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Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation
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.
Conditions:
🦠 Post-COVID Conditions 🦠 Obesity
🗓️ Study Start (Actual) 3 June 2024
🗓️ Primary Completion (Estimated) 30 September 2028
✅ Study Completion (Estimated) 30 September 2028
👥 Enrollment (Estimated) 150
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Baltimore, Maryland, United States
📍 San Antonio, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. U.S. Veteran
    • 2. No Post-COVID symptoms or at least one Post-COVID symptom lasting \>4 weeks
    • 3. Body Mass Index: 19-25 or 30-40 kg/m2
    • 4. Postmenopausal status for women

    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. History of keloid formation
    • 6. Self-reported alcohol or drug abuse
    • 7. Anti-coagulant medication usage
Ages Eligible for Study: 55 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 May 2023
  • First Submitted that Met QC Criteria 25 May 2023
  • First Posted 30 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 June 2024
  • Last Update Posted 7 June 2024
  • Last Verified June 2024
I'm interested ...!!