Recruiting

Lifestyle Interventions

Sponsor:

VA Office of Research and Development

Code:

NCT06627569

Conditions

Overweight/Obesity

Stress

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Exercise

Study Details

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.

Conditions

Overweight/Obesity

Stress

Study ID

NCT06627569

Start date

Sep 15, 2026

Status verified date

Sep, 2026

Completion date

Aug 30, 2030

Anticipated

Primary completion date

Aug 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Veteran
  • Body mass index (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., glucagon-like peptide-1 (GLP-1) agonists)
  • Contraindication to MRI (weight > 500 pounds (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

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Exercise

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.

no intervention: Usual activity

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

Interventions

Exercise

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

Primary outcome measure

  • 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 ]
  • Change in serum cortisol response to counting task [ Time Frame: Baseline, 12 weeks ]

Central Contacts and Locations

Central contacts

Kristina T Legget, PhD

(720) 724-5809kristina.legget@va.gov

Locations

Rocky Mountain Regional VA Medical Center, Aurora, CO

Recruiting

Aurora, Colorado, United States, 80045-7211

Contacts

Kristina T Legget, PhD

(720) 724-5809kristina.legget@va.gov

Principal Investigator:

Kristina T. Legget, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Oct 5, 2026

Last verified

Sep, 2026

Keywords

  • Overweight
  • Obesity
  • Stress
  • Eating

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.