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Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation

Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05880108
Acronym
MARVEL
Enrollment
150
Registered
2023-05-30
Start date
2024-06-03
Completion date
2029-09-30
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Post-COVID Conditions

Keywords

COVID-19, Obesity, Senescence, Weight Loss, Exercise

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.

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.

Interventions

BEHAVIORAL12-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.

BEHAVIORAL12-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.

Sponsors

VA Office of Research and Development
Lead SponsorFED
Baltimore VA Medical Center
CollaboratorFED
South Texas Veterans Health Care System
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessors will be blinded to treatment allocation/group assignment

Intervention model description

Weight Loss Program (Diet and Exercise)

Eligibility

Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiorespiratory Fitness (VO2max)BaselineVO2max (ml/kg/min) comparison between lean PCC naïve, lean with PCC, obese PCC naïve, and obese with PCC

Secondary

MeasureTime frameDescription
Change in Cardiorespiratory Fitness (VO2max)Baseline, After 12 weeks of Weight LossChange in VO2max (L/min)
Change in adipose tissue cellular senescenceBaseline, After 12 weeks of Weight LossChange in adipose tissue chemokine (C-C motif) ligand 3 (CCL3)

Countries

United States

Contacts

CONTACTKristina Marcus, MS
kristina.marcus@va.gov(410) 605-7000
PRINCIPAL_INVESTIGATORAlice S. Ryan, PhD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026