Clinical trial NCT03647150: Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria
Official title: Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria (Hi-MAM Study): A Cluster-randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Centre for Global Child Health, Hospital for Sick Kids, Toronto, Canada
name: Department of Psychology, University of Tampere, Finland
name: Project Peanut Butter, Sierra Leone
First posted: 2018-08-27
Enrollment: 1322
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recovery from moderate acute malnutrition (MAM)
timeFrame: up to 12 weeks of treatment
Secondary outcomes:
measure: Participant survival rates
timeFrame: Duration of the study 24 weeks post-enrollment
measure: Participants deterioration to severe acute malnutrition(SAM)
timeFrame: Duration of the study 24 weeks post-enrollment
measure: Participants that remain or become underweight using weight for age z-score
timeFrame: 24 weeks post-enrollment
measure: Participants that remain or become Stunted
timeFrame: 24 weeks post-enrollment
measure: Participants that remain or become Wasted
timeFrame: 24 weeks post-enrollment
measure: Eye tracking performance for cognitive development
timeFrame: 24 weeks post enrollment
Other outcomes:
Locations:
city: Freetown
country: Sierra Leone
facility: Project Peanut Butter
Study officials:
affiliation: Washington University School of Medicine in St. Louis
name: Mark Manary, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Schofield C, Ashworth A. Why have mortality rates for severe malnutrition remained so high? Bull World Health Organ. 1996;74(2):223-9.
citation: 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.