Recruiting

Behavioral StrategiesModifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation

Sponsor:

VA Office of Research and Development

Code:

NCT05880108

Conditions

Post-COVID Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Interventions

12-weeks of Weight Loss

12-weeks of Weight Stability

Study Details

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.

Conditions

Post-COVID Conditions

Obesity

Study ID

NCT05880108

Start date

Jun 3, 2024

Status verified date

May, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

12-weeks of Weight Loss

12-weeks of Weight Stability

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.

Primary outcome measure

Cardiorespiratory Fitness (VO2max) [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Kristina Marcus, MS

(410) 605-7000 kristina.marcus@va.gov

Locations

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Kristina Marcus, MS

410-605-7000 kristina.marcus@va.gov

Principal Investigator:

Alice S. Ryan, PhD

South Texas Health Care System, San Antonio, TX

Recruiting

San Antonio, Texas, United States, 78229-4404

Contacts

Tiffany Cortes, MD

814-332-9939 tiffany.cortes@va.gov

Tim Calderon, MS

2106175300 tim.calderon@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

COVID-19
Obesity
Senescence
Weight Loss
Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-06-01.