Clinical trial NCT06627569: Exercise Effects on the Neurobiology Underlying Stress-related Eating Behaviors in Veterans
Official title: Exercise Effects on the Neurobiology Underlying Stress-Related Eating Behaviors in Veterans
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Overweight/Obesity
Stress
Keywords: Overweight
Obesity
Stress
Eating
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-10-04
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent change in blood oxygen level dependent (BOLD) response to visual food cues as measured by functional magnetic resonance imaging (fMRI)
timeFrame: Baseline, 12 weeks
measure: Change in serum cortisol response to counting task
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in heart rate response to counting task
timeFrame: Baseline, 12 weeks
Other outcomes:
measure: Change in percent body fat
timeFrame: Baseline, 12 weeks
measure: Percent change in body weight
timeFrame: Baseline, 12 weeks
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Kristina T. Legget, PhD
role: PRINCIPAL_INVESTIGATOR
References: