Reducing the Frequency of Follow up and Task Sharing in the Treatment of Uncomplicated Severe Acute Malnutrition

Study Overview
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Brief Summary
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This study will be conducted as a stratified cluster randomized trial. The unit of randomization will be the outpatient therapeutic feeding center. The 10 health centers will be stratified by size, and centers within a stratum will be randomized in a 1:1 ratio to one of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support for home-based surveillance.

Detailed Description
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This study will be conducted as a stratified cluster randomized trial of a monthly schedule of follow up in the treatment of uncomplicated SAM among children aged 6 to 59 months. The unit of randomization will be the outpatient therapeutic feeding center. The 10 health centers supported by International Medical Corps UK (IMC-UK) will be stratified by size (± 1000 admissions per site per year), and centers within a stratum will be randomized in a 1:1 ratio to one of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support for home-based surveillance. Distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a weekly or monthly basis until discharge according to the random assignment of the site. Caregivers in the monthly visit group will receive additional instruction at admission regarding home-based MUAC measurement and clinical surveillance. Regardless of intervention assignment, all children with uncomplicated SAM will receive standard medical care on admission as per national guidelines, and a home visit 2 months following discharge from the nutritional program. Additional data collection, including coverage assessment and economic costing analysis will be used to address the secondary objectives related to the evaluation of coverage and cost-effectiveness, respectively.

Official Title
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Reducing the Frequency of Follow up and Task Sharing in the Treatment of Uncomplicated Severe Acute Malnutrition: an Evaluation of Monthly Visits and Home-based Surveillance for Access-limited and High-burden Settings

Conditions
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Severe Acute Malnutrition

Intervention / Treatment
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* Other: Standard weekly visits
* Other: Monthly visits


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age from 6 to 59 months MUAC < 115 mm and/or grade 1-2 edema Absence of current illness requiring inpatient care Exclusion Criteria: History of allergy to peanuts Any other condition in which, in the judgment of the Field Investigator, would interfere with or serves as a contraindication to protocol adherence or the ability to give informed consent

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

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Standard weekly visits at the outpatient therapeutic feeding center until discharge Monthly visits at the outpatient therapeutic feeding center with caregiver support for home-based surveillance, with visits scheduled at weeks 4, 8, 10 and 12 until discharge.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard weekly visits<br>Standard weekly visits at the outpatient therapeutic feeding center until discharge | Other: Standard weekly visits<br>* Distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a weekly basis at the outpatient therapeutic feeding center according to the random assignment of the site, until discharge<br>|
| Other: Monthly visits<br>Monthly visits at the outpatient therapeutic feeding center with caregiver support for home-based surveillance, with visits scheduled at weeks 4, 8, 10 and 12 until discharge | Other: Monthly visits<br>* Distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a monthly basis at the outpatient therapeutic feeding center according to the random assignment of the site, until discharge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional recovery | Defined by being free from medical complications, MUAC > 125 mm, and no edema for 2 weeks if admitted with edema | Minimum length of stay is 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization | Hospitalization, defined as referral to inpatient care for weight/edema change, or failed appetite test, clinical complication necessitating inpatient care | within 2 months | 
| Daily weight gain (g / kg / day) among recovered children | difference in weight (g) | within 2 months | 
| Defaulting | 3 missed scheduled facility visits in the weekly follow-up group and 1 missed scheduled facility visit in the monthly follow-up group | within 2 months | 
| Relapse | Maternal report of admission to any therapeutic feeding program | Within 2 months |