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RecruitingNCT05880108

Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation

◆ AI Clinical Summary

This study looks at how extra weight affects older Veterans recovering from COVID-19, including impacts on physical function and quality of life. Researchers will test whether a weight loss program can help improve recovery and reduce inflammation in the body.

Key Objective:The trial is testing whether weight loss through behavioral strategies can improve physical function and quality of life in older Veterans with Post-COVID Conditions.

Who to Consider:Older Veterans who are overweight or obese and experiencing lingering symptoms from COVID-19 should consider enrolling.

Trial Parameters

ConditionPost-COVID Conditions
SponsorVA Office of Research and Development
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment150
SexALL
Min AgeN/A
Max Age80 Years
Start Date2024-06-03
Completion2028-09-30
Interventions
12-weeks of Weight Loss12-weeks of Weight Stability

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Brief Summary

The research in this VA Merit will examine the effects of obesity and Post-COVID Conditions (PCC) on physical functioning, health-related quality of life, and adipose tissue inflammatory and cellular senescence profiles in older Veterans. Further, it will evaluate whether a weight loss intervention, including dietary modification and exercise, in obese Veterans with and without PCC will reduce systemic and adipose tissue inflammation and senescence and promote PCC recovery.

Eligibility Criteria

Inclusion Criteria: 1. U.S. Veteran 2. Self-reported COVID-19 naïve or COVID-19 \> 90 days ago for lean and obese PCC naïve or documented COVID-19 for the lean and obese PCC groups (At least one PCC symptom \>4 weeks) 3. Body Mass Index: 19-25 or 30-50 kg/m2 Exclusion Criteria: 1. Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments 2. Active inflammatory, COVID-19, autoimmune, infectious, hepatic (LFTs \> 2.5 x WNL), renal (eGFR\<45), gastrointestinal, malignant, and psychiatric disease 3. Uncontrolled diabetes (HbA1c \>10% or the current use of insulin) 4. Weight change within the past month of \>5 kg 5. Self-reported alcohol or drug abuse 6. Anti-coagulant medication usage

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