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

Not Applicable

Completed

• Conditions: Severe Acute Malnutrition
• Interventions: Other: Standard weekly visits; Other: Monthly visits

• Registration Number: NCT03140904
• Lead Sponsor: Epicentre

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-04-28
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-04
• Study Start: 2018-01-23
• Primary Completion: 2019-11-30
• Study Completion: 2020-04-27
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-11
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3945

Inclusion Criteria

• age from 6 to 59 months
• MUAC < 115 mm and/or grade 1-2 edema
• Absence of current illness requiring inpatient care

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard weekly visits	Standard weekly visits	Standard weekly visits at the outpatient therapeutic feeding center until discharge
Monthly visits	Monthly visits	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

Primary Outcome Measures

Name	Time	Method
Nutritional recovery	Minimum length of stay is 8 weeks	Defined by being free from medical complications, MUAC \> 125 mm, and no edema for 2 weeks if admitted with edema

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sokoto State Nutrition Centre; 🇳🇬 Sokoto, Nigeria