NCT02031848

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

3.4 years

First QC Date

January 7, 2014

Last Update Submit

January 7, 2014

Conditions

Obesity

Keywords

weight lossdiet

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Healthy Weight Control Group

ACTIVE COMPARATOR

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

Other: Assessments and Diet Intake

Dieting Group

ACTIVE COMPARATOR

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

Other: Diet Intervention

Interventions

Diet InterventionOTHER
Dieting Group
Assessments and Diet IntakeOTHER
Healthy Weight Control Group

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kansas

Lawrence, Kansas, 66045, United States

Location

Related Publications (2)

  • 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.

    PMID: 27430417DERIVED

  • 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.

    PMID: 25533729DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, CHBN and John H. Wineinger Professor of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 9, 2014

Study Start

September 1, 2008

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

US(2)