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

VA Office of Research and Development

Status: Begins enrollment this month

Conditions: Overweight/Obesity; Stress

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06627569

I01CX002752 (Other Grant/Funding Number)

ENDA-009-24S

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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
• Current eating disorder
• Current treatment with appetite-altering medications (e.g., GLP-1 agonists)
• Contraindication to MRI (weight > 500 lbs; claustrophobia; metal or electronic devices in the body)
• Cardiovascular disease, chronic kidney disease, pulmonary disease, or diabetes
• Unable to exercise due to cardiac, pulmonary, neurologic, or orthopedic reasons

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups

Exercise

Experimental group

Description:

Participants will complete 4 aerobic exercise training sessions per week for 12 weeks. The exercise program will begin at 15 minutes per session and duration will be gradually increased by 5 minutes each week until participants reach 30 minutes per session (with 5 min warm-up and cool-down). Exercise will be performed at a "moderate" intensity, which will be about 60-70% of your predicted maximal level. Participants will meet with study personnel once per week.

Treatment:

Behavioral: Exercise

Usual activity

No Intervention group

Description:

Participants will keep doing what they usually do for the 12-week intervention period. They will be asked not to change their usual physical activity levels during this period. They will meet with study personnel once per week