Effectiveness of Positive Deviance/Hearth in Treating Uncomplicated Moderate Acute Malnutrition in Children 6-59 Months in Mymensingh Division, Bangladesh (PD/Hearth MAM)
2026년 5월 8일 업데이트: 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
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
400
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Diane Baik, PhD (c), MSc, HBSc
- 전화번호: 929-225-4075
- 이메일: diane.baik@lshtm.ac.uk
연구 연락처 백업
- 이름: Bidhan Krishna Sarker, MSS
- 전화번호: +88(0)1712729941
- 이메일: bidhan@icddrb.org
연구 장소
-
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Mymensingh
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Purbadhala, Mymensingh, 방글라데시
- World Vision Bangladesh
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연락하다:
- Mezanur Rahman, MD
- 전화번호: +88(0)1713490725
- 이메일: mdmezanur_rahman@wvi.org
-
연락하다:
- Joyanta Nath, MD
- 전화번호: +88(0)1714014833
- 이메일: joyanta_nath@wvi.org
-
부수사관:
- Carmen Tse, MSc, HBSc
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부수사관:
- Miles Kirby, PhD
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부수사관:
- Iqbal Hossain, MBBS, DCH, PhD, FRCP
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부수사관:
- Md Tawhidur Rahman, MSS
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부수사관:
- A.B.M. Rasheduzzaman, MSS
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부수사관:
- Md. Golam Mustagir, MSc
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부수사관:
- Sadia Afrin, MSc
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rehabilitation of MAM (Primary)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Recovery of MAM
기간: 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)
기간: 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
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Weight-for-age (WAZ)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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.
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Minimum Dietary Diversity (MDD)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: From enrollment to six months.
|
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
기간: 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
기간: 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
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 16일
기본 완료 (추정된)
2026년 9월 18일
연구 완료 (추정된)
2026년 12월 17일
연구 등록 날짜
최초 제출
2026년 5월 8일
QC 기준을 충족하는 최초 제출
2026년 5월 8일
처음 게시됨 (실제)
2026년 5월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 8일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 32954
- BGDOKREA0241 (기타 보조금/기금 번호: World Vision Korea)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
연구 데이터/문서
-
Study Protocol, Statistical Analysis Plan, Consent Forms, and Tools
정보 식별자: https://doi.org/10.17605/OSF.I
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .