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

NCT ID: NCT06627569

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2030-08-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Overweight/Obesity Stress

Keywords

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Overweight Obesity Stress Eating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The investigator and outcomes assessors will not know the group assignment of participants.

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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

Interventions

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Exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristina T. Legget, PhD

Role: PRINCIPAL_INVESTIGATOR

Rocky Mountain Regional VA Medical Center, Aurora, CO

Locations

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Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

Site Status

Countries

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United States

Central Contacts

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Kristina T Legget, PhD

Role: CONTACT

Phone: (720) 724-5809

Email: [email protected]

Facility Contacts

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Kristina T Legget, PhD

Role: primary

Other Identifiers

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I01CX002752

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ENDA-009-24S

Identifier Type: -

Identifier Source: org_study_id