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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress; Overweight/Obesity
• Intervention / Treatment: Behavioral: Exercise

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 Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristina T Legget, PhD; Phone Number: (720) 724-5809; Email: kristina.legget@va.gov

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045-7211
      • Rocky Mountain Regional VA Medical Center, Aurora, CO
      • Contact: Kristina T Legget, PhD; Phone Number: (720) 724-5809; Email: kristina.legget@va.gov
      • Principal Investigator: Kristina T. Legget, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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.	Behavioral: Exercise; 12 weeks of aerobic exercise, with 4 sessions per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in blood oxygen level dependent (BOLD) response to visual food cues as measured by functional magnetic resonance imaging (fMRI)	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.	Baseline, 12 weeks
Change in serum cortisol response to counting task	Change from baseline to after the 12-week intervention period in serum cortisol levels (micrograms per deciliter (mcg/dL)) throughout a counting task involving mental math (measured as area under the curve).	Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate response to counting task	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).	Baseline, 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in percent body fat	Change in percent body fat, as measured by dual-energy x-ray absorptiometry, from baseline to after the 12-week intervention period.	Baseline, 12 weeks
Percent change in body weight	Percent change in body weight (kilogram (kg)) from baseline to after the 12-week intervention period.	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Kristina T. Legget, PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 30, 2030
• Study Completion (Estimated): August 30, 2030

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): August 24, 2026
• Last Update Submitted That Met QC Criteria: August 20, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Stress; Overweight; Eating
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: ENDA-009-24S; I01CX002752 (U.S. NIH Grant/Contract: Department of Veterans Affairs)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: As some journals now require authors to provide access to data, de-identified, anonymized data sets will be created after study results are published, and made available upon request for general research purposes, based on availability of resources. No proprietary data will be made publicly available. Sufficient data and descriptors will be made available to confirm conclusions in resulting publications and duplicate statistical analyses.
• IPD Sharing Time Frame: Data will become available after publication of study results and be available at least 3 years beyond the completion of the study.
• IPD Sharing Access Criteria: Data will be made available upon request for general research purposes, based on availability of resources.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No