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

Not Applicable

Completed

• Conditions: Severe Acute Malnutrition
• Interventions: Dietary Supplement: Monthly distribution of RUTF

• Registration Number: NCT02994212
• Lead Sponsor: Epicentre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-15
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

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

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Exclusion Criteria

• 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	Monthly distribution of RUTF	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.

Primary Outcome Measures

Name	Time	Method
weight loss > 5%	4 weeks
weight gain	4 weeks	grams/kilograms/day gained
mid-upper arm circumference gain (mm/day)	4 weeks	millimeters gained per day
development of edema	4 weeks

Secondary Outcome Measures

Name	Time	Method
correct utilization of RUTF	4 weeks	\> 2 sachets deviance between available and expected RUTF stocks at unannounced household visits