Severe Acute MalnutritionMODAM-fMUACNCT06038071
Family Mid-Upper Arm Circumference (MUAC) Follow-up After Recovery From Acute Malnutrition (MODAM-fMUAC)
A study testing nutrition, IYCF, WASH education, scheduled anthropometric screening and family MUAC in people with Severe Acute Malnutrition and Moderate Acute Malnutrition, run by Action Against Hunger USA at 3 sites in Ethiopia.
Trial summary
Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care… Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Severe Acute Malnutrition, Moderate Acute Malnutrition
- What is being tested?
- nutrition, IYCF, WASH education, scheduled anthropometric screening and family MUAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,600 participants
- Where
- 3 sitesEthiopia
- Study dates
- 25 Sep 2023to 25 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child
Who may be able to join
- children 6-59 months of old who recovered from SAM or MAM following treatment in either the MODAM-SAM or MODAM-MAM trials
Who cannot join
- caregiver not planning on remaining in the local area for the subsequent 6 months
Trial locations and contacts
3 sites in 1 country.
Ethiopia3 sites, 3 recruiting
- Recruiting
Gode
Gode, Somali
Indi Trehan
- Not yet recruiting
Sekota
Sekota, Amhara
Indi Trehan
- Recruiting
Teltele
Teltelē, Oromiya
Indi Trehan
About this study
Official title: Efficacy and Safety of Family Mid-upper Arm Circumference (MUAC) After Recovery From Severe and Moderate Acute Malnutrition
Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. The overarching goal of this research project is to simultaneously test two novel simplified approaches in CMAM with potential to improve program coverage. The simplified approach includes two parallel clinical trials for SAM and MAM treatment. For the Family MUAC follow-up study, children who recover from these two parallel clinical trials will be enrolled in trial to test the effectiveness of MUAC screening at home by the child's caregivers as a self-referral strategy, compared to a scheduled health facility-led strategy and the standard of care of community-based follow-up visits.
- Being tested
- nutrition, IYCF, WASH education, scheduled anthropometric screening, family MUAC
- 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.
nutrition, IYCF, WASH educationOther
nutrition, IYCF, WASH education
scheduled anthropometric screeningOther
anthropometric screening by health care workers at 1, 3, and 6 months
family MUACOther
family MUAC training for the primary caregiver present at the time of recovery
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | nutrition, IYCF, and WASH education at discharge, followed by regular community-based screenings led by health extension workers, with one final visit scheduled at 6 months after discharge Receives: Other: nutrition, IYCF, WASH education |
| scheduled followup | Active comparator | standard of care plus scheduled follow-up visits at 1 month, 3 months, 6 months after discharge Receives: Other: nutrition, IYCF, WASH education; Other: scheduled anthropometric screening |
| family MUAC | Experimental | standard of care plus Family MUAC training for the primary caregiver present at the time of recovery, with one final visit scheduled at 6 months after discharge Receives: Other: nutrition, IYCF, WASH education; Other: family MUAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of episodes of relapse to acute malnutrition identified
Measured: 6 months
Secondary outcomes (7)
weight-for-height Z-score (WHZ) at time relapse to acute malnutrition identified
Measured: 6 months
mid-upper arm circumference (MUAC) at time relapse to acute malnutrition identified
Measured: 6 months
number of episodes of relapse to edematous malnutrition / kwashiorkor identified
Measured: 6 months
recovery rates following treatment of relapse to acute malnutrition
Measured: 6 months
mortality
Measured: 6 months
hospitalization
Measured: 6 months
loss to follow-up
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 posted14 Sep 2023
- Study start25 Sep 2023
- Primary completion25 Sep 2026 (estimated)
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Acute MalnutritionStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Action Against Hunger USA
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Ethiopian Public Health Institute
- Responsible party
- Principal investigator, Heather Stobaugh, Action Against Hunger USA
- Investigators
- Heather C Stobaugh, Principal investigator, Action Against Hunger USAIndi Trehan, MD MPH DTM&H, Principal investigator, University of WashingtonYosef B Asefaw, MSc, Principal investigator, Ethiopian Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038071
- Sponsor's protocol ID
- MODAM-fMUAC
- Acronym
- MODAM-fMUAC
- Status last verified
- Jul 2024
- First submitted
- 8 Sep 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Trehan I, Beyene Y, Darsene H, Adams BS, Wrabel M, Gizaw G, Legese LA, Cichon B, Chitekwe S, Shellemew MW, Tessema M, Stobaugh HC. The Modified Dosages for Acute Malnutrition (MODAM) study: protocol for three integrated randomized controlled trials of novel approaches for the management of childhood wasting in Ethiopia. BMC Nutr. 2025 Apr 8;11(1):71. doi: 10.1186/s40795-025-01054-w.
PubMed 40200326
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Family Mid-upper Arm Circumference (MUAC) After Recovery From Severe and Moderate Acute Malnutrition
- ClinicalTrials.gov ID
- NCT06038071
- Acronym / sponsor ID
- MODAM-fMUAC / MODAM-fMUAC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Action Against Hunger USAUniversity, hospital or other
- Collaborators
- University of Washington, Ethiopian Public Health Institute
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 14 Sep 2023 (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.
Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. The overarching goal of this research project is to simultaneously test two novel simplified approaches in CMAM with potential to improve program coverage. The simplified approach includes two parallel clinical trials for SAM and MAM treatment. For the Family MUAC follow-up study, children who recover from these two parallel clinical trials will be enrolled in trial to test the effectiveness of MUAC screening at home by the child's caregivers as a self-referral strategy, compared to a scheduled health facility-led strategy and the standard of care of community-based follow-up visits.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: nutrition, IYCF, WASH educationnutrition, IYCF, and WASH education at discharge, followed by regular community-based screenings led by health extension workers, with one final visit scheduled at 6 months after discharge |
| scheduled followup | Active comparator | Other: nutrition, IYCF, WASH education, Other: scheduled anthropometric screeningstandard of care plus scheduled follow-up visits at 1 month, 3 months, 6 months after discharge |
| family MUAC | Experimental | Other: nutrition, IYCF, WASH education, Other: family MUACstandard of care plus Family MUAC training for the primary caregiver present at the time of recovery, with one final visit scheduled at 6 months after discharge |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children 6-59 months of old who recovered from SAM or MAM following treatment in either the MODAM-SAM or MODAM-MAM trials
Key exclusion criteria (1 listed)
- caregiver not planning on remaining in the local area for the subsequent 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 |
|---|---|---|
| nutrition, IYCF, WASH educationnutrition, IYCF, WASH education | Other | Control Group, family MUAC, scheduled followup |
| scheduled anthropometric screeninganthropometric screening by health care workers at 1, 3, and 6 months | Other | scheduled followup |
| family MUACfamily MUAC training for the primary caregiver present at the time of recovery | Other | family MUAC |
Primary outcome
number of episodes of relapse to acute malnutrition identified
Time frame: 6 months
7 secondary outcomes
weight-for-height Z-score (WHZ) at time relapse to acute malnutrition identified
Time frame: 6 months
mid-upper arm circumference (MUAC) at time relapse to acute malnutrition identified
Time frame: 6 months
number of episodes of relapse to edematous malnutrition / kwashiorkor identified
Time frame: 6 months
recovery rates following treatment of relapse to acute malnutrition
Time frame: 6 months
mortality
Time frame: 6 months
hospitalization
Time frame: 6 months
loss to follow-up
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Derived from this study: PubMed 40200326Trehan I, Beyene Y, Darsene H, Adams BS, Wrabel M, Gizaw G, Legese LA, Cichon B, Chitekwe S, Shellemew MW, Tessema M, Stobaugh HC. The Modified Dosages for Acute Malnutrition (MODAM) study: protocol for three integrated randomized controlled trials of novel approaches for the management of childhood wasting in Ethiopia. BMC Nutr. 2025 Apr 8;11(1):71. doi: 10.1186/s40795-025-01054-w.
- Individual participant dataSharing planned: Yes
Related trials for Severe Acute Malnutrition
Active, not recruiting
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The Relapse to Acute Malnutrition Prevention (RAMP) Trial
Acute Malnutrition in Childhood, Acute Malnutrition, Severe
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Opportunistic Pneumococcal Immunisation Trial in MALnutrition
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Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia
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Choline to Improve Malnutrition and Enhance Cognition
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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.
Heather C Stobaugh principal investigator
Action Against Hunger USA
Indi Trehan, MD MPH DTM&H principal investigator
University of Washington
Yosef B Asefaw, MSc principal investigator
Ethiopian Public Health Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutrition, IYCF, WASH education, scheduled anthropometric screening and family MUAC in people with Severe Acute Malnutrition and Moderate Acute Malnutrition, run by Action Against Hunger USA at 3 sites in Ethiopia.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ethiopia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Indi Trehan (+12067696068, itrehan@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of episodes of relapse to acute malnutrition identified (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 NCT06038071, which also lists 1 linked publication.
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 16 Jul 2024.