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
- Obesity
- Post-COVID Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - 80 Years
- Healthy Volunteers
- Accepted
Interventions
- 12-weeks of Weight Loss — BEHAVIORALParticipants 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 — BEHAVIORALParticipants 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 LossParticipants 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 StabilityParticipants 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
- Kristina Marcus, MS(410) 605-7000
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | Alice S. Ryan, PhD (PRINCIPAL_INVESTIGATOR) |
| South Texas Health Care System, San Antonio, TX | San Antonio | Texas | 78229-4404 |
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