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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031848
• Other study ID #: 11123
• Status: Completed
• Phase: N/A
• First received: January 7, 2014
• Last updated: January 7, 2014
• Start date: September 2008
• Est. completion date: February 2012

Study information

• Verified date: January 2014
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Other:
• Diet Intervention

• Assessments and Diet Intake

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Kansas	Lawrence	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Cary Savage, Ph.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline to 3 Months	No