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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. mai 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

400

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Bidhan Krishna Sarker, MSS
  • Telefonnummer: +88(0)1712729941
  • E-post: bidhan@icddrb.org

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Standard of Care (SOC) group
SOC group will receive basic health and nutrition interventions that align with Ministry of Health's protocols.
Annen: Standard of Care (Investigator Selected)
Children will receive basic health and nutrition services, including infant and young child feeding counselling.
Eksperimentell: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rehabilitation of MAM (Primary)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Recovery of MAM
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: At end of treatment at 3 months
Average WAZ
At end of treatment at 3 months
Average Mid-upper arm circumference (MUAC)
Tidsramme: At the end of treatment at 3 months
Average MUAC (mm)
At the end of treatment at 3 months
Non-response
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Minimum Dietary Diversity (MDD)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: From enrollment to end of treatment at 3 months
Change in HAZ/LAZ
From enrollment to end of treatment at 3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

World Vision US

Samarbeidspartnere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

16. mai 2026

Primær fullføring (Antatt)

18. september 2026

Studiet fullført (Antatt)

17. desember 2026

Datoer for studieregistrering

Først innsendt

8. mai 2026

Først innsendt som oppfylte QC-kriteriene

8. mai 2026

Først lagt ut (Faktiske)

15. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 32954
  • BGDOKREA0241 (Annet stipend/finansieringsnummer: World Vision Korea)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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).

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Studiedata/dokumenter

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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