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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05932992
Enrollment
400
Registered
2023-07-06
Start date
2023-12-01
Completion date
2024-11-30
Last updated
2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Acute Malnutrition

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.

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.

Interventions

OTHERMother education on how to perform MUAC assessment

Mothers will be trained to perform MUAC weekly on their children

Sponsors

University of California, San Francisco
Lead SponsorOTHER
Centre de Recherche en Sante de Nouna, Burkina Faso
CollaboratorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Outcomes assessor and investigator will be masked to intervention. In regards to the intervention, participants and care providers won't be masked.

Intervention model description

Randomized controlled trial of mothers being trained to measure MUAC vs standard of care to prevent relapse

Eligibility

Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Time to Detection of Relapse6 monthsTime 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)

Secondary

MeasureTime frameDescription
Weight for Height Z Score (WHZ)6 monthsWeight-for-height Z-score (WHZ) is the number of standard deviations a child's weight-for-height differs from the median of the WHO Child Growth Standards reference population. A Z-score of 0 represents the reference population median. Higher WHZ values indicate better nutritional status, while lower values indicate greater wasting. WHZ below -2 SD indicates wasting, and WHZ below -3 SD indicates severe wasting/severe acute malnutrition. There is no fixed minimum or maximum value for this standardized Z-score.
Weight-for-age Z-score (WAZ)6 monthsWeight-for-age Z-score (WAZ) is the number of standard deviations a child's weight-for-age differs from the median of the WHO Child Growth Standards reference population. A Z-score of 0 represents the reference population median. Higher WAZ values indicate better nutritional status, while lower values indicate greater underweight. WAZ below -2 SD indicates underweight, and WAZ below -3 SD indicates severe underweight. There is no fixed minimum or maximum value for this standardized Z-score.
Height-for-age Z-score (HAZ)6 monthsHeight-for-age Z-score (HAZ) is the number of standard deviations a child's height-for-age differs from the median of the WHO Child Growth Standards reference population. A Z-score of 0 represents the reference population median. Higher HAZ values indicate better linear growth, while lower values indicate greater stunting. HAZ below -2 SD indicates stunting, and HAZ below -3 SD indicates severe stunting. There is no fixed minimum or maximum value for this standardized Z-score.

Countries

Burkina Faso

Contacts

PRINCIPAL_INVESTIGATORCatherine Oldenburg, ScD

University of California, San Francisco

Participant flow

Pre-assignment details

A total of 200 mother/caregiver-child dyads were enrolled, representing 400 individual participants: 200 mothers/caregivers and 200 children. The Protocol Enrollment number and Participant Flow milestones represent individual participants. Comments indicate the corresponding number of mothers/caregivers, children, and dyads for each milestone.

Baseline characteristics

Characteristic
Age, Continuous15 months
Caregiver age26 years
Caregiver education
College or above
3 Participants
Caregiver education
None
82 Participants
Caregiver education
Primary
21 Participants
Caregiver education
Secondary
6 Participants
Caregiver occupation
Agriculture
5 Participants
Caregiver occupation
Household
93 Participants
Caregiver occupation
Other
0 Participants
Caregiver occupation
Retail
3 Participants
Caregiver relationship
Grandmother
3 Participants
Caregiver relationship
Mother
98 Participants
Height-for-age Z-score (HAZ)-1.9 z-score
STANDARD_DEVIATION 1.4
Hemoglobin10.3 g/dL
Household dietary diversity was reported by the mother/caregiver and reflects household-level dietar10 units on a scale
Household food insecurity was reported by the mother/caregiver and reflects household-level food acc
Food secure
39 Participants
Household food insecurity was reported by the mother/caregiver and reflects household-level food acc
Mildly food insecure
18 Participants
Household food insecurity was reported by the mother/caregiver and reflects household-level food acc
Moderately food insecure
21 Participants
Household food insecurity was reported by the mother/caregiver and reflects household-level food acc
Severely food insecure
37 Participants
Mid-upper arm circumference (MUAC)13 cm
Number of children <5 years in household2 children in household
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
198 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
0 Participants
Region of Enrollment
Burkina Faso
400 participants
Sanitary installation
Improved pit latrine
13 Participants
Sanitary installation
Simple latrine with slab
83 Participants
Sanitary installation
Simple sand dale latrine
11 Participants
Sex: Female, Male
Female
43 Participants
Sex: Female, Male
Male
48 Participants
Water source
Other
1 Participants
Water source
Protected dug well
47 Participants
Water source
Running water or tubewell
53 Participants
Water source
Unprotected dug well
1 Participants
Weight-for-age Z-score (WAZ)-2.1 z-score
STANDARD_DEVIATION 0.9
Weight for Height Z Score (WHZ)-1.5 z-score
STANDARD_DEVIATION 0.8

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 994 / 101
other
Total, other adverse events
0 / 990 / 101
serious
Total, serious adverse events
3 / 999 / 101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026