Malnutrition, ChildMAMANNCT06599580
Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition (Full Scale Trial)
A study testing Training caregivers to screen children for malnutrition relapse and Reduced follow-up schedule in people with Malnutrition, Child and Malnutrition, Infant, run by University of California, San Francisco at 1 site in Burkina Faso.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 54 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Child, Malnutrition, Infant, Malnutrition or Risk of Malnutrition
- What is being tested?
- Training caregivers to screen children for malnutrition relapse and Reduced follow-up schedule
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 20 Mar 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 54 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 6-54 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hadley Burroughs contact
Burkina Faso1 site, 1 recruiting
- Recruiting
Centre de recherche en sante de nouna
Nouna
Ali Sie, MD, PHD, +226 70 20 47 78, sieali@yahoo.fr
Mamadou Bountogo, MD, PHD, +226 70 39 89 44, drbountogo@yahoo.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Malnutrition, Child, Malnutrition, Infant, Malnutrition or Risk of Malnutrition, Hemoglobin Level Measurement, Anemia
- Being tested
- Training caregivers to screen children for malnutrition relapse, Reduced follow-up schedule
- Keywords
- MUAC (mid-upper arm circumference), Caregiver screening, malnutrition, home based malnutrition screening
- Medical subject headings
- Child Nutrition Disorders, Infant Nutrition Disorders, Malnutrition, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training caregivers to screen children for malnutrition relapseBehavioural
Also called Caregiver and/or mother mid-upper arm circumference screening
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.
Reduced follow-up scheduleOther
Also called Reduced clinic visits
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Training caregivers to screen children for malnutrition relapse; Other: Reduced follow-up schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 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.
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 posted19 Sep 2024
- Study start20 Mar 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition, ChildStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,400 participants (estimated)
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, Thrasher Research Fund
- Responsible party
- Sponsor
- Investigators
- Catherine Oldenburg, ScD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599580
- Sponsor's protocol ID
- 24-42418
- Acronym
- MAMAN
- Status last verified
- Nov 2025
- First submitted
- 13 Sep 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. 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 (MAMAN)
- ClinicalTrials.gov ID
- NCT06599580
- Acronym / sponsor ID
- MAMAN / 24-42418
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Centre de Recherche en Sante de Nouna, Burkina Faso, Thrasher Research Fund
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Training caregivers to screen children for malnutrition relapseThis 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. |
| Caregiver mid-upper arm circumference (MUAC) screening and a reduced follow-up schedule | Experimental | Behavioral: Training caregivers to screen children for malnutrition relapse, Other: Reduced follow-up scheduleThis 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. |
Who may qualify
- Ages
- 6 to 54 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Training caregivers to screen children for malnutrition relapseAlso: Caregiver and/or mother mid-upper arm circumference screeningCaregivers 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. | Behavioural | 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 scheduleAlso: Reduced clinic visitsCaregivers 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 | Caregiver mid-upper arm circumference (MUAC) screening and a reduced follow-up schedule |
Primary outcome
Cumulative incidence of relapse
Time frame: 6 months
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.
2 secondary outcomes
Time to detection of relapse
Time frame: 6 months
Cumulative incidence of relapse to MAM or SAM separately
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Malnutrition, Child
RecruitingPhase 4
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Malnutrition, Child, Malnutrition
Recruiting
Development of a Digital Personalised Nutrition Tool for Adolescents Undergoing Cancer Treatment
Paediatric Oncology, Malnutrition in Children
Recruiting
Family-Based Nutrition Intervention to Prevent Overweight and Obesity in School-Age Children.
Overweight and/or Obesity, Children - Malnutrition
Recruiting
7-Day vs 1-Day Packaging for Small Quantity Lipid-Based Nutrient Supplements in Ghana (SQLNS:7D-1D Comparison)
Child Malnutrition
Recruiting
Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia
Acute Malnutrition, Severe, Malnutrition, Child
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.
Hadley Burroughs contact
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 Training caregivers to screen children for malnutrition relapse and Reduced follow-up schedule in people with Malnutrition, Child and Malnutrition, Infant, 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Oldenburg, ScD (415-502-8843, catherine.oldenburg@uscf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence 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?
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 20 Nov 2025; AzTrials last refreshed its copy on 27 Oct 2026.