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NCT Number: NCT06627569

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

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.

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Key information

Conditions

Overweight/Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location contact

Kristina T Legget, PhD

CONTACT

[email protected]

720-724-5809

Kristina T. Legget, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

12 weeks of aerobic exercise, with 4 sessions per week.

Primary outcomes

  1. Percent change in blood oxygen level dependent (BOLD) response to visual food cues as measured by functional magnetic resonance imaging (fMRI)

    Time frame: 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.

  2. Change in serum cortisol response to counting task

    Time frame: 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 outcomes

  1. Change in heart rate response to counting task

    Time frame: 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).

Other outcomes

  1. Change in percent body fat

    Time frame: Baseline, 12 weeks

    Change in percent body fat, as measured by dual-energy x-ray absorptiometry, from baseline to after the 12-week intervention period.

  2. Percent change in body weight

    Time frame: Baseline, 12 weeks

    Percent change in body weight (kg) from baseline to after the 12-week intervention period.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristina T Legget, PhD

CONTACT

[email protected]

(720) 724-5809

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Oct 4, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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