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

Primary Purpose

Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Diet Intervention

Assessments and Diet Intake

About this trial

This is an interventional basic science trial for Obesity focused on measuring weight loss, diet

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

University of Kansas Medical Center
University of Kansas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Healthy Weight Control Group

Dieting Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Differences in brain activation to visual food cues

differences will be measured by scanning subjects with fMRI and measuring changes in different regions of the brain.

Secondary Outcome Measures

Full Information

NCT ID

NCT02031848

First Posted

January 7, 2014

Last Updated

January 7, 2014

Sponsor

Cary Savage, Ph.D.

1. Study Identification

Unique Protocol Identification Number

NCT02031848

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Cary Savage, Ph.D.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

weight loss, diet

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

137 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy Weight Control Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Dieting Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Diet Intervention

Intervention Type

Other

Intervention Name(s)

Assessments and Diet Intake

Primary Outcome Measure Information:

Title

Differences in brain activation to visual food cues

Description

differences will be measured by scanning subjects with fMRI and measuring changes in different regions of the brain.

Time Frame

Change from Baseline to 3 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.)

Facility Information:

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

University of Kansas

City

Lawrence

State/Province

Kansas

ZIP/Postal Code

66045

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27430417

Citation

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.

Results Reference

derived

PubMed Identifier

25533729

Citation

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.

Results Reference

derived

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

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