Severe Acute MalnutritionNCT05932992
Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition
A study testing Mother education on how to perform MUAC assessment in people with Severe Acute Malnutrition, run by University of California, San Francisco at 1 site in Burkina Faso.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Severe Acute Malnutrition
- What is being tested?
- Mother education on how to perform MUAC assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 1 Dec 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Severe Acute Malnutrition
- Being tested
- Mother education on how to perform MUAC assessment
- Medical subject headings
- Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother education on how to perform MUAC assessmentOther
Mothers will be trained to perform MUAC weekly on their children
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (3)
Weight for Height Z Score (WHZ)
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.
Measured: 6 months
Weight-for-age Z-score (WAZ)
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.
Measured: 6 months
Height-for-age Z-score (HAZ)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Dec 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe Acute MalnutritionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial of mothers being trained to measure MUAC vs standard of care to prevent relapse
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Sante de Nouna, Burkina Faso
- Responsible party
- Sponsor
- Investigators
- Catherine Oldenburg, ScD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932992
- Sponsor's protocol ID
- 23-38829
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2023
- Last updated
- 17 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41569394Dah 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;12(1):22. doi: 10.1186/s40814-025-01752-z.
PubMed 41527000
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition
- ClinicalTrials.gov ID
- NCT05932992
- Acronym / sponsor ID
- 23-38829
- Conditions
- Severe Acute Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Centre de Recherche en Sante de Nouna, Burkina Faso
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Posted 17 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial of mothers being trained to measure MUAC vs standard of care to prevent relapse
| Arm | Type | Receives |
|---|---|---|
| Mother screening | Active comparator | Other: Mother education on how to perform MUAC assessmentIn 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. |
| 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. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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 ≥
- Family is planning to stay in the study area for 6 months
- Appropriate consent from the caregiver or guardian
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mother education on how to perform MUAC assessmentMothers will be trained to perform MUAC weekly on their children | Other | Mother screening |
Primary outcome
Time to Detection of Relapse
Time frame: 6 months
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)
3 secondary outcomes
Weight for Height Z Score (WHZ)
Time frame: 6 months
Weight-for-age Z-score (WAZ)
Time frame: 6 months
Height-for-age Z-score (HAZ)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41569394Bountogo 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.
- Derived from this study: PubMed 41527000Dah 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;12(1):22. doi: 10.1186/s40814-025-01752-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Oldenburg, ScD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mother education on how to perform MUAC assessment in people with Severe Acute Malnutrition, run by University of California, San Francisco at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Detection of Relapse (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05932992, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.