Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria
- Conditions
- Malnutrition
- Interventions
- Behavioral: Mother Care groupDietary Supplement: Ready-to-use therapeutic food (RUTF)
- Registration Number
- NCT03647150
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
This project explores whether children have better growth and cognitive development when the clinic identifies "higher risk" MAM children and support them either with the same treatment as SAM children or with the recommended practice: nutrition counseling.
- Detailed Description
This is a cluster-randomized controlled trial taking place in 20 community clinics providing malnutrition care in Sierra Leone.
All participants will be children aged 6-59 months. Control participants will have moderate acute malnutrition (MAM), defined as mid-upper arm circumference (MUAC) 11.5-\<12.5. High Risk MAM will be defined with a MUAC 11.5 to \<11.9 or WAZ\<-3.5 or Mother not the caretaker or not breastfeeding at \<2 years old. Low risk MAM defined with a MUAC 11.9 to \<12.5 with no risk factors.
Control group and low risk group caregiver's will received nutrition education via mother care groups every two weeks for 6 weeks and will be followed up 12 and 24 weeks post-enrollment.
High risk group will receive 1 week supply of amoxicillin at enrollment and 1 sachet of RUTF per day till MUAC is equal to or greater than 12.5 or up to 12 weeks of treatment. Their caregiver will also receive nutrition education via the mother care groups. The investigators will also follow up with the participant at 12 and 24 weeks post-enrollment.
A subset of the participants in each group will also be enrolled in a cognitive development substudy were the investigators will be using a eye tracking performance assessment. Investigators will also enroll health adult participants for eye tracking assessment. Adult data will be used as a reference when interpreting results.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1322
- uncomplicated MAM (based on MUAC equal to or greater than 11.5 cm and <12.5)
- currently involved in another research trial or feeding program
- medical complication such as oedema, severe nausea/vomiting, severe dehydration, or severe pneumonia
- have a diagnosed or visible sign of developmental delay
- have a history of peanut or milk allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moderate Acute Malnutrition (MAM) Mother Care group MAM children at control clinics or MAM children at intervention clinics that do no have high rick characteristics. Control treatment is "Mother Care" counselling, delivered by a respected elder in the local community. High Risk Moderate Acute Malnutrition (MAM) Ready-to-use therapeutic food (RUTF) The intervention treatment incorporates Mother Care counselling, provision of one packet (508 calories) of ready-to-use therapeutic food (RUTF) daily and a 1 week course of amoxicillin. This provision will continue until the child has reached a mid-upper arm circumference (MUAC) equal to or greater than 12.5 cm or 12 weeks have elapsed. High Risk Moderate Acute Malnutrition (MAM) Mother Care group The intervention treatment incorporates Mother Care counselling, provision of one packet (508 calories) of ready-to-use therapeutic food (RUTF) daily and a 1 week course of amoxicillin. This provision will continue until the child has reached a mid-upper arm circumference (MUAC) equal to or greater than 12.5 cm or 12 weeks have elapsed. High Risk Moderate Acute Malnutrition (MAM) amoxicillin The intervention treatment incorporates Mother Care counselling, provision of one packet (508 calories) of ready-to-use therapeutic food (RUTF) daily and a 1 week course of amoxicillin. This provision will continue until the child has reached a mid-upper arm circumference (MUAC) equal to or greater than 12.5 cm or 12 weeks have elapsed.
- Primary Outcome Measures
Name Time Method Recovery from moderate acute malnutrition (MAM) up to 12 weeks of treatment proportion of participants recovered based on mid-upper arm circumference(MUAC) Recovery is defined as MUAC greater than or equal to 12.5cm before or at 12 weeks after enrollment.
- Secondary Outcome Measures
Name Time Method Participants that remain or become Stunted 24 weeks post-enrollment the difference between length for age z-score(LAZ) from enrollment to 24 weeks post enrollment
Participants deterioration to severe acute malnutrition(SAM) Duration of the study 24 weeks post-enrollment Proportion of participants that deteriorate from moderate acute malnutrition(MAM) to severe acute malnutrition(SAM). SAM is defined at mid-upper arm circumference(MUAC)\<11.5 or presence of oedema.
Eye tracking performance for cognitive development 24 weeks post enrollment the difference between the eye tracking performance from enrollment to 24 weeks post enrollment
Participant survival rates Duration of the study 24 weeks post-enrollment Proportion of participants survival rates during the study
Participants that remain or become underweight using weight for age z-score 24 weeks post-enrollment the difference between the weight for age z-score(WAZ) from enrollment to 24 weeks post-enrollment
Participants that remain or become Wasted 24 weeks post-enrollment the difference between weight for length z-score(WHL) from enrollment to 24 weeks post enrollment
Trial Locations
- Locations (1)
Project Peanut Butter
🇸🇱Freetown, Sierra Leone