Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation

NCT05880108 | Recruiting DMC

• 2 other identifiers: F4572-R1I01RX004572-01A1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-COVID Conditions; Obesity

Keywords

COVID-19; Obesity; Senescence; Weight Loss; Exercise

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory Fitness (VO2max)

  VO2max (ml/kg/min) comparison between lean PCC naïve, lean with PCC, obese PCC naïve, and obese with PCC

  Baseline

Secondary Outcomes (2)

• Change in Cardiorespiratory Fitness (VO2max)

  Baseline, After 12 weeks of Weight Loss

• Change in adipose tissue cellular senescence

  Baseline, After 12 weeks of Weight Loss

Study Arms (2)

Weight Loss

EXPERIMENTAL

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.

Behavioral: 12-weeks of Weight Loss

Weight Stability

ACTIVE COMPARATOR

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.

Behavioral: 12-weeks of Weight Stability

Interventions

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.

Weight Loss

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.

Weight Stability

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Baltimore VA Medical Center: collaborator
• South Texas Veterans Health Care System: collaborator

Study Sites (2)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

RECRUITING

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229-4404, United States

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Obesity; COVID-19; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Body Weight Changes; Behavior

Study Officials

• Alice S. Ryan, PhD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Marcus, MS

CONTACT

(410) 605-7000; kristina.marcus@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to treatment allocation/group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Weight Loss Program (Diet and Exercise)

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: May 30, 2023
• Study Start: June 3, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)