Brain Function Predictors And Outcome Of Weight Loss And Weight Loss Maintenance

NCT ID: NCT02031848

Last Updated: 2014-01-09

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

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-02-29

Brief Summary

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By doing this study, researchers hope to learn whether a person's motivation for food is different after he or she loses weight, and if imaging techniques such as fMRI can be used to predict whether the person will maintain that weight loss over time.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy Weight Control Group

Subjects will complete the Assessments, Diet Intake, and MRI portions of the study

Group Type ACTIVE_COMPARATOR

Assessments and Diet Intake

Intervention Type OTHER

Dieting Group

Subjects will complete the Assessments, Diet Intake, and MRI portions of the study and will be given the weight loss and weight maintenance diets, and will attend weekly behavioral meetings

Group Type ACTIVE_COMPARATOR

Diet Intervention

Intervention Type OTHER

Interventions

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Diet Intervention

Intervention Type OTHER

Assessments and Diet Intake

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BMI equal to or greater than 30 kg/m2 or 18 to 24.9
* declaration they do not have plans to move out of the Greater Kansas City area for at least 1 year
* willingness to be randomized
* Individuals undergoing weight loss will have to present written approval from a licensed physician that they are healthy enough to participate in a program of moderate diet restriction and moderate physical activity.

Exclusion Criteria

* Participation in a research project involving weight loss or PA in the previous 6 months, as these proximal experiences may impact the results of this study.
* Subjects who smoke
* Subjects who use special diets (i.e. vegetarian, Adkins, etc.), use medications that affect metabolism (i.e. thyroid, beta blockers), use medications that affect appetite (i.e. Meridia) or cannot exercise (i.e. walk).
* Exhibit signs of eating disorders, restraint, depression
* Participant has any metabolic disease that would affect energy balance (e.g. diabetes mellitus or hypothyroidism).
* Individuals who report being pregnant during the previous 6 months, are lactating, or planned pregnancy within 12 months
* Individuals who are not weight stable (± 4.5kg) within the previous 3 months or have more than 500 kcal/wk of planned physical activity
* Serious medical risk such as type 1 diabetes, cancer, recent cardiac event (i.e. heart attack, angioplasty, etc.)
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cary Savage, Ph.D.

OTHER

Sponsor Role lead

Responsible Party

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Cary Savage, Ph.D.

Director, CHBN and John H. Wineinger Professor of Psychiatry and Behavioral Sciences

Responsibility Role SPONSOR_INVESTIGATOR

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

References

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Honea RA, Szabo-Reed AN, Lepping RJ, Perea R, Breslin F, Martin LE, Brooks WM, Donnelly JE, Savage CR. Voxel-based morphometry reveals brain gray matter volume changes in successful dieters. Obesity (Silver Spring). 2016 Sep;24(9):1842-8. doi: 10.1002/oby.21551. Epub 2016 Jul 19.

Reference Type DERIVED
PMID: 27430417 (View on PubMed)

Szabo-Reed AN, Breslin FJ, Lynch AM, Patrician TM, Martin LE, Lepping RJ, Powell JN, Yeh HW, Befort CA, Sullivan D, Gibson C, Washburn R, Donnelly JE, Savage CR. Brain function predictors and outcome of weight loss and weight loss maintenance. Contemp Clin Trials. 2015 Jan;40:218-31. doi: 10.1016/j.cct.2014.12.008. Epub 2014 Dec 19.

Reference Type DERIVED
PMID: 25533729 (View on PubMed)

Other Identifiers

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11123

Identifier Type: -

Identifier Source: org_study_id

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