Family Mid-Upper Arm Circumference (MUAC) Follow-up After Recovery From Acute Malnutrition (MODAM-fMUAC)

Severe Acute Malnutrition Clinical Trial

— MODAM-fMUAC  

Official title:

Efficacy and Safety of Family Mid-upper Arm Circumference (MUAC) After Recovery From Severe and Moderate Acute Malnutrition

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06038071
• Other study ID #: MODAM-fMUAC
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: September 25, 2026

Study information

• Verified date: September 2023
• Source: Action Against Hunger USA
• Contact: Indi Trehan
• Phone: +12067696068
• Email: itrehan[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3600
• Est. completion date: September 25, 2026
• Est. primary completion date: September 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• children 6-59 months of old who recovered from SAM or MAM following treatment in either the MODAM-SAM or MODAM-MAM trials

Exclusion Criteria:

• caregiver not planning on remaining in the local area for the subsequent 6 months

Related Conditions & MeSH terms

• Malnutrition
• Moderate Acute Malnutrition
• Severe Acute Malnutrition

Intervention

Other:
• nutrition, IYCF, WASH education
nutrition, IYCF, WASH education
• scheduled anthropometric screening
anthropometric screening by health care workers at 1, 3, and 6 months
• family MUAC
family MUAC training for the primary caregiver present at the time of recovery

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Action Against Hunger USA	Ethiopian Public Health Institute, University of Washington

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of episodes of relapse to acute malnutrition identified		6 months
Secondary	weight-for-height Z-score (WHZ) at time relapse to acute malnutrition identified		6 months
Secondary	mid-upper arm circumference (MUAC) at time relapse to acute malnutrition identified		6 months
Secondary	number of episodes of relapse to edematous malnutrition / kwashiorkor identified		6 months
Secondary	recovery rates following treatment of relapse to acute malnutrition		6 months
Secondary	mortality		6 months
Secondary	hospitalization		6 months
Secondary	loss to follow-up		6 months