Reduced Visit Frequency in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety
December 3, 2019 updated by: Epicentre
Reduced Frequency of Visits in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
115
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
weight gain
Time Frame: 4 weeks
|
grams/kilograms/day gained
|
4 weeks
|
|
mid-upper arm circumference gain (mm/day)
Time Frame: 4 weeks
|
millimeters gained per day
|
4 weeks
|
|
weight loss > 5%
Time Frame: 4 weeks
|
4 weeks
|
|
|
development of edema
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
correct utilization of RUTF
Time Frame: 4 weeks
|
> 2 sachets deviance between available and expected RUTF stocks at unannounced household visits
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sheila Isanaka, ScD, Epicentre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
December 13, 2016
First Submitted That Met QC Criteria
December 13, 2016
First Posted (Estimate)
December 15, 2016
Study Record Updates
Last Update Posted (Actual)
December 4, 2019
Last Update Submitted That Met QC Criteria
December 3, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 821414-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.