enrollment; 1 month after attending second round of Hearth
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Sustained Recovery
Periodo de tiempo: 6 months after receiving treatment
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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.
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6 months after receiving treatment
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Alternative Sustained Recovery Definition (including WAZ)
Periodo de tiempo: 6 months after receiving treatment.
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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.
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6 months after receiving treatment.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Minimum Dietary Diversity (MDD)
Periodo de tiempo: From enrollment to end of treatment at 3 months.
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Child meets WHO MDD definition (fed 5 out of 8 food groups)
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From enrollment to end of treatment at 3 months.
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Meal frequency
Periodo de tiempo: From enrollment to end of treatment at 3 months.
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Meets minimum meal frequency standard
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From enrollment to end of treatment at 3 months.
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Minimum Acceptable Diet (MAD)
Periodo de tiempo: From enrollment to end of treatment at 3 months.
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Meets combined MDD + meal frequency
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From enrollment to end of treatment at 3 months.
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Unhealthy Food Consumption
Periodo de tiempo: From enrollment to end of treatment at 3 months.
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Consumption of unhealthy foods/beverages; Yes to any of the questions of eating unhealth foods
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From enrollment to end of treatment at 3 months.
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Child Illness Symptoms
Periodo de tiempo: From enrollment to end of treatment at 3 months.
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Presence of illness (e.g., diarrhea, fever, ARI)
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From enrollment to end of treatment at 3 months.
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Care-seeking Behaviour
Periodo de tiempo: From enrollment to end of treatment at 3 months.
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Care sought for illness episode at health centre or hospital
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From enrollment to end of treatment at 3 months.
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Handwashing practices
Periodo de tiempo: From enrollment to end of treatment at 3 months.
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Reporting of washing hands at all 5 critical time points.
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From enrollment to end of treatment at 3 months.
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Caregiver psychological wellbeing
Periodo de tiempo: From enrollment to end of treatment at 3 months.
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Caregiver mental health or wellbeing score
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From enrollment to end of treatment at 3 months.
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Cost-effectiveness of PDH
Periodo de tiempo: From enrollment to six months.
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To assess the cost-effectiveness of PDH, taking into the costs of program design, implementation, and caregiver time.
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From enrollment to six months.
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Change in WHZ/WLZ
Periodo de tiempo: From enrollment to end of treatment at 3 months
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Change in WHZ/WLZ z-score
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From enrollment to end of treatment at 3 months
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High vs. Low Risk MAM Recovery
Periodo de tiempo: From enrollment to end of treatment at 3 months
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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.
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From enrollment to end of treatment at 3 months
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Change in WAZ
Periodo de tiempo: From enrollment to end of treatment at 3 months
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Change in WAZ
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From enrollment to end of treatment at 3 months
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Change in Height-for-age z-score (HAZ)/Length-for-age z-score (LAZ)
Periodo de tiempo: From enrollment to end of treatment at 3 months
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Change in HAZ/LAZ
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From enrollment to end of treatment at 3 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
16 de mayo de 2026
Finalización primaria (Estimado)
18 de septiembre de 2026
Finalización del estudio (Estimado)
17 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
8 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de mayo de 2026
Publicado por primera vez (Actual)
15 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Trastornos Nutricionales
- Atributos de la enfermedad
- Peso corporal
- Cambios en el peso corporal
- Pérdida de peso
- Delgadez
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Desnutrición
- Reaparición
- Caquexia
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Estándar de cuidado
Otros números de identificación del estudio
- 32954
- BGDOKREA0241 (Otro número de subvención/financiamiento: World Vision Korea)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
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).
Criterios de acceso compartido de IPD
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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Datos del estudio/Documentos
-
Study Protocol, Statistical Analysis Plan, Consent Forms, and Tools
Identificador de información: https://doi.org/10.17605/OSF.I
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .