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Assessing the effect of the simplified and an optimized Integrated Management of Acute Malnutrition protocol for 6 to 59 months old children a 3 arm Non- Randomized controlled and parallel effectiveness trial of combined simplified approach models

Assessing the effect of the simplified and an optimized Integrated Management of Acute Malnutrition protocol for 6 to 59 months old children a 3 arm Non- Randomized controlled and parallel effectiveness trial of combined simplified approach models

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241217004
Enrollment
1420
Registered
2024-12-17
Start date
2025-01-27
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No health problems Assessing effectiveness of Combined Simplified approach Models

Interventions

MUAC less than 130 mm or bilateral pitting edema will be getting 1000kcal RUTF (Ready to Use Therapeutic Food) per day until discharge ,MUAC less than 130mm or bilateral pitting edema or WAZ less -3
experimental arm 1,Experimental arm 2,control arm 3

Sponsors

UNICEF
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 59 Months

Inclusion criteria

Inclusion criteria: Specific eligibility criteria for the Cohort-ET: - Age between 6 and 59 months - MUAC less than125 mm or bilateral pitting edema for control arm, MUAC<130 mm or bilateral pitting edema for experimental arm 1 and MUAC<130 mm or WAZ<-3 or bilateral pitting edema for experimental arm 2. - Referral from inpatient after management of complications - Consent to participate granted Specific eligibility criteria for the Cohort-NT: - Age between 6 and 59 months - WHZ<-3 or WAZ less than -3 and MUAC equal to or greater than 125 mm for the control arm, and MUAC equal to or greater than 125 mm for the experimental arm 1, and WHZ less than -3 MUAC equal to or greater than 130 mm for experimental arm 2. - No bilateral pitting edema - No sign of dehydration if history of diarrhea - Consent to participate granted

Exclusion criteria

Exclusion criteria: For Cohort ET - Presence of medical conditions requiring referral for hospitalization - Presence of 3 plus bilateral pitting edema grade or marasmus-kwashiorkor. They will be enrolled after graduating from inpatient management. - Fail appetite test (Refer to inpatient care) - Already enrolled in malnutrition program or was discharged from IMAM program within the past 6 months - sibling already enrolled (to avoid selection bias and ensure representativeness)) - Chronic disease/disability - Planning to move from the area permanently or for more than two weeks

Design outcomes

Primary

MeasureTime frame
Recovered 12 months percentage greater than 75%

Secondary

MeasureTime frame
recovered 12 months percentage greater than 75% this is a sphere standard , https://www/indikit.recovery-cure-rate

Countries

Timor-Leste

Contacts

Public ContactJoao Martins

UNICEF

joaosmartins@hotmail.com6777327467

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026