Effectiveness of Positive Deviance/Hearth in Treating Uncomplicated Moderate Acute Malnutrition in Children 6-59 Months in Mymensingh Division, Bangladesh (PD/Hearth MAM)
2026年5月8日 更新者：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
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
400
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Diane Baik, PhD (c), MSc, HBSc
- 電話番号：929-225-4075
- メール：diane.baik@lshtm.ac.uk
研究連絡先のバックアップ
- 名前：Bidhan Krishna Sarker, MSS
- 電話番号：+88(0)1712729941
- メール：bidhan@icddrb.org
研究場所
-
-
Mymensingh
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Purbadhala、Mymensingh、バングラデシュ
- World Vision Bangladesh
-
コンタクト：
- Mezanur Rahman, MD
- 電話番号：+88(0)1713490725
- メール：mdmezanur_rahman@wvi.org
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コンタクト：
- Joyanta Nath, MD
- 電話番号：+88(0)1714014833
- メール：joyanta_nath@wvi.org
-
副調査官：
- Carmen Tse, MSc, HBSc
-
副調査官：
- Miles Kirby, PhD
-
副調査官：
- Iqbal Hossain, MBBS, DCH, PhD, FRCP
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副調査官：
- Md Tawhidur Rahman, MSS
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副調査官：
- A.B.M. Rasheduzzaman, MSS
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副調査官：
- Md. Golam Mustagir, MSc
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副調査官：
- Sadia Afrin, MSc
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rehabilitation of MAM (Primary)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recovery of MAM
時間枠：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
|
|
Average daily weight gain (g/kg/day)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Minimum Dietary Diversity (MDD)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：From enrollment to end of treatment at 3 months.
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Caregiver mental health or wellbeing score
|
From enrollment to end of treatment at 3 months.
|
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Cost-effectiveness of PDH
時間枠：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
時間枠：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
時間枠：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.
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From enrollment to end of treatment at 3 months
|
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Change in WAZ
時間枠：From enrollment to end of treatment at 3 months
|
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)
時間枠：From enrollment to end of treatment at 3 months
|
Change in HAZ/LAZ
|
From enrollment to end of treatment at 3 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月16日
一次修了 (推定)
2026年9月18日
研究の完了 (推定)
2026年12月17日
試験登録日
最初に提出
2026年5月8日
QC基準を満たした最初の提出物
2026年5月8日
最初の投稿 (実際)
2026年5月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月15日
QC基準を満たした最後の更新が送信されました
2026年5月8日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 32954
- BGDOKREA0241 (その他の助成金/資金番号：World Vision Korea)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
試験データ・資料
-
Study Protocol, Statistical Analysis Plan, Consent Forms, and Tools
情報識別子：https://doi.org/10.17605/OSF.I
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。