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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anemia; Malnutrition, Child; Malnutrition, Infant; Hemoglobin Level Measurement; Malnutrition or Risk of Malnutrition
• Intervention / Treatment: Behavioral: Training caregivers to screen children for malnutrition relapse; Other: Reduced follow-up schedule

Detailed Description

A pilot randomized controlled trial for MAMAN was conducted to find if training caregivers to perform mid-upper arm circumference measurements to screen for malnutrition is feasible. This research will be expanded by assessing caregiver screening for detection of moderate acute malnutrition or severe acute malnutrition relapse with a 1:1:1 randomized controlled trial enrolling caregiver-child dyads of an increased sample size of 1200 dyads, totaling 2400 individuals. This study will address the need for evidence of the effectiveness of caregiver administered mid-upper arm circumference screening in the improvement of outcomes for children who have recovered from severe acute malnutrition. The effectiveness of training caregivers to screen for child malnutrition relapse using mid-upper arm circumference tapes, risk of relapse, speed of relapse detection, and anthropometric outcomes of the children will be analyzed. This will assist in providing evidence to incorporate the routine inclusion of mid-upper arm circumference screening training for all caregivers of children who are being discharged from severe acute malnutrition treatment.

SPECIFIC AIM 1: Determine the effectiveness of training caregivers to screen for relapse to moderate acute malnutrition or severe acute malnutrition using mid-upper arm circumference tapes following recovery from severe acute malnutrition for improving anthropometric outcomes and improving time to relapse detection. It is hypothesized that caregiver screening will be effective for reducing time to detection of relapse and that children receiving caregiver screening will have better anthropometric measures at 6 months post recovery and faster time to detection of relapse among those who relapse.

• Specific Aim 1A: Determine if detection of relapse in children who have recently recovered from severe acute malnutrition is more expeditious when caregivers are trained to screen for relapse to moderate acute malnutrition or severe acute malnutrition using mid-upper arm circumference tapes compared to current standard of care. It is hypothesized that a reduction in time to relapse detection will occur when caregivers are trained to screen for relapse to moderate acute malnutrition or severe acute malnutrition using mid-upper arm circumference tapes.
• Specific Aim 1B: Determine the effectiveness of caregivers screening mid-upper arm circumference measurements on improving anthropometric outcomes for children. It is hypothesized that training for caregiver screening of mid-upper arm circumference will lead to earlier intervention and improved anthropometric outcomes for children at 12 months post-admission.

SPECIFIC AIM 2: Determine the acceptability caregiver mid-upper arm circumference training. It is hypothesized that most survey responses at the 3 and 6-month visits will show high levels of acceptance towards caregiver screening of children using mid-upper arm circumference tapes.

• Study Type: Interventional
• Enrollment (Estimated): 2400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine Oldenburg, ScD; Phone Number: 415-502-8843; Email: catherine.oldenburg@uscf.edu
• Study Contact Backup: Name: Hadley Burroughs; Email: hadley.burroughs@ucsf.edu

Study Locations

• Burkina Faso
  • Nouna, Burkina Faso
    • Recruiting
    • Centre de Recherche en Sante 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 6-54 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care treatment and follow-up schedule without alteration (control arm); 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.
Experimental: Caregiver mid-upper arm circumference (MUAC) screening and a standard of care follow-up schedule; 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; 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.; Other Names: Caregiver and/or mother mid-upper arm circumference screening
Experimental: Caregiver mid-upper arm circumference (MUAC) screening and a reduced follow-up schedule; 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; 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.; Other Names: Caregiver and/or mother mid-upper arm circumference screening; Other: Reduced follow-up schedule; 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.; Other Names: Reduced clinic visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to detection of relapse	The amount of time until the detection of malnutrition relapse will be assessed as a secondary outcome and will be defined as the time from the baseline visit until the planned or unplanned visit when malnutrition relapse is detected. This will be measured up until the 6 month visit and will be assessed by randomized study assignment.	6 months
Cumulative incidence of relapse to MAM or SAM separately	The proportion of children by randomized allocation who relapse to MAM or to SAM analyzed separately.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory: Longer-term endpoints	Children enrolled in the parent trial will be followed and assessed for relapse up to 12 months post-admission to the nutritional program. Using existing AMOUR study visits at 12 months post-admission (8-9 months post-recovery), relapse and anthropometric endpoints will be assessed.	12 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Thrasher Research Fund; 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): March 20, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: malnutrition; MUAC (mid-upper arm circumference); Caregiver screening; home based malnutrition screening
• Additional Relevant MeSH Terms: Nutrition Disorders; Hematologic Diseases; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Malnutrition; Anemia; Child Nutrition Disorders; Infant Nutrition Disorders
• Other Study ID Numbers: 24-42418

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