Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation (MARVEL)

May 27, 2026 updated by: VA Office of Research and Development
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Findings of post-acute sequelae of Post-COVID Conditions (PCC) manifestations of fatigue, pain, dyspnea, and muscle weakness, provide a strong rationale for rehabilitation; yet few formal studies exist and the effects of severe acute respiratory syndrome coronavirus-2 infection on function are not well described. Notably, two-thirds of Veterans are overweight and obese, rendering excess adiposity a significant risk factor and a high-priority area related to PCC prevention and care. Obesity increases the risk of severe illness in Veterans recovering from PCC, but how it does so is not fully understood.

Recent research suggests that excess adipose tissue is associated with adverse changes in adipose cellular function, and that these variations may be involved in the biology of aging and the etiology of aging-related diseases. Adipose tissue contains cells that have undergone cellular senescence, which induces inflammation, cytotoxicity, and metabolic dysfunction in other cells and tissues. However, the precise role of adipose tissue cellular composition on PCC recovery is limited.

Thus, the investigators propose to evaluate the role of obesity and PCC on physical functioning, health-related quality of life (HRQOL), and systemic and adipose tissue inflammatory and cellular senescence profiles in ethnically diverse older Veterans from the Audie Murphy (San Antonio) and Baltimore VA Medical Centers. Further, the investigators propose a randomized controlled trial to determine whether a reduction in body weight and increased physical function by a weight loss intervention (WL), including dietary modification and exercise, in obese Veterans with PCC will reduce systemic and adipose tissue inflammation and senescence, which will have important implications for PCC recovery.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
        • Principal Investigator:
          • Alice S. Ryan, PhD
        • Contact:
    • Texas
      • San Antonio, Texas, United States, 78229-4404
        • Recruiting
        • South Texas Health Care System, San Antonio, TX
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 12-weeks of 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 ~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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiorespiratory Fitness (VO2max)
Time Frame: Baseline
VO2max (ml/kg/min) comparison between lean PCC naïve, lean with PCC, obese PCC naïve, and obese with PCC
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cardiorespiratory Fitness (VO2max)
Time Frame: Baseline, After 12 weeks of Weight Loss
Change in VO2max (L/min)
Baseline, After 12 weeks of Weight Loss
Change in adipose tissue cellular senescence
Time Frame: Baseline, After 12 weeks of Weight Loss
Change in adipose tissue chemokine (C-C motif) ligand 3 (CCL3)
Baseline, After 12 weeks of Weight Loss

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

Baltimore VA Medical Center
South Texas Veterans Health Care System

Investigators

  • Principal Investigator: Alice S. Ryan, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

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 Major Dates

Study Start (Actual)

June 3, 2024

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

September 30, 2029

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F4572-R
  • 1I01RX004572-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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