Neuroimaging Study of Factors Related to Exercise

NCT ID: NCT02010463

Last Updated: 2020-03-25

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

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2020-01-15

Brief Summary

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This study aims to support the hypothesis that brain processes underlying reward processing and impulse control contribute to obesity and to adherence in a new exercise regimen.

Detailed Description

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This is a nonrandomized trial with groups being defined by BMI and adherence status to the exercise intervention.

Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Exercise Intervention

9-month exercise program involving four exercise education sessions

Group Type OTHER

Exercise

Intervention Type OTHER

Interventions

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Exercise

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BMI \>25 to \< 40±1
* Must live in the Greater Kansas City area for at least 1 year
* Willing to exercise
* Provide written approval from a licensed physician that they are healthy enough to participate in a program of moderate physical activity and maximum O2 testing
* All participants must be sedentary except for casual recreation such as softball, bowling, etc.

Exclusion Criteria

* Color-blindness
* Left-handedness
* Any diagnosed neurological disorder or conditions that preclude MRI scanning (e.g., metal in body)
* Participation in a research project involving weight loss or physical activity in the previous 6 months
* Subjects who smoke
* Subjects use medications that affect metabolism (i.e. thyroid, beta blockers), use medications that affect appetite (i.e. Meridia) or cannot exercise (i.e. walk)
* Participants will be excluded by study personnel following interview if they exhibit eating disorders, binge eating, depression or drug addiction
* Metabolic disease that would affect energy balance (e.g. diabetes mellitus or hypothyroidism)
* Pregnant during the previous 6 months, are lactating, or plan pregnancy within 12 months
* Individuals who are not weight stable (± 4.5kg) within the previous year.
* Serious medical risks such as type 1-diabetes, cancer, recent cardiac event (i.e. heart attack, angioplasty, etc.)
* High blood pressure
* Current use of smoking/tobacco products or initiation of the use of smoking/tobacco products during the study and alcohol abuse and any history of dependence
* Subject IQ is less that 80
* Reported radiation exposure from CT, PET, fluoroscopic or nuclear medicine studies within the previous year, or other radiation exposure at the discretion of the PI
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Joseph Donnelly

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cary Savage, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

University of Kansas

Lawrence, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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5R01DK085605

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R01DK085605-04

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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