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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02994212
Enrollment
115
Registered
2016-12-15
Start date
2014-07-31
Completion date
2014-11-30
Last updated
2019-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Acute Malnutrition

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.

Interventions

DIETARY_SUPPLEMENTMonthly distribution of RUTF

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

Sponsors

Médecins Sans Frontières, France
CollaboratorOTHER
Epicentre
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
weight gain4 weeksgrams/kilograms/day gained
mid-upper arm circumference gain (mm/day)4 weeksmillimeters gained per day
weight loss > 5%4 weeks
development of edema4 weeks

Secondary

MeasureTime frameDescription
correct utilization of RUTF4 weeks\> 2 sachets deviance between available and expected RUTF stocks at unannounced household visits

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026