ObesityNCT02047721
The Effects of Exercise on Appetite Regulation in Overweight/Obese Individuals
A study testing Exercise and Diet in people with Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
In this study the Investigators are examining the effects of a 12-week exercise program (intervention) on measures of appetite and food intake regulation in overweight to mildly obese healthy adults. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise and Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 19 Jun 2019
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- all ethnic groups and both genders;
- age: 21-45 yrs;
- BMI: 27-35;
- weight stable within +/- 5 percent in the last 6 months;
- sedentary (less than 1 hour of planned physical activity by self-report).
Who cannot join
- history of cardiovascular disease (CVD), diabetes mellitus, uncontrolled hypertension, untreated thyroid disease, renal disease, hepatic disease, or any other medical condition affecting weight or energy metabolism;
- unable to effectively exercise due to cardiac, pulmonary, neurologic or orthopedic reasons;
- unable to pass screening graded exercise treadmill test;
- currently smoking;
- medications affecting weight, Energy Intake (EI) or Energy Expenditure (EE) in the last 6 months;
- weight loss or weight gain of >5 percent in past 6 months;
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- currently pregnant, lactating or less than 6 months post-partum;
- bariatric surgery;
- major psychiatric disorder, presence of alcohol or substance abuse, current depression by history and/or a score >21 on the he Center for Epidemiologic Studies Depression Scale (CES-D), history of eating disorders and/or a score of >20 on the EATS-26;
- contraindication to MRI
Trial locations and contacts
1 site in 1 country.
About this study
In this study the Investigators are examining the effects of a 12-week exercise program (intervention) on measures of appetite and food intake regulation in overweight to mildly obese healthy adults. The Investigators hypothesize that individuals who lose a significant amount of weight in response to the intervention will show a reduction in the brain response to food cues as measured by functional magnetic resonance imaging (fMRI) when compared to those who do not lose weight. These changes in neuronal activity will be associated to physiologic and behavioral measures.
- Conditions
- Obesity
- Being tested
- Exercise, Diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
The intervention gradually increases EE from 150-200 kcal/day 5 days per week to a target of 400 kcal/d 5 days per week and will last a total of 12 weeks.
DietBehavioural
A supervised diet program which has been successfully implemented by our group with a goal being to reduce energy intake by ~2000 kcal/week.
| Study group | Role | What they receive |
|---|---|---|
| Physical Intervention | Experimental | A supervised exercise program Receives: Behavioral: Exercise |
| Nutritional Intervention | Experimental | A supervised diet program Receives: Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI Response to Visual Food Cues
The neuronal response will be assessed by functional magnetic resonance imaging (fMRI) in response to visual food cues
Blood oxygen dependent signal (BOLD) response in exposure to visual food cues will be measured during a fMRI scan and the difference between responses in those who lose weight vs. those who do not lose weight will be compared.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completion19 Jun 2019
- Study completion19 Jun 2019
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 Colorado, DenverThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Kristina Legget, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047721
- Sponsor's protocol ID
- 13-3252
- Other IDs
- UL1TR001082
- Status last verified
- Oct 2020
- First submitted
- 15 Jan 2014
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise on Appetite Regulation in Overweight/Obese Individuals
- ClinicalTrials.gov ID
- NCT02047721
- Acronym / sponsor ID
- 13-3252
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Feb 2014
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 28 Jan 2014 (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.
In this study the Investigators are examining the effects of a 12-week exercise program (intervention) on measures of appetite and food intake regulation in overweight to mildly obese healthy adults. The Investigators hypothesize that individuals who lose a significant amount of weight in response to the intervention will show a reduction in the brain response to food cues as measured by functional magnetic resonance imaging (fMRI) when compared to those who do not lose weight. These changes in neuronal activity will be associated to physiologic and behavioral measures.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Intervention | Experimental | Behavioral: ExerciseA supervised exercise program |
| Nutritional Intervention | Experimental | Behavioral: DietA supervised diet program |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- all ethnic groups and both genders;
- age: 21-45 yrs;
- BMI: 27-35;
- weight stable within +/- 5 percent in the last 6 months;
- sedentary (less than 1 hour of planned physical activity by self-report).
Key exclusion criteria (10 listed)
- history of cardiovascular disease (CVD), diabetes mellitus, uncontrolled hypertension, untreated thyroid disease, renal disease, hepatic disease, or any other medical condition affecting weight or energy metabolism;
- unable to effectively exercise due to cardiac, pulmonary, neurologic or orthopedic reasons;
- unable to pass screening graded exercise treadmill test;
- currently smoking;
- medications affecting weight, Energy Intake (EI) or Energy Expenditure (EE) in the last 6 months;
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 |
|---|---|---|
| ExerciseThe intervention gradually increases EE from 150-200 kcal/day 5 days per week to a target of 400 kcal/d 5 days per week and will last a total of 12 weeks. | Behavioural | Physical Intervention |
| DietA supervised diet program which has been successfully implemented by our group with a goal being to reduce energy intake by ~2000 kcal/week. | Behavioural | Nutritional Intervention |
Primary outcome
fMRI Response to Visual Food Cues
Time frame: 12 weeks
The neuronal response will be assessed by functional magnetic resonance imaging (fMRI) in response to visual food cues Blood oxygen dependent signal (BOLD) response in exposure to visual food cues will be measured during a fMRI scan and the difference between responses in those who lose weight vs. those who do not lose weight will be compared.
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 22 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Kristina Legget, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Diet in people with Obesity, run by University of Colorado, Denver at 1 site 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 10 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
fMRI Response to Visual Food Cues (time frame: 12 weeks). 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 22 Oct 2020.