Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria

Study Overview
=================
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.

Official Title
-----------------
Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria (Hi-MAM Study): A Cluster-randomized Controlled Trial Protocol

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Drug: amoxicillin
* Dietary Supplement: Ready-to-use therapeutic food (RUTF)
* Behavioral: Mother Care group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: uncomplicated MAM (based on MUAC equal to or greater than 11.5 cm and <12.5) Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Moderate Acute Malnutrition (MAM)<br>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. | Behavioral: Mother Care group<br>* Nutrition education via mother care groups lead by a respected elder in the local community<br>|
| Experimental: High Risk Moderate Acute Malnutrition (MAM)<br>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. | Drug: amoxicillin<br>* At enrollment the child will receive a 1 week course of amoxicillin<br>Dietary Supplement: Ready-to-use therapeutic food (RUTF)<br>* 1 sachet RUTF per day (508 calories) till child MUAC is greater than 12.4 cm or 12 weeks have elapsed<br>Behavioral: Mother Care group<br>* Nutrition education via mother care groups lead by a respected elder in the local community<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery from moderate acute malnutrition (MAM) | 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. | up to 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant survival rates | Proportion of participants survival rates during the study | Duration of the study 24 weeks post-enrollment | 
| Participants deterioration to severe acute malnutrition(SAM) | 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. | Duration of the study 24 weeks post-enrollment | 
| Participants that remain or become underweight using weight for age z-score | the difference between the weight for age z-score(WAZ) from enrollment to 24 weeks post-enrollment | 24 weeks post-enrollment | 
| Participants that remain or become Stunted | the difference between length for age z-score(LAZ) from enrollment to 24 weeks post enrollment | 24 weeks post-enrollment | 
| Participants that remain or become Wasted | the difference between weight for length z-score(WHL) from enrollment to 24 weeks post enrollment | 24 weeks post-enrollment | 
| Eye tracking performance for cognitive development | the difference between the eye tracking performance from enrollment to 24 weeks post enrollment | 24 weeks post enrollment |