ObesityNCT02010463
Neuroimaging Study of Factors Related to Exercise
A study testing Exercise in people with Obesity, run by University of Kansas Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2011to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Kansas
Lawrence, Kansas, 66045
About this study
Official title: Neuroimaging Studies of Reward, Impulsivity, and Adherence to an Exercise Program
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.
Read the detailed description
This is a nonrandomized trial with groups being defined by BMI and adherence status to the exercise intervention.
- Conditions
- Obesity
- Being tested
- Exercise
- Keywords
- reward processing, impulse control, obese, clinically obese
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Other | 9-month exercise program involving four exercise education sessions Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to 9 months
Secondary outcomes (5)
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.
Measured: Change from Baseline to 4 Months
Treadmill testing for maximum oxygen consumption
Participants will undergo a physician supervised maximal treadmill test to assess changes in maximal oxygen consumption. Furthermore, maximal heart rate obtained from the baseline test will be used to target the appropriate exercise intensity. Participants will walk at 3.4 mph beginning at 0% grade. The grade will be increased 2.5% at 2 minute intervals until exhaustion occurs. Heart rates will be recorded at one minute intervals with a multiple channel electrocardiograph. Expired air will be measured for oxygen and carbon dioxide at 20-second intervals using a ParvoMedics TrueOne 2400 indirect calorimetry system. The system will be and calibrated before each test according to the specifications of the manufacturer (ParvoMedics, Inc Sandy, Utah). Maximal oxygen consumption will be considered as the highest observed value (American College of Sports Medicine 2000).
Measured: Change from Baseline to 4 Months
Treadmill testing for maximum oxygen consumption
Participants will undergo a physician supervised maximal treadmill test to assess changes in maximal oxygen consumption. Furthermore, maximal heart rate obtained from the baseline test will be used to target the appropriate exercise intensity. Participants will walk at 3.4 mph beginning at 0% grade. The grade will be increased 2.5% at 2 minute intervals until exhaustion occurs. Heart rates will be recorded at one minute intervals with a multiple channel electrocardiograph. Expired air will be measured for oxygen and carbon dioxide at 20-second intervals using a ParvoMedics TrueOne 2400 indirect calorimetry system. The system will be and calibrated before each test according to the specifications of the manufacturer (ParvoMedics, Inc Sandy, Utah). Maximal oxygen consumption will be considered as the highest observed value (American College of Sports Medicine 2000).
Measured: Change from Baseline to 9 Months
Measurement of Energy Intake
Participants will be asked not to alter their dietary intake during the intervention. Dietary intake will be documented from 3-day food records (2 weekdays, 1 weekend day). The nutrient content of the record data will be determined using Nutrition Data System for Research (NDS-R, version 2008, University of Minnesota, Minneapolis, MN).
Measured: Change from Baseline to 4 Months
Measurement of Energy Intake
Participants will be asked not to alter their dietary intake during the intervention. Dietary intake will be documented from 3-day food records (2 weekdays, 1 weekend day). The nutrient content of the record data will be determined using Nutrition Data System for Research (NDS-R, version 2008, University of Minnesota, Minneapolis, MN).
Measured: Change from Baseline to 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startOct 2011
- Primary completion30 Dec 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Donnelly, University of Kansas Medical Center
- Investigators
- Cary Savage, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010463
- Sponsor's protocol ID
- 5R01DK085605-04
- Other IDs
- 5R01DK085605
- Status last verified
- Mar 2020
- First submitted
- 9 Dec 2013
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Studies of Reward, Impulsivity, and Adherence to an Exercise Program
- ClinicalTrials.gov ID
- NCT02010463
- Acronym / sponsor ID
- 5R01DK085605-04
- Conditions
- Obesity
- Keywords
- reward processing, impulse control, obese, clinically obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2011 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a nonrandomized trial with groups being defined by BMI and adherence status to the exercise intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Other | Other: Exercise9-month exercise program involving four exercise education sessions |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise | Other | Exercise Intervention |
Primary outcome
Body weight and body composition
Time frame: Change from Baseline to 9 months
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.
5 secondary outcomes
Body weight and body composition
Time frame: Change from Baseline to 4 Months
Treadmill testing for maximum oxygen consumption
Time frame: Change from Baseline to 4 Months
Treadmill testing for maximum oxygen consumption
Time frame: Change from Baseline to 9 Months
Measurement of Energy Intake
Time frame: Change from Baseline to 4 Months
Measurement of Energy Intake
Time frame: Change from Baseline to 9 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cary Savage, PhD principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Obesity, run by University of Kansas Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight and body composition (time frame: Change from Baseline to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.