Health TrialsbyHealthPanel

Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation

ConditionsPost-COVID ConditionsObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 80
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Weight LossExperimental treatment 1 intervention
Group B: Weight StabilityActive comparator 1 intervention

Trial outcomes

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

Time frame
Baseline

Secondary outcomes

1

Change in Cardiorespiratory Fitness (VO2max)

Change in VO2max (L/min)

Time frame
Baseline, After 12 weeks of Weight Loss
2

Change in adipose tissue cellular senescence

Change in adipose tissue chemokine (C-C motif) ligand 3 (CCL3)

Time frame
Baseline, After 12 weeks of Weight Loss

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Baltimore VA Medical Center

Collaborator

South Texas Veterans Health Care System

Collaborator

Source ClinicalTrials.gov
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