Reduced Visit Frequency in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety

NCT02994212 | Completed

• 1 other identifier: 821414-1
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief Summary

Community-based management of severe acute malnutrition (SAM) has been shown to be safe and cost-effective, but program coverage remains low. New treatment models that maintain high levels of clinical effectiveness but allow for increased coverage are still needed. A reduced schedule of follow-up, in which children receive clinical follow-up and therapeutic foods on a monthly rather than weekly or biweekly basis, may be one alternative. This study aims to describe the safety and feasibility of a monthly distribution of ready-to-use therapeutic food in the treatment of uncomplicated SAM, in terms of clinical response to treatment and household ready-to-use therapeutic food (RUTF) utilization. This is a non-randomized pilot intervention study in which 115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis for 4 weeks to monitor treatment response defined as weight gain, (mid-upper arm circumference) MUAC gain, weight loss \> 5%, and the development of edema. Unannounced household spot checks were conducted over 4 weeks to assess household utilization of RUTF and storage practices.

Conditions

Severe Acute Malnutrition

Outcome Measures

Primary Outcomes (4)

• weight gain

  grams/kilograms/day gained

  4 weeks

• mid-upper arm circumference gain (mm/day)

  millimeters gained per day

  4 weeks

• weight loss > 5%

  4 weeks

• development of edema

  4 weeks

Secondary Outcomes (1)

• correct utilization of RUTF

  4 weeks

Study Arms (1)

Intervention group

EXPERIMENTAL

115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis for 4 weeks to monitor treatment response.

Dietary Supplement: Monthly distribution of RUTF

Interventions

Monthly distribution of RUTF DIETARY_SUPPLEMENT

115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF.

Intervention group

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• a) being eligible for new admission to treatment of uncomplicated SAM
• b) being resident within 15 km of the study health center

You may not qualify if:

• previously default from previous SAM treatment (e.g. missed 2 consecutive weekly visits)
• considered a relapse case (e.g. re-admitted within three months of previous discharge)

Sponsors & Collaborators

• Epicentre: lead
• Médecins Sans Frontières, France: collaborator

Related Publications (1)

• Isanaka S, Kodish SR, Berthe F, Alley I, Nackers F, Hanson KE, Grais RF. Outpatient treatment of severe acute malnutrition: response to treatment with a reduced schedule of therapeutic food distribution. Am J Clin Nutr. 2017 May;105(5):1191-1197. doi: 10.3945/ajcn.116.148064. Epub 2017 Apr 12.

  PMID: 28404577 DERIVED

MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Sheila Isanaka, ScD

  Epicentre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 15, 2016
• Study Start: July 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 4, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share