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Using EEG Operant Conditioning to Improve Trait Self-Control and Promote Healthy Behavior

Primary Purpose

Obesity, Type II Diabetes, Cardiovascular Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

STRIDES

Sham Control

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Type II diabetes, Cardiovascular disease, Health behavior promotion, Neuroeconomics, EEG biofeedback, Low-resolution electromagnetic tomography (LORETA), EEG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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

Sites / Locations

University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

STRIDES

Sham Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

postprandial blood glucose and triglycerides

Secondary Outcome Measures

Full Information

NCT ID

NCT01801254

First Posted

February 26, 2013

Last Updated

April 29, 2015

Sponsor

University of Rochester

1. Study Identification

Unique Protocol Identification Number

NCT01801254

Brief Title

Using EEG Operant Conditioning to Improve Trait Self-Control and Promote Healthy Behavior

Official Title

Using EEG Operant Conditioning to Improve Trait Self-Control and Promote Healthy Behavior

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

STRIDES

Arm Type

Experimental

Arm Description

Arm Title

Sham Control

Arm Type

Sham Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

STRIDES

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Sham Control

Intervention Description

Brain-computer interface training protocol that is designed to have no effect on self-controlled behavior.

Primary Outcome Measure Information:

Title

postprandial blood glucose and triglycerides

Time Frame

4 times per week for 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jordan Silberman, PhD

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14627

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Using EEG Operant Conditioning to Improve Trait Self-Control and Promote Healthy Behavior

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