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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801254
• Other study ID #: RSRB00043988
• Status: Completed
• Phase: Phase 1
• First received: February 26, 2013
• Last updated: April 29, 2015
• Start date: February 2013
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2015
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Health Behavior
• Obesity
• Type II Diabetes

Intervention

Other:
• STRIDES
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 Control
Brain-computer interface training protocol that is designed to have no effect on self-controlled behavior.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postprandial blood glucose and triglycerides		4 times per week for 4 weeks	No