ObesityPhase 1NCT01801254
Using EEG Operant Conditioning to Improve Trait Self-Control and Promote Healthy Behavior
A Phase 1 study testing STRIDES in people with Obesity and Type II Diabetes, run by University of Rochester at 1 site in United States.
Trial summary
The field of neuroeconomics has begun to elucidate neural mechanisms underlying self-control; however, researchers have not yet harnessed neuroeconomics findings to develop interventions for improving self-control ability. The investigators are currently developing such an intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type II Diabetes, Cardiovascular Disease
- What is being tested?
- STRIDES
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Feb 2015
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Can read and write fluently in English
- At least 18 years of age
- Right-handed
- Overweight or obese (BMI > 24.9)
- Currently has a University of Rochester meal plan
- Currently in contemplation or action stages of change with respect to weight loss (measured with the Weight Stages of Change Algorithm; Rossi, Rossi, Velicer, \& Prochaska, 1995).
Who cannot join
- History of diabetes, epilepsy, celiac disease, lactose intolerance, food allergies, veganism, mental illness, or eating disorders
- Currently taking a medication that may have a strong effect on EEG recordings (eg, an antidepressant, stimulant medication, etc.)
- Currently drinks more than 3 cups of coffee per day or roughly equivalent caffeine intake
Trial locations and contacts
1 site in 1 country.
About this study
The field of neuroeconomics has begun to elucidate neural mechanisms underlying self-control; however, researchers have not yet harnessed neuroeconomics findings to develop interventions for improving self-control ability. The investigators are currently developing such an intervention. The investigators' approach involves using a brain-computer interface with audiovisual feedback to show people what is happening in their own brains, in real time. Through this interface, individuals are trained to increase levels of neural activity that may facilitate self-control, which, in turn, may improve the ability to exhibit self-controlled behaviors. This may increase the ability to engage in heath behaviors for which self-control is required (eg, dieting and exercising). The investigators' long-term goal is to create a tool that will help people develop the self-control needed to achieve lasting improvements in health behaviors.
- Conditions
- Obesity, Type II Diabetes, Cardiovascular Disease, Health Behavior
- Being tested
- STRIDES, Sham Control
- Keywords
- Obesity, Type II diabetes, Cardiovascular disease, Health behavior promotion, Neuroeconomics, EEG biofeedback, Low-resolution electromagnetic tomography (LORETA), EEG
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRIDESOther
Self-Control TRaining for Increasing Delay of gratification through EEG operant conditioning with Source localization (STRIDES). Brain-computer interface training protocol designed to up-regulate specific types of neural activity, in regions including the left dorsolateral prefrontal cortex, the anterior cingulate cortex, and Brodmann area 6 bilaterally. Targeted neural activity types are positively associated with self-controlled behavior.
Sham ControlOther
Brain-computer interface training protocol that is designed to have no effect on self-controlled behavior.
| Study group | Role | What they receive |
|---|---|---|
| STRIDES | Experimental | Brain-computer interface training protocol designed to up-regulate specific types of neural activity in regions including the left dorsolateral prefrontal cortex, the anterior cingulate cortex, and Brodmann area 6 bilaterally. Targeted neural activity types are positively associated with self-controlled behavior. Receives: Other: STRIDES |
| Sham Control | Sham comparator | Brain-computer interface training protocol that is designed to have no effect on self-controlled behavior. Stimuli used and durations of training sessions for this protocol are identical to those used in the treatment condition. Receives: Other: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial blood glucose and triglycerides
Measured: 4 times per week for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2013
- Study completionFeb 2015
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.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordan Silberman, University of Rochester
- Investigators
- Jordan Silberman, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801254
- Sponsor's protocol ID
- RSRB00043988
- Status last verified
- Apr 2015
- First submitted
- 26 Feb 2013
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using EEG Operant Conditioning to Improve Trait Self-Control and Promote Healthy Behavior
- ClinicalTrials.gov ID
- NCT01801254
- Acronym / sponsor ID
- RSRB00043988
- Conditions
- Obesity, Type II Diabetes, Cardiovascular Disease, Health Behavior
- Keywords
- Obesity, Type II diabetes, Cardiovascular disease, Health behavior promotion, Neuroeconomics, EEG biofeedback, Low-resolution electromagnetic tomography (LORETA), EEG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 28 Feb 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.
The field of neuroeconomics has begun to elucidate neural mechanisms underlying self-control; however, researchers have not yet harnessed neuroeconomics findings to develop interventions for improving self-control ability. The investigators are currently developing such an intervention. The investigators' approach involves using a brain-computer interface with audiovisual feedback to show people what is happening in their own brains, in real time. Through this interface, individuals are trained to increase levels of neural activity that may facilitate self-control, which, in turn, may improve the ability to exhibit self-controlled behaviors. This may increase the ability to engage in heath behaviors for which self-control is required (eg, dieting and exercising). The investigators' long-term goal is to create a tool that will help people develop the self-control needed to achieve lasting improvements in health behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STRIDES | Experimental | Other: STRIDESBrain-computer interface training protocol designed to up-regulate specific types of neural activity in regions including the left dorsolateral prefrontal cortex, the anterior cingulate cortex, and Brodmann area 6 bilaterally. Targeted neural activity types are positively associated with self-controlled behavior. |
| Sham Control | Sham comparator | Other: Sham ControlBrain-computer interface training protocol that is designed to have no effect on self-controlled behavior. Stimuli used and durations of training sessions for this protocol are identical to those used in the treatment condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Can read and write fluently in English
- At least 18 years of age
- Right-handed
- Overweight or obese (BMI > 24.9)
- Currently has a University of Rochester meal plan
Key exclusion criteria (3 listed)
- History of diabetes, epilepsy, celiac disease, lactose intolerance, food allergies, veganism, mental illness, or eating disorders
- Currently taking a medication that may have a strong effect on EEG recordings (eg, an antidepressant, stimulant medication, etc.)
- Currently drinks more than 3 cups of coffee per day or roughly equivalent caffeine intake
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 |
|---|---|---|
| STRIDESSelf-Control TRaining for Increasing Delay of gratification through EEG operant conditioning with Source localization (STRIDES). Brain-computer interface training protocol designed to up-regulate specific types of neural activity, in regions including the left dorsolateral prefrontal cortex, the anterior cingulate cortex, and Brodmann area 6 bilaterally. Targeted neural activity types are positively associated with self-controlled behavior. | Other | STRIDES |
| Sham ControlBrain-computer interface training protocol that is designed to have no effect on self-controlled behavior. | Other | Sham Control |
Primary outcome
postprandial blood glucose and triglycerides
Time frame: 4 times per week for 4 weeks
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 30 Apr 2015.
Related trials for Obesity
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Recruiting
Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Effect of Exercise Training on Breastmilk Composition
Obesity
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
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.
Jordan Silberman, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STRIDES in people with Obesity and Type II Diabetes, run by University of Rochester 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 6 inclusion and 3 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 30 Apr 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
postprandial blood glucose and triglycerides (time frame: 4 times per week for 4 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 30 Apr 2015; AzTrials last refreshed its copy on 27 Oct 2026.