Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria (Hi-MAM)

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

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Behavioral: Mother Care group; Drug: amoxicillin; Dietary supplement: Ready-to-use therapeutic food (RUTF)

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.

• Study Type: Interventional
• Enrollment (Actual): 1322
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sierra Leone
  • Freetown, Sierra Leone
    • Project Peanut Butter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Centre for Global Child Health, Hospital for Sick Kids, Toronto, Canada; Department of Psychology, University of Tampere, Finland; Project Peanut Butter, Sierra Leone
• Investigators: Principal Investigator: Mark Manary, MD, Washington University School of Medicine in St. Louis

Publications and helpful links

General Publications

• Joshua GE, Jadhav M, Bhaktaviziam A, Mokashi S. Mental retardation in children. II. Leucodystrophies. Indian Pediatr. 1974 Jan;11(1):53-9. No abstract available.
• Lenters LM, Wazny K, Webb P, Ahmed T, Bhutta ZA. Treatment of severe and moderate acute malnutrition in low- and middle-income settings: a systematic review, meta-analysis and Delphi process. BMC Public Health. 2013;13 Suppl 3(Suppl 3):S23. doi: 10.1186/1471-2458-13-S3-S23. Epub 2013 Sep 17.
• Chang CY, Trehan I, Wang RJ, Thakwalakwa C, Maleta K, Deitchler M, Manary MJ. Children successfully treated for moderate acute malnutrition remain at risk for malnutrition and death in the subsequent year after recovery. J Nutr. 2013 Feb;143(2):215-20. doi: 10.3945/jn.112.168047. Epub 2012 Dec 19.
• Maust A, Koroma AS, Abla C, Molokwu N, Ryan KN, Singh L, Manary MJ. Severe and Moderate Acute Malnutrition Can Be Successfully Managed with an Integrated Protocol in Sierra Leone. J Nutr. 2015 Nov;145(11):2604-9. doi: 10.3945/jn.115.214957. Epub 2015 Sep 30.
• Ekelund U, Ong KK, Linne Y, Neovius M, Brage S, Dunger DB, Wareham NJ, Rossner S. Association of weight gain in infancy and early childhood with metabolic risk in young adults. J Clin Endocrinol Metab. 2007 Jan;92(1):98-103. doi: 10.1210/jc.2006-1071. Epub 2006 Oct 10.
• Khara T, Mwangome M, Ngari M, Dolan C. Children concurrently wasted and stunted: A meta-analysis of prevalence data of children 6-59 months from 84 countries. Matern Child Nutr. 2018 Apr;14(2):e12516. doi: 10.1111/mcn.12516. Epub 2017 Sep 25.
• Schofield C, Ashworth A. Why have mortality rates for severe malnutrition remained so high? Bull World Health Organ. 1996;74(2):223-9.
• Lelijveld N, Godbout C, Krietemeyer D, Los A, Wegner D, Hendrixson DT, Bandsma R, Koroma A, Manary M. Treating high-risk moderate acute malnutrition using therapeutic food compared with nutrition counseling (Hi-MAM Study): a cluster-randomized controlled trial. Am J Clin Nutr. 2021 Sep 1;114(3):955-964. doi: 10.1093/ajcn/nqab137.

Helpful Links

• United Nations Department of Economic and Social Affairs, P.D. World Population Prospectus 2017. 2017
• WHO. IMCI chart booklet. 2014

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2018
• Primary Completion (Actual): June 5, 2020
• Study Completion (Actual): June 5, 2020

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 29, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Anti-Infective Agents; Anti-Bacterial Agents; Amoxicillin
• Other Study ID Numbers: 201807153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No