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Diet and Exercise for Post-COVID Syndrome (MARVEL Trial)
N/A
Waitlist Available
Led By Monica C Serra, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Postmenopausal status for women
No Post-COVID symptoms or at least one Post-COVID symptom lasting >4 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
MARVEL Trial Summary
This trial will explore how obesity and COVID-19 affect aging Veterans, and whether diet and exercise can reduce inflammation and help recovery.
Who is the study for?
This trial is for older U.S. Veterans who are either overweight or obese, with a BMI of 19-25 or 30-40 kg/m2. It's suitable for those with no Post-COVID symptoms or at least one symptom lasting more than four weeks. Women must be postmenopausal. Participants should not have conditions affecting study assessments, significant weight change recently, use anticoagulants, uncontrolled diabetes, active diseases including inflammatory and autoimmune, nor substance abuse issues.Check my eligibility
What is being tested?
The study tests if a weight loss program involving diet changes and exercise can reduce inflammation in fat tissue and improve recovery from Post-COVID Conditions (PCC) in obese Veterans. The intervention lasts for 12 weeks focused on losing weight followed by another 12 weeks aimed at maintaining the new weight.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with dietary changes and increased physical activity such as muscle soreness, fatigue, nutritional deficiencies if not monitored properly, and possible exacerbation of underlying health conditions.
MARVEL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman who has gone through menopause.
Select...
I either have no Post-COVID symptoms or have had symptoms for more than 4 weeks.
MARVEL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, after 12 weeks of weight loss
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, after 12 weeks of weight loss
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cardiorespiratory Fitness (VO2max)
Secondary outcome measures
Change in Cardiorespiratory Fitness (VO2max)
Change in adipose tissue cellular senescence
MARVEL Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Weight LossExperimental Treatment1 Intervention
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.
Group II: Weight StabilityActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Baltimore VA Medical CenterFED
32 Previous Clinical Trials
2,975 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,612 Previous Clinical Trials
3,305,593 Total Patients Enrolled
40 Trials studying Obesity
9,937 Patients Enrolled for Obesity
South Texas Veterans Health Care SystemFED
18 Previous Clinical Trials
5,943 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who has gone through menopause.I am taking blood thinner medications.I either have no Post-COVID symptoms or have had symptoms for more than 4 weeks.I do not have active inflammation, COVID-19, autoimmune, liver, kidney, stomach issues, cancer, or severe mental health problems.My diabetes is not under control, with HbA1c over 10% or I'm using insulin.I have a condition that makes it hard for me to do physical tests.You gained or lost more than 5 kilograms in the past month.You have a history of alcohol or drug abuse.Your body mass index (BMI) is between 19 and 25, or between 30 and 40.You have a history of developing keloids.
Research Study Groups:
This trial has the following groups:- Group 1: Weight Loss
- Group 2: Weight Stability
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the eligibility criteria for this investigation include individuals aged seventy-five or over?
"According to the trial's entrance requirements, eligible candidates must be between 55 and 80 years old."
Answered by AI
Are the criteria for enrollment in this trial compatible with my qualifications?
"To qualify for the trial, applicants must be within a certain age bracket (55-80) and have an obesity diagnosis. The study is currently looking to recruit 150 eligible candidates."
Answered by AI
Is this experiment in progress and are participants being accepted presently?
"The information found on clinicaltrials.gov indicates that this specific trial is not currently taking patients, as it was initially posted in January 2024 and last updated in May 2023. Nevertheless, there are an abundance of alternative trials actively seeking volunteers right now - 1,711 to be exact."
Answered by AI
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