Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition

The investigators propose a pilot randomized controlled trial to train mothers to screen their children post-discharge for relapse based on MUAC criteria to facilitate timely identification and referral to care for children who have relapsed.

Study Overview

• Status: Recruiting
• Conditions: Severe Acute Malnutrition
• Intervention / Treatment: Other: Mother education on how to perform MUAC assessment

Detailed Description

While interventions prioritizing rapid weight gain have led to improved survival for children with severe acute malnutrition (SAM), prevention of relapse to SAM after recovery is essential to improve long-term outcomes for children beyond survival. Mothers have been successfully trained to screen for new-onset SAM in community-based settings and perform as well as community health workers for detecting SAM. Here, the investigators propose a pilot randomized controlled trial in which mothers will be trained to screen their children post-discharge for relapse based on MUAC criteria to facilitate timely identification and referral to care for children who have relapsed.

SPECIFIC AIM 1: Determine the feasibility of training mothers to screen for relapse among children recovering from SAM compared to standard of care for early detection of relapse and re-entry to care. The investigators hypothesize that relapse will be detected earlier in children whose mothers have been trained to screen for relapse compared to standard of care (no mother screening).

Specific Aim 1A: Determine the burden of post-discharge relapse among children recovered from an episode of SAM in Boromo, Burkina Faso. The investigators hypothesize that >25% of children who have recovered from SAM in the study facilities will relapse within a 6-month period following their discharge.

Specific Aim 1B: Determine the acceptability and feasibility of training mothers to screen for relapse after discharge among children recovered from SAM. the investigators hypothesize that mothers will find MUAC screening acceptable and that training them will be feasible, as demonstrated by time and costs for training, willingness to participate in training, and follow-up in the trial.

SPECIFIC AIM 2: Determine the accuracy of mother-based screening for relapse among children recovering from SAM compared to a gold standard anthropometrist. the investigators hypothesize that mother screening will have a sensitivity and specificity of > 80% for the detection of relapsed SAM (MUAC < 11.5 cm) compared to screening by a trained anthropometrist.

the investigators anticipate that the result of this pilot will provide evidence supporting the acceptability, feasibility, and accuracy of mother screening for relapse among children with SAM. The data generated during this pilot will be used to support the development of a full-scale randomized controlled trial and will be used as preliminary data supporting an R01-level NIH application. These data will help establish a new line of work for our research team in the management of acute malnutrition, which builds on existing expertise in randomized controlled trials and antibiotic-based interventions for child survival and reduction of morbidity, including as part of the management of uncomplicated SAM.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine Oldenburg, ScD; Phone Number: 415-502-8843; Email: catherine.oldenburg@ucsf.edu
• Study Contact Backup: Name: Elodie Lebas, RN; Email: elodie.lebas@ucsf.edu

Study Locations

• Burkina Faso
  • Nouna, Burkina Faso
    • Recruiting
    • Centre de recherche en Santé de nouna
    • Contact: Ali Sie, MD, PHD; Phone Number: +226 70 20 47 78; Email: sieali@yahoo.fr
    • Contact: Mamadou Bountogo, MD, PHD; Phone Number: +226 70 39 89 44; Email: drbountogo@yahoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Caregiver's aged 18 years old or older or a legal guardian or a relative aged 18 or older
• Child aged 6-59 months

• Child has recovered from an episode of SAM per Burkinabè national guidelines (WHZ ≥

  • 2 and/or MUAC ≥ 12.5 cm in the past month
• Family is planning to stay in the study area for 6 months
• Appropriate consent from the caregiver or guardian

Exclusion Criteria:

• Caregiver age under 18 years old, or legal guardian or relatives under 18 years old
• Child age < 6 months or > 59 months
• Twins/multiple births and children with feeding issues
• Did not recover from SAM in the past month
• Family is planning to move out of the study area in the next 6 months
• Caregiver or guardian refuses to provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mother screening; In this arm, mothers / children dyads will be enrolled. Mothers will be trained to measure mid-upper arm circumference (MUAC) on their children weekly for 6 months. All other standard care will be provided.	Other: Mother education on how to perform MUAC assessment; Mothers will be trained to perform MUAC weekly on their children
No Intervention: standard of care; In this arm, mothers / children dyads will be enrolled. No study intervention will be performed. all other standard of care will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to detection of relapse	Time to relapse using a log-rank test with a term for randomized treatment assignment will be used. Relapse will be defined using the Burkina Faso guideline for detecting malnutrition (MUAC < 11.5 cm and / or weight-for-height Z-scores WHZ < -3 SD)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight for Height Z score (WHZ)	Weight for Height Z score will be calculated and compared between arms	6 months
weight-for-age Z-score (WAZ)	weight-for-age Z-score will be calculated and compared between arms	6 months
height-for-age Z-score (HAZ)	height-for-age Z-score will be calculated and compared between arms	6 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Centre de Recherche en Sante de Nouna, Burkina Faso
• Investigators: Principal Investigator: Catherine Oldenburg, ScD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Severe Acute Malnutrition
• Other Study ID Numbers: 23-38829

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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