NCT02010463

Brief Summary

This study aims to support the hypothesis that brain processes underlying reward processing and impulse control contribute to obesity and to adherence in a new exercise regimen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Oct 2011

Longer than P75 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

October 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

8.3 years

First QC Date

December 9, 2013

Last Update Submit

March 23, 2020

Conditions

Obesity

Keywords

reward processingimpulse controlobeseclinically obese

Outcome Measures

Primary Outcomes (1)

  • Body weight and body composition

    Body weights will be recorded using a digital scale accurate to + 0.1 kg (Befour Inc Model #PS6600, Saukville, WI). Participants will report to the Center between 7 and 10 AM and will be weighed prior to breakfast and after attempting to void. Participants will wear a standard hospital gown at the time of weighing.

    Change from Baseline to 9 months

Secondary Outcomes (5)

  • Body weight and body composition

    Change from Baseline to 4 Months

  • Treadmill testing for maximum oxygen consumption

    Change from Baseline to 4 Months

  • Treadmill testing for maximum oxygen consumption

    Change from Baseline to 9 Months

  • Measurement of Energy Intake

    Change from Baseline to 4 Months

  • Measurement of Energy Intake

    Change from Baseline to 9 Months

Study Arms (1)

Exercise Intervention

OTHER

9-month exercise program involving four exercise education sessions

Other: Exercise

Interventions

ExerciseOTHER
Exercise Intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \>25 to \< 40±1
  • Must live in the Greater Kansas City area for at least 1 year
  • Willing to exercise
  • Provide written approval from a licensed physician that they are healthy enough to participate in a program of moderate physical activity and maximum O2 testing
  • All participants must be sedentary except for casual recreation such as softball, bowling, etc.

You may not qualify if:

  • Color-blindness
  • Left-handedness
  • Any diagnosed neurological disorder or conditions that preclude MRI scanning (e.g., metal in body)
  • Participation in a research project involving weight loss or physical activity in the previous 6 months
  • Subjects who smoke
  • Subjects use medications that affect metabolism (i.e. thyroid, beta blockers), use medications that affect appetite (i.e. Meridia) or cannot exercise (i.e. walk)
  • Participants will be excluded by study personnel following interview if they exhibit eating disorders, binge eating, depression or drug addiction
  • Metabolic disease that would affect energy balance (e.g. diabetes mellitus or hypothyroidism)
  • Pregnant during the previous 6 months, are lactating, or plan pregnancy within 12 months
  • Individuals who are not weight stable (± 4.5kg) within the previous year.
  • Serious medical risks such as type 1-diabetes, cancer, recent cardiac event (i.e. heart attack, angioplasty, etc.)
  • High blood pressure
  • Current use of smoking/tobacco products or initiation of the use of smoking/tobacco products during the study and alcohol abuse and any history of dependence
  • Subject IQ is less that 80
  • Reported radiation exposure from CT, PET, fluoroscopic or nuclear medicine studies within the previous year, or other radiation exposure at the discretion of the PI

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

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Cary Savage, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 12, 2013

Study Start

October 1, 2011

Primary Completion

December 30, 2019

Study Completion

January 15, 2020

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

US(2)