Effectiveness of Positive Deviance/Hearth in Treating Uncomplicated Moderate Acute Malnutrition in Children 6-59 Months in Mymensingh Division, Bangladesh

Официальное название

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

Обзор

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

Вмешательства

• Другое 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.
• Другое Standard of Care (Investigator Selected)
  Children will receive basic health and nutrition services, including infant and young child feeding counselling.

Первичные конечные точки

• Rehabilitation of MAM (Primary) [Срок оценки: From enrollment to end of treatment at 3 months]

Вторичные конечные точки (7)

• Recovery of MAM [Срок оценки: From enrollment to end of treatment at 3 months]
• Average daily weight gain (g/kg/day) [Срок оценки: From enrollment to end of treatment at 3 months]
• Weight-for-age (WAZ) [Срок оценки: At end of treatment at 3 months]
• Average Mid-upper arm circumference (MUAC) [Срок оценки: At the end of treatment at 3 months]
• Non-response [Срок оценки: Within 4 months of enrollment; 1 month after attending second round of Hearth]
• Sustained Recovery [Срок оценки: 6 months after receiving treatment]
• Alternative Sustained Recovery Definition (including WAZ) [Срок оценки: 6 months after receiving treatment.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Bangladesh · 1 центр

• World Vision Bangladesh — Purbadhala

Идентификаторы

NCT: NCT07591064 · 32954 · BGDOKREA0241

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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