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

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

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.

Study Overview

• Status: Completed
• Conditions: Severe Acute Malnutrition
• Intervention / Treatment: Other: Standard weekly visits; Other: Monthly visits

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 Type: Interventional
• Enrollment (Actual): 3945
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Sokoto, Nigeria
    • Sokoto State Nutrition Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard weekly visits; Standard weekly visits at the outpatient therapeutic feeding center until discharge	Other: Standard weekly visits; 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
Other: 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	Other: Monthly visits; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Epicentre
• Investigators: Study Director: Rebecca GRAIS, Epicentre

Publications and helpful links

General Publications

• Hitchings MDT, Berthe F, Aruna P, Shehu I, Hamza MA, Nanama S, Steve-Edemba C, Grais RF, Isanaka S. Effectiveness of a monthly schedule of follow-up for the treatment of uncomplicated severe acute malnutrition in Sokoto, Nigeria: A cluster randomized crossover trial. PLoS Med. 2022 Mar 1;19(3):e1003923. doi: 10.1371/journal.pmed.1003923. eCollection 2022 Mar.
• Isanaka S, Hedt-Gauthier BL, Salou H, Berthe F, Grais RF, Allen BGS. Active and adaptive case finding to estimate therapeutic program coverage for severe acute malnutrition: a capture-recapture study. BMC Health Serv Res. 2019 Dec 16;19(1):967. doi: 10.1186/s12913-019-4791-9.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2018
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): April 27, 2020

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 4, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Severe Acute Malnutrition
• Other Study ID Numbers: Reduced follow-up

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Subject to individual data sharing agreements

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No