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

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Not yet recruiting

CT.gov ID

NCT05880108

Collaborator

South Texas Veterans Health Care System (U.S. Fed), Baltimore Veterans Affairs Medical Center (Other)

150

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-COVID Conditions Obesity	Behavioral: 12-weeks of Weight Loss Behavioral: 12-weeks of Weight Stability	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Weight Loss Program (Diet and Exercise)Weight Loss Program (Diet and Exercise)

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcome assessors will be blinded to treatment allocation/group assignment

Primary Purpose:

Treatment

Official Title:

Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Sep 30, 2028

Anticipated Study Completion Date :

Sep 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Weight Loss Participants will be asked to participate in a 1x/week center-based nutrition diet class, 2x/week center-based exercise classes, and 1x/week exercise session conducted on their own for 12 weeks.	Behavioral: 12-weeks of Weight Loss Participants will be asked to participate in a 1x/week center-based 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 health education class, 2x/week center-based stretching/balance classes, and 1x/week stretching/balance session conducted on their own for 12 weeks.	Behavioral: 12-weeks of Weight Stability Participants will be asked to participate in a 1x/week center-based health education class, 2x/week center-based stretching/balance classes, and 1x/week stretching/balance session conducted on their own for 12 weeks.

Arm

Intervention/Treatment

Experimental: Weight Loss

Participants will be asked to participate in a 1x/week center-based nutrition diet class, 2x/week center-based exercise classes, and 1x/week exercise session conducted on their own for 12 weeks.

Behavioral: 12-weeks of Weight Loss

Participants will be asked to participate in a 1x/week center-based 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 health education class, 2x/week center-based stretching/balance classes, and 1x/week stretching/balance session conducted on their own for 12 weeks.

Behavioral: 12-weeks of Weight Stability

Outcome Measures

Primary Outcome Measures

Cardiorespiratory Fitness (VO2max) [Baseline]
VO2max (ml/kg/min) comparison between lean PCC naïve, lean with PCC, obese PCC naïve, and obese with PCC

Secondary Outcome Measures

Change in Cardiorespiratory Fitness (VO2max) [Baseline, After 12 weeks of Weight Loss]
Change in VO2max (L/min)
Change in adipose tissue cellular senescence [Baseline, After 12 weeks of Weight Loss]
Change in adipose tissue chemokine (C-C motif) ligand 3 (CCL3)

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

U.S. Veteran
No Post-COVID symptoms or at least one Post-COVID symptom lasting >4 weeks
Body Mass Index: 19-25 or 30-40 kg/m2
Postmenopausal status for women

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
History of keloid formation
Self-reported alcohol or drug abuse
Anti-coagulant medication usage

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland	United States	21201
2	South Texas Health Care System, San Antonio, TX	San Antonio	Texas	United States	78229-4404