World Vision Bangladesh
Purbadhala, Mymensingh, Bangladesh
NCT Number: NCT07591064
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
Trial opening soon.
Get Notified6 month–59 month
All sexes
Interventional
Not applicable
Purbadhala, Mymensingh, Bangladesh
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Children will receive basic health and nutrition services, including infant and young child feeding counselling.
Time frame: 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.
Time frame: 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".
Time frame: 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).
Time frame: At end of treatment at 3 months
Average WAZ
Time frame: At the end of treatment at 3 months
Average MUAC (mm)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to end of treatment at 3 months.
Child meets WHO MDD definition (fed 5 out of 8 food groups)
Time frame: From enrollment to end of treatment at 3 months.
Meets minimum meal frequency standard
Time frame: From enrollment to end of treatment at 3 months.
Meets combined MDD + meal frequency
Time frame: From enrollment to end of treatment at 3 months.
Consumption of unhealthy foods/beverages; Yes to any of the questions of eating unhealth foods
Time frame: From enrollment to end of treatment at 3 months.
Presence of illness (e.g., diarrhea, fever, ARI)
Time frame: From enrollment to end of treatment at 3 months.
Care sought for illness episode at health centre or hospital
Time frame: From enrollment to end of treatment at 3 months.
Reporting of washing hands at all 5 critical time points.
Time frame: From enrollment to end of treatment at 3 months.
Caregiver mental health or wellbeing score
Time frame: From enrollment to six months.
To assess the cost-effectiveness of PDH, taking into the costs of program design, implementation, and caregiver time.
Time frame: From enrollment to end of treatment at 3 months
Change in WHZ/WLZ z-score
Time frame: 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.
Time frame: From enrollment to end of treatment at 3 months
Change in WAZ
Time frame: From enrollment to end of treatment at 3 months
Change in HAZ/LAZ
Trial opening soon.
Get NotifiedWorld Vision US
Other
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
Acronym: PD/Hearth MAM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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