Exercise Effects on the Neurobiology Underlying Stress-related Eating Behaviors in Veterans
2 other identifiers
interventional
132
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2024
CompletedFirst Posted
Study publicly available on registry
October 4, 2024
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2030
Study Completion
Last participant's last visit for all outcomes
August 30, 2030
May 7, 2026
May 1, 2026
4.2 years
October 3, 2024
May 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 (mcg/dL) throughout a counting task involving mental math (measured as area under the curve).
Baseline, 12 weeks
Secondary Outcomes (1)
Change in heart rate response to counting task
Baseline, 12 weeks
Other Outcomes (2)
Change in percent body fat
Baseline, 12 weeks
Percent change in body weight
Baseline, 12 weeks
Study Arms (2)
Exercise
EXPERIMENTALParticipants 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.
Usual activity
NO INTERVENTIONParticipants 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
Eligibility Criteria
You may qualify if:
- Veterans 18-75 years old
- BMI of 25 or greater
- Physically inactive
- Able to attend study visits in person in Aurora, CO
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristina T. Legget, PhD
Rocky Mountain Regional VA Medical Center, Aurora, CO
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The investigator and outcomes assessors will not know the group assignment of participants.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2024
First Posted
October 4, 2024
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
August 30, 2030
Study Completion (Estimated)
August 30, 2030
Last Updated
May 7, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will become available after publication of study results and be available at least 3 years beyond the completion of the study.
- Access Criteria
- Data will be made available upon request for general research purposes, based on availability of resources.
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.