[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639597":3},{"organization":4,"outcomesModule":7,"designInfo":81,"detailedDescription":86,"studyPopulation":86,"armGroups":93,"interventions":105,"overallOfficials":86,"centralContacts":114,"locations":124,"responsibleParty":161,"collaborators":163,"id":170,"slug":86,"hasResults":171,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":177,"sex":178,"minAge":179,"maxAge":180,"enrollmentInfo":181,"targetDuration":86,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":192,"overallStatus":197,"whyStopped":86,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},{"fullName":5,"class":6},"World Vision US","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"Rehabilitation of MAM (Primary)","Child will be considered rehabilitated when the child is no longer MAM, definition is: Weight-for-Height Z-score (WHZ)\u002FWeight-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",[14,17,20,24,28,32,36],{"measure":15,"description":16,"timeFrame":12},"Recovery of MAM","Child meets the following criteria: WHZ\u002FWLZ ≥ -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\".",{"measure":18,"description":19,"timeFrame":12},"Average daily weight gain (g\u002Fkg\u002Fday)","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).",{"measure":21,"description":22,"timeFrame":23},"Weight-for-age (WAZ)","Average WAZ","At end of treatment at 3 months",{"measure":25,"description":26,"timeFrame":27},"Average Mid-upper arm circumference (MUAC)","Average MUAC (mm)","At the end of treatment at 3 months",{"measure":29,"description":30,"timeFrame":31},"Non-response","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\u002FWLZ ≥ -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",{"measure":33,"description":34,"timeFrame":35},"Sustained Recovery","Child who met rehabilitation criteria at 3 months and sustained recovery for at least 6 months. Recovery definition is WHZ\u002FWLZ ≥ -2.0 SD or MUAC ≥ 125 mm (based on admission criterion), and absence of bilateral pitting oedema.","6 months after receiving treatment",{"measure":37,"description":38,"timeFrame":39},"Alternative Sustained Recovery Definition (including WAZ)","Child recovered at 3 months but at 6 months has WHZ\u002FWLZ \\\u003C -2.0 SD or MUAC \\\u003C 125 mm. Recovery definition is: WHZ\u002FWLZ ≥ -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.",[41,45,48,51,54,57,60,63,66,70,73,76,78],{"measure":42,"description":43,"timeFrame":44},"Minimum Dietary Diversity (MDD)","Child meets WHO MDD definition (fed 5 out of 8 food groups)","From enrollment to end of treatment at 3 months.",{"measure":46,"description":47,"timeFrame":44},"Meal frequency","Meets minimum meal frequency standard",{"measure":49,"description":50,"timeFrame":44},"Minimum Acceptable Diet (MAD)","Meets combined MDD + meal frequency",{"measure":52,"description":53,"timeFrame":44},"Unhealthy Food Consumption","Consumption of unhealthy foods\u002Fbeverages; Yes to any of the questions of eating unhealth foods",{"measure":55,"description":56,"timeFrame":44},"Child Illness Symptoms","Presence of illness (e.g., diarrhea, fever, ARI)",{"measure":58,"description":59,"timeFrame":44},"Care-seeking Behaviour","Care sought for illness episode at health centre or hospital",{"measure":61,"description":62,"timeFrame":44},"Handwashing practices","Reporting of washing hands at all 5 critical time points.",{"measure":64,"description":65,"timeFrame":44},"Caregiver psychological wellbeing","Caregiver mental health or wellbeing score",{"measure":67,"description":68,"timeFrame":69},"Cost-effectiveness of PDH","To assess the cost-effectiveness of PDH, taking into the costs of program design, implementation, and caregiver time.","From enrollment to six months.",{"measure":71,"description":72,"timeFrame":12},"Change in WHZ\u002FWLZ","Change in WHZ\u002FWLZ z-score",{"measure":74,"description":75,"timeFrame":12},"High vs. Low Risk MAM Recovery","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.",{"measure":77,"description":77,"timeFrame":12},"Change in WAZ",{"measure":79,"description":80,"timeFrame":12},"Change in Height-for-age z-score (HAZ)\u002FLength-for-age z-score (LAZ)","Change in HAZ\u002FLAZ",{"allocation":82,"interventionModel":83,"interventionModelDescription":84,"primaryPurpose":85,"observationalModel":86,"timePerspective":86,"maskingInfo":87},"RANDOMIZED","PARALLEL","Cluster randomized control trial with two arms. One arm will receive standard of care and the second arm will receive a food-based intervention program called, \"Positive Deviance\u002FHearth\".","TREATMENT",null,{"masking":88,"maskingDescription":89,"whoMasked":90},"DOUBLE","The data collectors\u002Fenumerators will also be masked in addition to the investigator and data analyzers until analysis is complete.",[91,92],"INVESTIGATOR","OUTCOMES_ASSESSOR",[94,99],{"label":95,"type":6,"description":96,"interventionNames":97},"Standard of Care (SOC) group","SOC group will receive basic health and nutrition interventions that align with Ministry of Health's protocols.",[98],"Other: Standard of Care (Investigator Selected)",{"label":100,"type":101,"description":102,"interventionNames":103},"Positive Deviance\u002FHearth (PDH) + SOC Group","EXPERIMENTAL","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.",[104],"Other: PD\u002FHearth 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.",[106,110],{"type":6,"name":107,"description":108,"armGroupLabels":109,"otherNames":86},"PD\u002FHearth 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\u002FHearth 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.",[100],{"type":6,"name":111,"description":112,"armGroupLabels":113,"otherNames":86},"Standard of Care (Investigator Selected)","Children will receive basic health and nutrition services, including infant and young child feeding counselling.",[95],[115,120],{"name":116,"role":117,"phone":118,"phoneExt":86,"email":119},"Diane Baik, PhD (c), MSc, HBSc","CONTACT","929-225-4075","diane.baik@lshtm.ac.uk",{"name":121,"role":117,"phone":122,"phoneExt":86,"email":123},"Bidhan Krishna Sarker, MSS","+88(0)1712729941","bidhan@icddrb.org",[125],{"facility":126,"status":86,"city":127,"state":128,"zip":86,"country":129,"countryCode":130,"cosmosGeoPoint":131,"geoPoint":136,"contacts":137},"World Vision Bangladesh","Purbadhala","Mymensingh","Bangladesh","BD",{"type":132,"coordinates":133},"Point",[134,135],90.60025,24.94077,{"lat":135,"lon":134},[138,142,146,149,151,153,155,157,159],{"name":139,"role":117,"phone":140,"phoneExt":86,"email":141},"Mezanur Rahman, MD","+88(0)1713490725","mdmezanur_rahman@wvi.org",{"name":143,"role":117,"phone":144,"phoneExt":86,"email":145},"Joyanta Nath, MD","+88(0)1714014833","joyanta_nath@wvi.org",{"name":147,"role":148,"phone":86,"phoneExt":86,"email":86},"Carmen Tse, MSc, HBSc","SUB_INVESTIGATOR",{"name":150,"role":148,"phone":86,"phoneExt":86,"email":86},"Miles Kirby, PhD",{"name":152,"role":148,"phone":86,"phoneExt":86,"email":86},"Iqbal Hossain, MBBS, DCH, PhD, FRCP",{"name":154,"role":148,"phone":86,"phoneExt":86,"email":86},"Md Tawhidur Rahman, MSS",{"name":156,"role":148,"phone":86,"phoneExt":86,"email":86},"A.B.M. Rasheduzzaman, MSS",{"name":158,"role":148,"phone":86,"phoneExt":86,"email":86},"Md. Golam Mustagir, MSc",{"name":160,"role":148,"phone":86,"phoneExt":86,"email":86},"Sadia Afrin, MSc",{"type":162,"investigatorFullName":86,"investigatorTitle":86,"investigatorAffiliation":86,"oldNameTitle":86,"oldOrganization":86},"SPONSOR",[164,166,168],{"name":165,"class":6},"London School of Hygiene and Tropical Medicine",{"name":167,"class":6},"International Centre for Diarrhoeal Disease Research, Bangladesh",{"name":169,"class":6},"World Vision","100639597",false,"NCT07591064","Effectiveness of Positive Deviance\u002FHearth in Treating Uncomplicated Moderate Acute Malnutrition in Children 6-59 Months in Mymensingh Division, Bangladesh","The Effectiveness of Positive Deviance\u002FHearth (PDH), a Local Dietary Approach, to Treat Uncomplicated Moderate Acute Malnutrition (MAM) in Children 6-59 Months in Mymensingh, Bangladesh","PD\u002FHearth MAM","Inclusion Criteria:\n\n* 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)\n* Children with MAM (WHZ\u002FWLZ \\\u003C-2 and ≥-3 and\u002For MUAC \\\u003C125mm and ≥115mm)\n* No Medical Complications (passes IMCI screening questions)\n* No oedema\n* Child does not deteriorate to SAM (WHZ\u002FWLZ\\\u003C-3 and\u002For MUAC\\\u003C115mm) because child should be referred to health centre\n* Caregiver refuses to receive age-appropriate immunization, Vitamin A and deworming minimum 2 weeks before PDH begins\n* Child is not planning to live outside the study area routinely for more than 2 weeks during the 3 months of the study\n* Written\u002FOral consent is given by Parent\u002FCaregiver to participate in the study\n\nExclusion Criteria:\n\n* Child is not between 6-52 months of age at Baseline\n* Child does not meet the inclusion criteria for WHZ\u002FWLZ and\u002For MUAC; (WHZ\u002FWLZ \\\u003C-2SD and ≥-3SD and\u002For MUAC \\\u003C125mm and ≥115mm);\n* Child has oedema;\n* Child has medical complications and\u002For does not pass the IMCI screening including fever, nausea\u002Fvomiting, acute respiratory illness (refer to Study Protocol V2.0, 19 Feb 2026);\n* Deteriorates to SAM and must be removed from the study and referred to the health centre for specially formulated food (SFF) treatment;\n* Refuses to receive minimum 2 weeks before the intervention begins, age-appropriate immunization and Vitamin A and deworming in the past 6 months;\n* 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\n* Parent\u002FCaregiver unable or unwilling to attend PDH from start;\n* Parent\u002FCaregiver does not provide written or oral consent to screen for the trial;\n* Parent\u002FCaregiver does not provide informed consent for the study; and\n* any other reason.",true,"ALL","6 Months","59 Months",{"count":182,"type":183},400,"ESTIMATED","INTERVENTIONAL",[186],"NA","The goal of this clinical trial (cluster randomized controlled trial) is to learn whether a Positive Deviance\u002FHearth (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:\n\n* Does the PDH intervention improve recovery rates among children with MAM?\n* Does the PDH intervention reduce relapse to MAM or progression to severe acute malnutrition (SAM) after recovery?\n\nResearchers 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.\n\nParticipants will:\n\n* Take part in a 12-day \"Hearth\" nutrition education program where caregivers prepare and feed children nutrient-dense meals using local foods\n* Receive 2 weeks of home follow-up visits by volunteers after the Hearth sessions, along with ongoing growth monitoring and counseling twice per month\n* Undergo periodic anthropometric assessments (weight, height\u002Flength, Mid-upper arm circumference (MUAC)) at key time points",[189,190,191],"Moderate Acute Malnutrition (MAM)","Undernutrition","Wasting",[193,194,195,196],"Moderate acute malnutrition (MAM)","Children","relapse","positive deviance\u002Fhearth","NOT_YET_RECRUITING","2026-05-08",{"date":200,"type":201},"2026-05-15","ACTUAL",{"date":203,"type":183},"2026-05-16",{"date":205,"type":183},"2026-12-17",{"name":5,"class":6},1]