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NCT Number: NCT05880108

Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • U.S. Veteran
  • 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)
  • Body Mass Index: 19-25 or 30-50 kg/m2

Exclusion criteria

  • Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments
  • Active inflammatory, COVID-19, autoimmune, infectious, hepatic (LFTs > 2.5 x WNL), renal (eGFR<45), gastrointestinal, malignant, and psychiatric disease
  • Uncontrolled diabetes (HbA1c >10% or the current use of insulin)
  • Weight change within the past month of >5 kg
  • Self-reported alcohol or drug abuse
  • Anti-coagulant medication usage

Treatment and study plan

12-weeks of Weight Loss

Behavioral

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.

12-weeks of Weight Stability

Behavioral

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 outcomes

  1. 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

Secondary outcomes

  1. Change in Cardiorespiratory Fitness (VO2max)

    Time frame: Baseline, After 12 weeks of Weight Loss

    Change in VO2max (L/min)

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Kristina Marcus, MS

CONTACT

[email protected]

(410) 605-7000

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Baltimore VA Medical Center
  • South Texas Veterans Health Care System

Registry information

Acronym: MARVEL

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
May 30, 2023
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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