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

VA Office of Research and Development

Status: Enrolling

Conditions: Post-COVID Conditions; Obesity

Treatments: Behavioral: 12-weeks of Weight Stability; Behavioral: 12-weeks of Weight Loss

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05880108

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

F4572-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Weight Loss

Experimental group

Description:

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.

Treatment:

Behavioral: 12-weeks of Weight Loss

Weight Stability

Active Comparator group

Description:

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.

Treatment:

Behavioral: 12-weeks of Weight Stability