NCT05932992

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

June 27, 2023

Last Update Submit

March 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Weight for Height Z score (WHZ)

    6 months

  • weight-for-age Z-score (WAZ)

    6 months

  • height-for-age Z-score (HAZ)

    6 months

Study Arms (2)

Mother screening

ACTIVE COMPARATOR

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

standard of care

NO INTERVENTION

In this arm, mothers / children dyads will be enrolled. No study intervention will be performed. all other standard of care will be provided.

Interventions

Mothers will be trained to perform MUAC weekly on their children

Mother screening

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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 ≥
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche en sante de nouna

Nouna, Burkina Faso

Location

Related Publications (2)

  • Bountogo M, Dah C, Ouedraogo M, Zerbo F, Kouanda I, Lebas E, Fetterman I, La Mons J, Burroughs H, Arnold BF, Sie A, Oldenburg CE. Caregiver Screening for Relapse Among Children Recently Recovered From Severe Acute Malnutrition: A Randomized Controlled Feasibility Trial. Matern Child Nutr. 2026 Mar;22(1):e70160. doi: 10.1111/mcn.70160.

  • Dah C, Kimfuema A, Bountogo M, Zerbo F, Ouedraogo M, Kouanda I, Fetterman I, Arnold BF, Lebas E, Sie A, Oldenburg CE. Training caregivers to screen for relapse among children who have recovered from severe acute malnutrition: study protocol for a feasibility trial. Pilot Feasibility Stud. 2026 Jan 13. doi: 10.1186/s40814-025-01752-z. Online ahead of print.

MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Catherine Oldenburg, ScD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Outcomes assessor and investigator will be masked to intervention. In regards to the intervention, participants and care providers won't be masked.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial of mothers being trained to measure MUAC vs standard of care to prevent relapse
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 6, 2023

Study Start

December 1, 2023

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations