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 aktualisiert von: 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
Studienübersicht
Status
Noch keine Rekrutierung
Studientyp
Interventionell
Einschreibung (Geschätzt)
400
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Diane Baik, PhD (c), MSc, HBSc
- Telefonnummer: 929-225-4075
- E-Mail: diane.baik@lshtm.ac.uk
Studieren Sie die Kontaktsicherung
- Name: Bidhan Krishna Sarker, MSS
- Telefonnummer: +88(0)1712729941
- E-Mail: bidhan@icddrb.org
Studienorte
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-
Mymensingh
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Purbadhala, Mymensingh, Bangladesch
- World Vision Bangladesh
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Kontakt:
- Mezanur Rahman, MD
- Telefonnummer: +88(0)1713490725
- E-Mail: mdmezanur_rahman@wvi.org
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Kontakt:
- Joyanta Nath, MD
- Telefonnummer: +88(0)1714014833
- E-Mail: joyanta_nath@wvi.org
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Unterermittler:
- Carmen Tse, MSc, HBSc
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Unterermittler:
- Miles Kirby, PhD
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Unterermittler:
- Iqbal Hossain, MBBS, DCH, PhD, FRCP
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Unterermittler:
- Md Tawhidur Rahman, MSS
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Unterermittler:
- A.B.M. Rasheduzzaman, MSS
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Unterermittler:
- Md. Golam Mustagir, MSc
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Unterermittler:
- Sadia Afrin, MSc
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Sonstiges: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Rehabilitation of MAM (Primary)
Zeitfenster: 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.
|
From enrollment to end of treatment at 3 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Recovery of MAM
Zeitfenster: 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".
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From enrollment to end of treatment at 3 months
|
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Average daily weight gain (g/kg/day)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Minimum Dietary Diversity (MDD)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
16. Mai 2026
Primärer Abschluss (Geschätzt)
18. September 2026
Studienabschluss (Geschätzt)
17. Dezember 2026
Studienanmeldedaten
Zuerst eingereicht
8. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. Mai 2026
Zuerst gepostet (Tatsächlich)
15. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
15. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Ernährungsstörungen
- Krankheitsattribute
- Körpergewicht
- Änderungen des Körpergewichts
- Gewichtsverlust
- Dünnheit
- Pathologische Zustände, Anzeichen und Symptome
- Ernährungs- und Stoffwechselerkrankungen
- Anzeichen und Symptome
- Unterernährung
- Wiederauftreten
- Kachexie
- Verwaltung des Gesundheitswesens
- Qualität, Zugang und Bewertung im Gesundheitswesen
- Qualität der Gesundheitsversorgung
- Qualitätsindikatoren, Gesundheitsversorgung
- Sorgfalt
Andere Studien-ID-Nummern
- 32954
- BGDOKREA0241 (Andere Zuschuss-/Finanzierungsnummer: World Vision Korea)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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.
IPD-Sharing-Zeitrahmen
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).
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- ANALYTIC_CODE
- CSR
Studiendaten/Dokumente
-
Study Protocol, Statistical Analysis Plan, Consent Forms, and Tools
Informationskennung: https://doi.org/10.17605/OSF.I
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .