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

NCT01801254 | Completed Phase 1

• 1 other identifier: RSRB00043988
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• postprandial blood glucose and triglycerides

  4 times per week for 4 weeks

Study Arms (2)

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.

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.

Other: Sham Control

Interventions

STRIDES OTHER

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.

STRIDES

Sham Control OTHER

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

Sham Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14627, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Health Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Jordan Silberman, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Student

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: February 28, 2013
• Study Start: February 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: February 1, 2015
• Last Updated: April 30, 2015

Record last verified: 2015-04

Locations

US (1)