Exercise Effects on the Neurobiology Underlying Stress-related Eating Behaviors in Veterans

Not Applicable

Not yet recruiting

• Conditions: Overweight/Obesity; Stress

• Registration Number: NCT06627569
• Lead Sponsor: VA Office of Research and Development

Brief Summary

The purpose of this study is to learn more about how common lifestyle interventions, such as exercise, affect how our brains respond to performing thinking tasks and to viewing pictures of foods and various other objects. The investigators are also interested in how changes in hormones that might be different in men and women could affect how lifestyle interventions change these brain responses.

Detailed Description

The purpose of this study is to learn more about how common lifestyle interventions, such as exercise, affect how our brains respond to performing thinking tasks and to viewing pictures of foods and various other objects. The investigators are also interested in how changes in hormones that might be different in men and women could affect how lifestyle interventions change these brain responses. This will help us to better understand how different lifestyle interventions affect the brain and how this might relate to various behaviors. Eligible participants will be asked to complete 2 study days before and again after a 12-week intervention period, during which they will either continue with usual activities or be asked to complete exercise sessions four times per week. They will be randomly assigned to one of these conditions (exercise or not) and will not be able to choose their group assignment.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-03
• Last Update Submitted: 2024-10-03
• Study First Posted: 2024-10-04
• Last Update Posted: 2024-10-04
• Study Start: 2024-12-01
• Primary Completion: 2028-09-30
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Veterans 18-75 years old
• BMI of 25 or greater
• Physically inactive
• Able to attend study visits in person in Aurora, CO

Exclusion Criteria

• Currently pregnant
• History of bariatric surgery
• Contraindication to MRI (weight > 500 lbs; claustrophobia; metal or electronic devices in the body)
• Unable to exercise due to cardiac, pulmonary, neurologic, or orthopedic reasons
• Unable to pass screening graded exercise treadmill test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent change in blood oxygen level dependent (BOLD) response to visual food cues as measured by functional magnetic resonance imaging (fMRI)	Baseline, 12 weeks	Percent change in blood oxygen level dependent (BOLD) response from baseline to after the 12-week intervention period while viewing visual food cues. The primary contrast of interest is the comparison of high-calorie food images to nonfood object images.
Change in serum cortisol response to counting task	Baseline, 12 weeks	Change from baseline to after the 12-week intervention period in serum cortisol levels (mcg/dL) throughout a counting task involving mental math (measured as area under the curve).

Secondary Outcome Measures

Name	Time	Method
Change in heart rate response to counting task	Baseline, 12 weeks	Change from baseline to after the 12-week intervention period in heart rate (measured by photoplethysmograph; aggregated in 1 min intervals) throughout a counting task involving mental math (measured as area under the curve).

Trial Locations

Locations (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO; 🇺🇸 Aurora, Colorado, United States