An interventional study of Exercise in Overweight/Obesity and Stress, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Other
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.
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's planned enrollment of 132 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
12 weeks of aerobic exercise, with 4 sessions per week.
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.
Time frame: 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).
Time frame: Baseline, 12 weeks
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).
Time frame: Baseline, 12 weeks
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.
Time frame: Baseline, 12 weeks
Percent change in body weight
Percent change in body weight (kilograms) from baseline to after the 12-week intervention period.
Time frame: Baseline, 12 weeks
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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