Actively Recruiting

Phase Not Applicable
Age: 6Months - 59Months
All Genders
ID06038071

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

Led by Action Against Hunger USA · Updated on 2024-07-16

3600

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Action Against Hunger USA

Lead Sponsor

U

University of Washington

Collaborating Sponsor

AI-Summary

What this Trial Is About

Protocols for managing acute malnutrition in communities have not changed much in over 20 years, often involving complex treatments and supply challenges that limit care coverage. This research aims to test two new simplified community-based approaches to improve coverage for children recovering from severe and moderate acute malnutrition. The study focuses on evaluating a family-led mid-upper arm circumference (MUAC) screening method as a way for caregivers to monitor their child's health at home compared to usual health facility follow-up and standard care. The study assigns children who have recovered from malnutrition treatment into one of three groups: one receives nutrition, infant and young child feeding (IYCF), and water, sanitation, and hygiene (WASH) education with regular health worker screenings and a final 6-month visit; another group gets standard care with scheduled follow-up visits at 1, 3, and 6 months; and the last group receives standard care plus family MUAC training for the primary caregiver and a final 6-month visit. This randomized, double-blind trial compares these three approaches to see which best identifies relapse to malnutrition. Participants will be monitored for 6 months, during which researchers will track relapse episodes of acute malnutrition, nutritional status via weight-for-height and MUAC measurements, rates of recovery from relapse, mortality, hospitalizations, and loss to follow-up. Caregivers will be involved in monitoring through training or health worker visits, and the study aims to assess how well family MUAC screening works as a self-referral strategy versus scheduled clinical follow-up. The total study period for each child is 6 months after recovery from initial treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Months - 59Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 6 to 59 months who have recovered from severe or moderate acute malnutrition following treatment in the MODAM-SAM or MODAM-MAM trials
Not Eligible

You will not qualify if you...

  • Caregiver not planning to remain in the local area for the next 6 months

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - 6 months

Participants undergo assessments to monitor for relapse of acute malnutrition after recovery.

Scheduled visits at 1 month, 3 months, and 6 months after discharge

Trial Site Locations

Total: 3 locations

1

Sekota

Sekota, Amhara, Ethiopia

Not Yet Recruiting

2

Teltele

Teltelē, Oromiya, Ethiopia

Actively Recruiting

3

Gode

Gode, Somali, Ethiopia

Actively Recruiting

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Research Team

I

Indi Trehan

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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Published Research Related To This Trial

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.

Indi Trehan, Yosef Beyene, Hiwot Darsene...

https://pubmed.ncbi.nlm.nih.gov/40200326