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

Sponsor

Epicentre (Other)

Overall Status

Completed

CT.gov ID

NCT02994212

Collaborator

Médecins Sans Frontières, France (Other)

115

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Acute Malnutrition	Dietary Supplement: Monthly distribution of RUTF	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

115 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group 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 115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF.

Arm

Intervention/Treatment

Experimental: Intervention group

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

correct utilization of RUTF [4 weeks]
> 2 sachets deviance between available and expected RUTF stocks at unannounced household visits

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 59 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. being eligible for new admission to treatment of uncomplicated SAM
1. 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Epicentre
Médecins Sans Frontières, France

Investigators

Principal Investigator: Sheila Isanaka, ScD, Epicentre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Epicentre

ClinicalTrials.gov Identifier:

NCT02994212

Other Study ID Numbers:

821414-1

First Posted:

Dec 15, 2016

Last Update Posted:

Dec 4, 2019

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Malnutrition

Severe Acute Malnutrition

Study Results

No Results Posted as of Dec 4, 2019