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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 maio de 2026 atualizado 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

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

400

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

  • Nome: Bidhan Krishna Sarker, MSS
  • Número de telefone: +88(0)1712729941
  • E-mail: bidhan@icddrb.org

Locais de estudo

  • Bangladesh
    • Mymensingh
      • Purbadhala, Mymensingh, Bangladesh
        • World Vision Bangladesh
        • Contato:
        • Contato:
        • Subinvestigador:
          • Carmen Tse, MSc, HBSc
        • Subinvestigador:
          • Miles Kirby, PhD
        • Subinvestigador:
          • Iqbal Hossain, MBBS, DCH, PhD, FRCP
        • Subinvestigador:
          • Md Tawhidur Rahman, MSS
        • Subinvestigador:
          • A.B.M. Rasheduzzaman, MSS
        • Subinvestigador:
          • Md. Golam Mustagir, MSc
        • Subinvestigador:
          • Sadia Afrin, MSc

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: Standard of Care (SOC) group
SOC group will receive basic health and nutrition interventions that align with Ministry of Health's protocols.
Outro: Standard of Care (Investigator Selected)
Children will receive basic health and nutrition services, including infant and young child feeding counselling.
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.
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Rehabilitation of MAM (Primary)
Prazo: 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.
From enrollment to end of treatment at 3 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Recovery of MAM
Prazo: 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".
From enrollment to end of treatment at 3 months
Average daily weight gain (g/kg/day)
Prazo: 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).
From enrollment to end of treatment at 3 months
Weight-for-age (WAZ)
Prazo: At end of treatment at 3 months
Average WAZ
At end of treatment at 3 months
Average Mid-upper arm circumference (MUAC)
Prazo: At the end of treatment at 3 months
Average MUAC (mm)
At the end of treatment at 3 months
Non-response
Prazo: 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.
Within 4 months of enrollment; 1 month after attending second round of Hearth
Sustained Recovery
Prazo: 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.
6 months after receiving treatment
Alternative Sustained Recovery Definition (including WAZ)
Prazo: 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.
6 months after receiving treatment.

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Minimum Dietary Diversity (MDD)
Prazo: From enrollment to end of treatment at 3 months.
Child meets WHO MDD definition (fed 5 out of 8 food groups)
From enrollment to end of treatment at 3 months.
Meal frequency
Prazo: From enrollment to end of treatment at 3 months.
Meets minimum meal frequency standard
From enrollment to end of treatment at 3 months.
Minimum Acceptable Diet (MAD)
Prazo: From enrollment to end of treatment at 3 months.
Meets combined MDD + meal frequency
From enrollment to end of treatment at 3 months.
Unhealthy Food Consumption
Prazo: From enrollment to end of treatment at 3 months.
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
Prazo: From enrollment to end of treatment at 3 months.
Presence of illness (e.g., diarrhea, fever, ARI)
From enrollment to end of treatment at 3 months.
Care-seeking Behaviour
Prazo: From enrollment to end of treatment at 3 months.
Care sought for illness episode at health centre or hospital
From enrollment to end of treatment at 3 months.
Handwashing practices
Prazo: From enrollment to end of treatment at 3 months.
Reporting of washing hands at all 5 critical time points.
From enrollment to end of treatment at 3 months.
Caregiver psychological wellbeing
Prazo: From enrollment to end of treatment at 3 months.
Caregiver mental health or wellbeing score
From enrollment to end of treatment at 3 months.
Cost-effectiveness of PDH
Prazo: From enrollment to six months.
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
Prazo: From enrollment to end of treatment at 3 months
Change in WHZ/WLZ z-score
From enrollment to end of treatment at 3 months
High vs. Low Risk MAM Recovery
Prazo: 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.
From enrollment to end of treatment at 3 months
Change in WAZ
Prazo: From enrollment to end of treatment at 3 months
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)
Prazo: From enrollment to end of treatment at 3 months
Change in HAZ/LAZ
From enrollment to end of treatment at 3 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

World Vision US

Colaboradores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

16 de maio de 2026

Conclusão Primária (Estimado)

18 de setembro de 2026

Conclusão do estudo (Estimado)

17 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

8 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de maio de 2026

Primeira postagem (Real)

15 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 32954
  • BGDOKREA0241 (Número de outro subsídio/financiamento: World Vision Korea)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de 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).

Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF
  • ANALYTIC_CODE
  • CSR

Dados/documentos do estudo

  1. Study Protocol, Statistical Analysis Plan, Consent Forms, and Tools
    Identificador de informação: https://doi.org/10.17605/OSF.I

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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