Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
VA Office of Research and Development
Study ID
NCT05880108
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 80 Years
Healthy Volunteers
Accepted

Interventions

  • 12-weeks of Weight Loss — BEHAVIORAL
    Participants will be asked to participate in a 1x/week center-based or tele-health nutrition diet class, 2x/week center-based exercise classes, and 1x/week exercise session conducted on their own for \~12 weeks.
  • 12-weeks of Weight Stability — BEHAVIORAL
    Participants will be asked to participate in a 1x/week center-based or tele-health education class, 2x/week center-based stretching/balance classes, and 1x/week stretching/balance session conducted on their own for \~12 weeks.

Study Details

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.

Key Dates

Start date
Jun 3, 2024
Status verified
May 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Weight Loss
    Participants will be asked to participate in a 1x/week center-based or tele-health nutrition diet class, 2x/week center-based exercise classes, and 1x/week exercise session conducted on their own for approximately 12 weeks.
  • Active Comparator: Weight Stability
    Participants will be asked to participate in a 1x/week center-based or tele-health education class, 2x/week center-based or tele-health stretching/balance classes, and 1x/week stretching/balance session conducted on their own for approximately 12 weeks.

Primary Outcome Measure

Cardiorespiratory Fitness (VO2max) [ Time Frame: Baseline ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDBaltimoreMaryland21201
Kristina Marcus, MS
410-605-7000
Alice S. Ryan, PhD (PRINCIPAL_INVESTIGATOR)
South Texas Health Care System, San Antonio, TXSan AntonioTexas78229-4404
Tiffany Cortes, MD
814-332-9939
Tim Calderon, MS
2106175300

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