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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: Assessments and Diet Intake; Other: Diet Intervention

• Registration Number: NCT02031848
• Lead Sponsor: Cary Savage, Ph.D.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2014-01
• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-07
• Last Update Submitted: 2014-01-07
• Study First Posted: 2014-01-09
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Weight Control Group	Assessments and Diet Intake	Subjects will complete the Assessments, Diet Intake, and MRI portions of the study
Dieting Group	Diet Intervention	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

Primary Outcome Measures

Name	Time	Method
Differences in brain activation to visual food cues	Change from Baseline to 3 Months	differences will be measured by scanning subjects with fMRI and measuring changes in different regions of the brain.

Trial Locations

Locations (2)

University of Kansas; 🇺🇸 Lawrence, Kansas, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States