Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition (Full Scale Trial)

NCT06599580 | Recruiting DMC

• 1 other identifier: 24-42418
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief Summary

A 1:1:1 individually randomized unmasked controlled trial is proposed in which caregivers will be trained to screen their children who have recovered from an episode of SAM (severe acute malnutrition) using MUAC (mid-upper arm circumference) tapes. One arm will include caregiver screening with a mid-upper arm circumference tape and usual monthly follow-up schedule for the first 3 months post enrollment and a final follow-up at 6 months. Another arm will include caregiver screening with a mid-upper arm circumference tape and a reduced follow-up schedule for one visit at 3 months and a final visit at 6 months. The third arm will adhere to the current standard of care, which is no caregiver training to conduct mid-upper arm circumference screenings and monthly clinic-based follow-up appointments for 3 months with a final visit at 6 months post enrollment. Children aged 6-54 months with a documented recovery from uncomplicated severe acute malnutrition that was managed in a participating outpatient nutritional program and their caregivers will be eligible for inclusion in the trial. Caregivers will be trained to screen their children weekly for 6 months following discharge from the nutritional program and will be counseled to bring their child back to the nutritional program should their mid-upper arm circumference value fall in the red zone of the mid-upper arm circumference tape (\< 11.5 cm). All children will be seen at 3 and 6 months for the primary outcome assessment. By conducting this study, our primary goal is to determine if training caregivers to screen their children for relapse to MAM (moderate acute malnutrition) or SAM (severe acute malnutrition) using mid-upper arm circumference tapes following recovery from SAM (severe acute malnutrition) will reduce the risk of relapse. An additional aim is to assess the level of acceptability of caregivers screening children for malnutrition using mid-upper arm circumference tapes from both a clinic and caregiver perspective.

Conditions

Malnutrition, Child; Malnutrition, Infant; Malnutrition or Risk of Malnutrition; Hemoglobin Level Measurement; Anemia

Keywords

MUAC (mid-upper arm circumference); Caregiver screening; malnutrition; home based malnutrition screening

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of relapse

  The primary outcome will be defined as the proportion of children who relapse to global acute malnutrition (either moderate acute malnutrition with mid-upper arm circumference \< 12.5 cm to ≥ 11.5 cm and/or weight-for-height Z score \< -2 to ≥ -3 or severe acute malnutrition with mid-upper arm circumference \< 11.5 cm and/or weight-for-height Z score \< -3) by the 6 month primary endpoint randomized by study assignment.

  6 months

Secondary Outcomes (2)

• Time to detection of relapse

  6 months

• Cumulative incidence of relapse to MAM or SAM separately

  6 months

Study Arms (3)

Standard of care treatment and follow-up schedule without alteration (control arm)

NO INTERVENTION

This arm with serve as the control arm and receive the current standard of care, which is no caregiver training to conduct mid-upper arm circumference screenings and monthly clinic-based follow-up appointments for 3 months with a final visit at 6 months post enrollment.

Caregiver mid-upper arm circumference (MUAC) screening and a standard of care follow-up schedule

EXPERIMENTAL

This arm will include caregiver screening with a mid-upper arm circumference tape at home weekly. Caregivers will be trained to screen their child for malnutrition relapse using mid-upper arm circumference tapes and requested to bring their child back to the clinic when relapse is detected. Additionally, this arm will receive the standard of care, which includes a monthly follow-up schedule for the first 3 months post enrollment and a final follow-up at 6 months.

Behavioral: Training caregivers to screen children for malnutrition relapse

Caregiver mid-upper arm circumference (MUAC) screening and a reduced follow-up schedule

EXPERIMENTAL

This arm will include caregiver screening with a mid-upper arm circumference tape at home weekly. Caregivers will be trained to screen their child for malnutrition relapse using mid-upper arm circumference tapes and requested to bring their child back to the clinic when relapse is detected. Additionally, this arm will receive a reduced follow-up schedule at the clinic, which will include one planned visit at 3 months post enrollment and a final follow-up visit at 6 months.

Behavioral: Training caregivers to screen children for malnutrition relapse; Other: Reduced follow-up schedule

Interventions

Training caregivers to screen children for malnutrition relapse BEHAVIORAL

Caregivers enrolled in the trial who are assigned to the two experimental arms, will be provided mid-upper arm circumference tapes and trained on how to screen their child for malnutrition relapse and asked to bring their child back to the clinic if relapse is detected.

Also known as: Caregiver and/or mother mid-upper arm circumference screening

Caregiver mid-upper arm circumference (MUAC) screening and a reduced follow-up schedule; Caregiver mid-upper arm circumference (MUAC) screening and a standard of care follow-up schedule

Reduced follow-up schedule OTHER

Caregivers in one of the caregiver mid-upper arm circumference screening arms, will be asked to adhere to a reduced follow-up clinic visit schedule for when they bring their child to the clinic for planned visits. The standard of care includes monthly visits for the first 3 months post recovery, but those randomized to the reduced follow-up schedule arm, will not bring their child to the clinic for planned visits 1 month and 2 months after baseline.

Also known as: Reduced clinic visits

Caregiver mid-upper arm circumference (MUAC) screening and a reduced follow-up schedule

Eligibility Criteria

• Age: 6 Months - 54 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (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 6-54 months
• Child has recovered from an episode of severe acute malnutrition per Burkinabè national guidelines (weight-for-height ≥ -2 and/or mid-upper arm circumference ≥ 12.5 cm in the past month, with the criterion used for admissions corresponding to the original admission criteria)
• 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 \> 54 months
• Twins/multiple births
• Children with feeding issues
• Did not recover from severe acute malnutrition 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Centre de Recherche en Sante de Nouna, Burkina Faso: collaborator
• Thrasher Research Fund: collaborator

Study Sites (1)

Centre de recherche en sante de nouna

Nouna, Burkina Faso

RECRUITING

MeSH Terms

Conditions

Child Nutrition Disorders; Infant Nutrition Disorders; Malnutrition; Anemia

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Catherine Oldenburg, ScD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Oldenburg, ScD

CONTACT

415-502-8843; catherine.oldenburg@uscf.edu

Hadley Burroughs

CONTACT

hadley.burroughs@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: March 20, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)