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

Study Overview
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Brief Summary
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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.

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

Conditions
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Severe Acute Malnutrition

Intervention / Treatment
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* Dietary Supplement: Monthly distribution of RUTF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a) being eligible for new admission to treatment of uncomplicated SAM b) being resident within 15 km of the study health center 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)

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correct utilization of RUTF | > 2 sachets deviance between available and expected RUTF stocks at unannounced household visits | 4 weeks |