Effectiveness of Positive Deviance/Hearth in Treating Uncomplicated Moderate Acute Malnutrition in Children 6-59 Months in Mymensingh Division, Bangladesh (PD/Hearth MAM)
8 mai 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
400
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Diane Baik, PhD (c), MSc, HBSc
- Numéro de téléphone: 929-225-4075
- E-mail: diane.baik@lshtm.ac.uk
Sauvegarde des contacts de l'étude
- Nom: Bidhan Krishna Sarker, MSS
- Numéro de téléphone: +88(0)1712729941
- E-mail: bidhan@icddrb.org
Lieux d'étude
-
-
Mymensingh
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Purbadhala, Mymensingh, Bengladesh
- World Vision Bangladesh
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Contact:
- Mezanur Rahman, MD
- Numéro de téléphone: +88(0)1713490725
- E-mail: mdmezanur_rahman@wvi.org
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Contact:
- Joyanta Nath, MD
- Numéro de téléphone: +88(0)1714014833
- E-mail: joyanta_nath@wvi.org
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Sous-enquêteur:
- Carmen Tse, MSc, HBSc
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Sous-enquêteur:
- Miles Kirby, PhD
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Sous-enquêteur:
- Iqbal Hossain, MBBS, DCH, PhD, FRCP
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Sous-enquêteur:
- Md Tawhidur Rahman, MSS
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Sous-enquêteur:
- A.B.M. Rasheduzzaman, MSS
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Sous-enquêteur:
- Md. Golam Mustagir, MSc
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Sous-enquêteur:
- Sadia Afrin, MSc
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: 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.
|
|
Expérimental: 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.
|
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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rehabilitation of MAM (Primary)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Recovery of MAM
Délai: 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)
Délai: 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).
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From enrollment to end of treatment at 3 months
|
|
Weight-for-age (WAZ)
Délai: 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)
Délai: At the end of treatment at 3 months
|
Average MUAC (mm)
|
At the end of treatment at 3 months
|
|
Non-response
Délai: 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
Délai: 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)
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Minimum Dietary Diversity (MDD)
Délai: 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
Délai: 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)
Délai: 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
Délai: From enrollment to end of treatment at 3 months.
|
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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: From enrollment to end of treatment at 3 months
|
Change in HAZ/LAZ
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From enrollment to end of treatment at 3 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
16 mai 2026
Achèvement primaire (Estimé)
18 septembre 2026
Achèvement de l'étude (Estimé)
17 décembre 2026
Dates d'inscription aux études
Première soumission
8 mai 2026
Première soumission répondant aux critères de contrôle qualité
8 mai 2026
Première publication (Réel)
15 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Troubles nutritionnels
- Attributs de la maladie
- Poids
- Changements de poids corporel
- Perte de poids
- Minceur
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Signes et symptômes
- Malnutrition
- Récurrence
- Cachexie
- Administration des services de santé
- Qualité des soins de santé, accès et évaluation
- Qualité des soins de santé
- Indicateurs de qualité, soins de santé
- Standard de soins
Autres numéros d'identification d'étude
- 32954
- BGDOKREA0241 (Autre subvention/numéro de financement: World Vision Korea)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Délai de partage 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).
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
- RSE
Données/documents d'étude
-
Study Protocol, Statistical Analysis Plan, Consent Forms, and Tools
Identifiant des informations: https://doi.org/10.17605/OSF.I
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .