search
Back to results

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

Primary Purpose

Post-COVID Conditions, Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
12-weeks of Weight Loss
12-weeks of Weight Stability
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-COVID Conditions focused on measuring COVID-19, Obesity, Senescence, Weight Loss, Exercise

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
  • South Texas Health Care System, San Antonio, TX

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Weight Loss

Weight Stability

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cardiorespiratory Fitness (VO2max)
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)
Change in VO2max (L/min)
Change in adipose tissue cellular senescence
Change in adipose tissue chemokine (C-C motif) ligand 3 (CCL3)

Full Information

First Posted
May 25, 2023
Last Updated
May 25, 2023
Sponsor
VA Office of Research and Development
Collaborators
South Texas Veterans Health Care System, Baltimore VA Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05880108
Brief Title
Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation
Acronym
MARVEL
Official Title
Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
September 30, 2028 (Anticipated)
Study Completion Date
September 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
South Texas Veterans Health Care System, Baltimore VA Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-COVID Conditions, Obesity
Keywords
COVID-19, Obesity, Senescence, Weight Loss, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Weight Loss Program (Diet and Exercise)
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be blinded to treatment allocation/group assignment
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Weight Loss
Arm Type
Experimental
Arm Description
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.
Arm Title
Weight Stability
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
12-weeks of Weight Loss
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
12-weeks of Weight Stability
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiorespiratory Fitness (VO2max)
Description
VO2max (ml/kg/min) comparison between lean PCC naïve, lean with PCC, obese PCC naïve, and obese with PCC
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Change in Cardiorespiratory Fitness (VO2max)
Description
Change in VO2max (L/min)
Time Frame
Baseline, After 12 weeks of Weight Loss
Title
Change in adipose tissue cellular senescence
Description
Change in adipose tissue chemokine (C-C motif) ligand 3 (CCL3)
Time Frame
Baseline, After 12 weeks of Weight Loss

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica C Serra, PhD
Phone
(814) 332-9939
Email
Monica.Serra@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Tim Calderon, MS
Phone
(210) 617-5300
Ext
13898
Email
tim.calderon@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica C Serra, PhD
Organizational Affiliation
South Texas Health Care System, San Antonio, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Ryan, PhD
Phone
410-605-7851
Email
alice.ryan@va.gov
First Name & Middle Initial & Last Name & Degree
Kristina Marcus
Phone
4106057000
Email
kristina.marcus@va.gov
Facility Name
South Texas Health Care System, San Antonio, TX
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-4404
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica C Serra, PhD
Phone
814-332-9939
Email
Monica.Serra@va.gov
First Name & Middle Initial & Last Name & Degree
Tim Calderon, MS
Phone
(210) 617-5300
Ext
13898
Email
tim.calderon@va.gov
First Name & Middle Initial & Last Name & Degree
Monica C Serra, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation

We'll reach out to this number within 24 hrs