Weight loss and exercise program for older Veterans recovering from COVID-19
Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation
This study is testing if a 12-week weight loss and exercise program can help older Veterans who are recovering from COVID-19 feel better and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | N/A to 80 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT05880108 on ClinicalTrials.gov |
What this trial studies
This research examines how obesity and Post-COVID Conditions (PCC) affect physical functioning and health-related quality of life in older Veterans. It aims to evaluate the impact of a 12-week weight loss intervention, which includes dietary changes and exercise, on reducing inflammation and promoting recovery from PCC. The study will involve a randomized controlled trial comparing the effects of weight loss versus weight stability in Veterans with varying degrees of post-COVID symptoms. The goal is to better understand the relationship between obesity, inflammation, and recovery from PCC.
Who should consider this trial
Good fit: Ideal candidates are U.S. Veterans who are either experiencing post-COVID symptoms or have recovered but are overweight or obese.
Not a fit: Patients with significant comorbid conditions that limit physical activity or those with uncontrolled diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve recovery outcomes and quality of life for Veterans suffering from obesity and post-COVID conditions.
How similar studies have performed: While there is limited research specifically on this approach, studies have shown that weight loss and exercise can improve health outcomes in similar populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland and 1 other locations
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States (Recruiting)
- South Texas Health Care System, San Antonio, TX — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Alice S. Ryan, PhD — Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
- Study coordinator: Kristina Marcus, MS
- Email: kristina.marcus@va.gov
- Phone: (410) 605-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.