Clinical trial NCT02031848: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: weight loss
diet
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 137
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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.)

Primary outcomes:
measure: Differences in brain activation to visual food cues
timeFrame: Change from Baseline to 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lawrence
country: United States
facility: University of Kansas
state: Kansas
Study officials:
References:
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.
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.