Trial Outcomes & Findings for Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition (NCT NCT05932992)
NCT ID: NCT05932992
Last Updated: 2026-07-17
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
400 participants
Primary outcome timeframe
6 months
Results posted on
2026-07-17
Participant Flow
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.
Participant milestones
| Measure |
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.
Mother education on how to perform MUAC assessment: Mothers will be trained to perform MUAC weekly on their children
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
198
|
202
|
|
Overall Study
COMPLETED
|
186
|
180
|
|
Overall Study
NOT COMPLETED
|
12
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Child's age.
Baseline characteristics by cohort
| Measure |
Mother Screening
n=198 Participants
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.
Mother education on how to perform MUAC assessment: Mothers will be trained to perform MUAC weekly on their children
|
Standard of Care
n=202 Participants
In this arm, mothers / children dyads will be enrolled. No study intervention will be performed. all other standard of care will be provided.
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14 months
n=99 Participants • Child's age.
|
15 months
n=101 Participants • Child's age.
|
14.5 months
n=200 Participants • Child's age.
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants • Child's sex.
|
53 Participants
n=101 Participants • Child's sex.
|
96 Participants
n=200 Participants • Child's sex.
|
|
Sex: Female, Male
Male
|
56 Participants
n=99 Participants • Child's sex.
|
48 Participants
n=101 Participants • Child's sex.
|
104 Participants
n=200 Participants • Child's sex.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=198 Participants
|
0 Participants
n=202 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=198 Participants
|
0 Participants
n=202 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=198 Participants
|
0 Participants
n=202 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Black or African American
|
198 Participants
n=198 Participants
|
202 Participants
n=202 Participants
|
400 Participants
n=400 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=198 Participants
|
0 Participants
n=202 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=198 Participants
|
0 Participants
n=202 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=198 Participants
|
0 Participants
n=202 Participants
|
0 Participants
n=400 Participants
|
|
Region of Enrollment
Burkina Faso
|
198 participants
n=198 Participants
|
202 participants
n=202 Participants
|
400 participants
n=400 Participants
|
|
Mid-upper arm circumference (MUAC)
|
13 cm
n=99 Participants • Child's MUAC.
|
13.1 cm
n=101 Participants • Child's MUAC.
|
13 cm
n=200 Participants • Child's MUAC.
|
|
Weight for Height Z Score (WHZ)
|
-1.5 z-score
STANDARD_DEVIATION 0.8 • n=99 Participants • Child's WHZ.
|
-1.6 z-score
STANDARD_DEVIATION 0.8 • n=101 Participants • Child's WHZ.
|
-1.5 z-score
STANDARD_DEVIATION 0.8 • n=200 Participants • Child's WHZ.
|
|
Weight-for-age Z-score (WAZ)
|
-2.1 z-score
STANDARD_DEVIATION 0.8 • n=99 Participants • Child's WAZ.
|
-2.1 z-score
STANDARD_DEVIATION 0.9 • n=101 Participants • Child's WAZ.
|
-2.1 z-score
STANDARD_DEVIATION 0.9 • n=200 Participants • Child's WAZ.
|
|
Height-for-age Z-score (HAZ)
|
-1.9 z-score
STANDARD_DEVIATION 1.5 • n=99 Participants • Child's HAZ.
|
-1.8 z-score
STANDARD_DEVIATION 1.4 • n=101 Participants • Child's HAZ.
|
-1.9 z-score
STANDARD_DEVIATION 1.4 • n=200 Participants • Child's HAZ.
|
|
Hemoglobin
|
10.2 g/dL
n=99 Participants • Child's hemoglobin level.
|
10.4 g/dL
n=101 Participants • Child's hemoglobin level.
|
10.3 g/dL
n=200 Participants • Child's hemoglobin level.
|
|
Household dietary diversity was reported by the mother/caregiver and reflects household-level dietar
|
11 units on a scale
n=99 Participants • Household dietary diversity score.
|
10 units on a scale
n=101 Participants • Household dietary diversity score.
|
10 units on a scale
n=200 Participants • Household dietary diversity score.
|
|
Caregiver relationship
Mother
|
98 Participants
n=99 Participants • Caregiver's relationship to child.
|
98 Participants
n=101 Participants • Caregiver's relationship to child.
|
196 Participants
n=200 Participants • Caregiver's relationship to child.
|
|
Caregiver relationship
Grandmother
|
1 Participants
n=99 Participants • Caregiver's relationship to child.
|
3 Participants
n=101 Participants • Caregiver's relationship to child.
|
4 Participants
n=200 Participants • Caregiver's relationship to child.
|
|
Caregiver age
|
24 years
n=99 Participants • Caregiver's age.
|
26 years
n=101 Participants • Caregiver's age.
|
25 years
n=200 Participants • Caregiver's age.
|
|
Caregiver education
None
|
70 Participants
n=99 Participants • Caregiver's education.
|
82 Participants
n=101 Participants • Caregiver's education.
|
152 Participants
n=200 Participants • Caregiver's education.
|
|
Caregiver education
Primary
|
21 Participants
n=99 Participants • Caregiver's education.
|
11 Participants
n=101 Participants • Caregiver's education.
|
32 Participants
n=200 Participants • Caregiver's education.
|
|
Caregiver education
Secondary
|
5 Participants
n=99 Participants • Caregiver's education.
|
6 Participants
n=101 Participants • Caregiver's education.
|
11 Participants
n=200 Participants • Caregiver's education.
|
|
Caregiver education
College or above
|
3 Participants
n=99 Participants • Caregiver's education.
|
2 Participants
n=101 Participants • Caregiver's education.
|
5 Participants
n=200 Participants • Caregiver's education.
|
|
Caregiver occupation
Household
|
85 Participants
n=99 Participants • Caregiver's occupation.
|
93 Participants
n=101 Participants • Caregiver's occupation.
|
178 Participants
n=200 Participants • Caregiver's occupation.
|
|
Caregiver occupation
Agriculture
|
9 Participants
n=99 Participants • Caregiver's occupation.
|
5 Participants
n=101 Participants • Caregiver's occupation.
|
14 Participants
n=200 Participants • Caregiver's occupation.
|
|
Caregiver occupation
Retail
|
3 Participants
n=99 Participants • Caregiver's occupation.
|
3 Participants
n=101 Participants • Caregiver's occupation.
|
6 Participants
n=200 Participants • Caregiver's occupation.
|
|
Caregiver occupation
Other
|
2 Participants
n=99 Participants • Caregiver's occupation.
|
0 Participants
n=101 Participants • Caregiver's occupation.
|
2 Participants
n=200 Participants • Caregiver's occupation.
|
|
Number of children <5 years in household
|
2 children in household
n=99 Participants • Number of children the caregiver has.
|
2 children in household
n=101 Participants • Number of children the caregiver has.
|
2 children in household
n=200 Participants • Number of children the caregiver has.
|
|
Household food insecurity was reported by the mother/caregiver and reflects household-level food acc
Food secure
|
39 Participants
n=99 Participants • Household food insecurity.
|
34 Participants
n=101 Participants • Household food insecurity.
|
73 Participants
n=200 Participants • Household food insecurity.
|
|
Household food insecurity was reported by the mother/caregiver and reflects household-level food acc
Mildly food insecure
|
18 Participants
n=99 Participants • Household food insecurity.
|
25 Participants
n=101 Participants • Household food insecurity.
|
43 Participants
n=200 Participants • Household food insecurity.
|
|
Household food insecurity was reported by the mother/caregiver and reflects household-level food acc
Moderately food insecure
|
26 Participants
n=99 Participants • Household food insecurity.
|
21 Participants
n=101 Participants • Household food insecurity.
|
47 Participants
n=200 Participants • Household food insecurity.
|
|
Household food insecurity was reported by the mother/caregiver and reflects household-level food acc
Severely food insecure
|
16 Participants
n=99 Participants • Household food insecurity.
|
21 Participants
n=101 Participants • Household food insecurity.
|
37 Participants
n=200 Participants • Household food insecurity.
|
|
Water source
Running water or tubewell
|
53 Participants
n=99 Participants • Household's water source.
|
53 Participants
n=101 Participants • Household's water source.
|
106 Participants
n=200 Participants • Household's water source.
|
|
Water source
Protected dug well
|
44 Participants
n=99 Participants • Household's water source.
|
47 Participants
n=101 Participants • Household's water source.
|
91 Participants
n=200 Participants • Household's water source.
|
|
Water source
Unprotected dug well
|
1 Participants
n=99 Participants • Household's water source.
|
1 Participants
n=101 Participants • Household's water source.
|
2 Participants
n=200 Participants • Household's water source.
|
|
Water source
Other
|
1 Participants
n=99 Participants • Household's water source.
|
0 Participants
n=101 Participants • Household's water source.
|
1 Participants
n=200 Participants • Household's water source.
|
|
Sanitary installation
Improved pit latrine
|
15 Participants
n=99 Participants • Household's sanitary installation.
|
13 Participants
n=101 Participants • Household's sanitary installation.
|
28 Participants
n=200 Participants • Household's sanitary installation.
|
|
Sanitary installation
Simple latrine with slab
|
78 Participants
n=99 Participants • Household's sanitary installation.
|
83 Participants
n=101 Participants • Household's sanitary installation.
|
161 Participants
n=200 Participants • Household's sanitary installation.
|
|
Sanitary installation
Simple sand dale latrine
|
6 Participants
n=99 Participants • Household's sanitary installation.
|
5 Participants
n=101 Participants • Household's sanitary installation.
|
11 Participants
n=200 Participants • Household's sanitary installation.
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Relapses were measured in children. Not the caregivers.
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)
Outcome measures
| Measure |
Mother Screening
n=93 Participants
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.
Mother education on how to perform MUAC assessment: Mothers will be trained to perform MUAC weekly on their children
|
Standard of Care
n=90 Participants
In this arm, mothers / children dyads will be enrolled. No study intervention will be performed. all other standard of care will be provided.
|
|---|---|---|
|
Time to Detection of Relapse
|
49 days
Interval 32.0 to 147.2
|
103 days
Interval 34.0 to 173.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This outcome was assessed among child participants only. Caregivers were not included in this outcome analysis.
Weight-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.
Outcome measures
| Measure |
Mother Screening
n=93 Participants
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.
Mother education on how to perform MUAC assessment: Mothers will be trained to perform MUAC weekly on their children
|
Standard of Care
n=90 Participants
In this arm, mothers / children dyads will be enrolled. No study intervention will be performed. all other standard of care will be provided.
|
|---|---|---|
|
Weight for Height Z Score (WHZ)
|
-0.52 z-score
Standard Deviation 1.3
|
-0.74 z-score
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This outcome was assessed among child participants only. Caregivers were not included in this outcome analysis.
Weight-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.
Outcome measures
| Measure |
Mother Screening
n=93 Participants
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.
Mother education on how to perform MUAC assessment: Mothers will be trained to perform MUAC weekly on their children
|
Standard of Care
n=90 Participants
In this arm, mothers / children dyads will be enrolled. No study intervention will be performed. all other standard of care will be provided.
|
|---|---|---|
|
Weight-for-age Z-score (WAZ)
|
-1.48 z-score
Standard Deviation 1.1
|
-1.71 z-score
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This outcome was assessed among child participants only. Caregivers were not included in this outcome analysis.
Height-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.
Outcome measures
| Measure |
Mother Screening
n=93 Participants
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.
Mother education on how to perform MUAC assessment: Mothers will be trained to perform MUAC weekly on their children
|
Standard of Care
n=90 Participants
In this arm, mothers / children dyads will be enrolled. No study intervention will be performed. all other standard of care will be provided.
|
|---|---|---|
|
Height-for-age Z-score (HAZ)
|
-2.17 z-score
Standard Deviation 1.5
|
-2.28 z-score
Standard Deviation 1.4
|
Adverse Events
Mother Screening
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 9 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Mother Screening
n=99 participants at risk
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.
Mother education on how to perform MUAC assessment: Mothers will be trained to perform MUAC weekly on their children
|
Standard of Care
n=101 participants at risk
In this arm, mothers / children dyads will be enrolled. No study intervention will be performed. all other standard of care will be provided.
|
|---|---|---|
|
General disorders
Hospitalization
|
3.0%
3/99 • 6 months
Adverse events were monitored and reported for the children only. Not the caregivers.
|
8.9%
9/101 • 6 months
Adverse events were monitored and reported for the children only. Not the caregivers.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place