Computerized Response Training Obesity Treatment (CC)

September 22, 2023 updated by: Oregon Research Institute

Translational Neuroscience: Response Training for Obesity Treatment

This project will test whether a food response training intervention produces lasting body fat loss, use objective brain imaging to examine the mechanism of effect of this treatment and investigate the generalizability of the training to non-training foods, and examine factors that should amplify intervention effects to provide a test of the intervention theory. This novel treatment represents a bottom-up implicit training intervention that does not rely on executive control, prolonged caloric deprivation, and expensive clinicians to deliver, like behavioral weight loss treatments that have not produced lasting weight loss. If this computer-based response training intervention produces sustained body fat loss in overweight individuals, it could be easily implemented very broadly at almost no expense, addressing a leading public health problem.

Study Overview

Detailed Description

Obesity causes 300,000 US deaths yearly, but most treatments do not result in lasting weight loss. People who show greater brain reward and attention region response, and less inhibitory region response, to high-calorie food images/cues show elevated future weight gain, consistent with the theory that overeating results from a strong approach response to high-calorie food cues paired with a weak inhibitory response. This implies that an intervention that reduces reward and attention region response to such food and increases inhibitory control region response should reduce overeating that is rooted in exposure to pervasive food cues. Computer-based response-inhibition training with high-calorie foods has decreased attentional bias for and intake of the training food, increased inhibitory control, and produced weight loss in overweight participants in 3 proof-of-concept trials, with effects persisting through 6-mo follow-up. A pilot trial found that overweight/obese adults who completed a multi-faceted 4-hr response-inhibition training with high-calorie food images and response-facilitation training with low-calorie food images showed reduced fMRI-assessed reward and attention region response to high-calorie training foods and greater body fat loss than controls who completed a rigorous 4-hr generic response-inhibition/response-facilitation training with non-food images (d=.95), producing a 7% reduction in excess body fat over the 4-wk period. The investigators propose to evaluate a refined and extended version of this response-training intervention.

Aim 1: Randomize 180 overweight/obese adults to a 4-wk response training obesity treatment or a generic inhibition training control condition that both include bi-monthly Internet-delivered booster training for a year and a smart phone response training app that can be used when tempted by high-calorie foods, assessing outcomes at pre, post, and at 3-, 6-, and 12-month follow-ups (e.g., % body fat, the primary outcome).

Aim 2: Use fMRI to test whether reduced reward and attention region response, and increased inhibitory region response to high-calorie food images used and not used in the response training mediate the effects of the intervention on fat loss. The investigators will also test whether during training participants show acute reductions in reward and attention region response, and increases in inhibitory response to high-calorie training food images to capture the learning process, assess generalizability of the intervention to food images not used in training, and collect behavioral data on mediators.

Aim 3: Test whether intervention effects will be stronger for those who show less inhibitory control in response to high-calorie food images, a genetic propensity for greater dopamine signaling in reward circuitry, and greater pretest reward and attention region response, and weaker inhibitory region response to high-calorie food images, based on the theory that response training is more efficacious for those with a strong pre-potent approach tendency to high-calorie foods.

During the Covid-19 shelter-at-home order, we will not measure in person only outcomes including BodPod assessments, height and weight measurement for BMI calculation, electrocardiogram (ECG) assessments and fMRI scanning for all participants that have assessments due during this order.

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oregon
      • Eugene, Oregon, United States, 97403
        • Oregon Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Body Mass Index Between 25 and 35

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Condition
Participants will complete computer based response training tasks that will incorporate pictures of birds, flowers, and mammals. As part of the computer based training, participants will be instructed to respond or inhibit response to certain of these stimuli in order to bring about a change in the participant response to certain stimuli. These tasks will be structured identically to those presented in the experimental condition, only the appearance and context of the stimuli will be different (i.e., non-food versus food items). The computer tasks described above comprise the Generic Response Training Control Intervention.
Participants complete four computer based training tasks each visit, over the course of a few lab visits. Participants then perform weekly booster sessions in a more natural home or community environment over the internet using the same computer based training tasks.
Experimental: Experimental Condition
Participants will complete computer-based response training tasks that will incorporate pictures of healthy food, unhealthy food, and glasses of water. As part of the computer-based training, participants will be instructed to respond or inhibit responses to certain of these stimuli in order to bring about a change in the participant response to certain stimuli. These tasks will be structured identically to those presented in the control condition, only the appearance and context of the stimuli will be different (i.e., food versus non-food items). The computer tasks described above comprise the Computer Based Response Training Weight Loss Intervention. To optimize the intervention, we narrowed the low-calorie food stimulus set to make a better distinction between high-calorie and low-calorie foods and we changed the filler images (water and furry mammals) in the go/no-go task from 100% "go" to 50% "go" and 50% "no-go" to measure learning of stimulus-specific respond associations.
Participants complete four computer based training tasks each visit, over the course of a few lab visits. Participants then perform weekly booster sessions in a more natural home or community environment over the internet using the same computer based training tasks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Fat Change
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months
Change in participant's body fat percentage
Baseline, 1 month, 3 months, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Eating Disorder Symptoms
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months
Eating disorder symptoms as measured with the Eating Disorder Diagnostic Interview
Baseline, 1 month, 3 months, 6 months, 12 months
Dietary Restraint, Emotional Eating, and External Eating
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months
Change in Dietary Restraint, Emotional Eating, and External Eating (aggregate score) as measured by the Dutch Eating Behavior Questionnaire
Baseline, 1 month, 3 months, 6 months, 12 months
Change in Disinhibited Eating Behavior
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months
Chang in Disinhibited Eating as measured by the Three Factor Eating Questionnaire
Baseline, 1 month, 3 months, 6 months, 12 months
Change in Eating in the Absence of Hunger Behavior
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months
Change in Eating When Not Hungry as measured by the Eating in the Absence of Hunger Questionnaire
Baseline, 1 month, 3 months, 6 months, 12 months
Change in Food Addiction Behavior
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months
Change in Problematic eating patterns associated with symptoms of addictive behaviors as measured by the Yale Food Addiction Scale
Baseline, 1 month, 3 months, 6 months, 12 months
Change in Physical Activity
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months
Change in Physical Activity as measured by the Paffenberger Questionnaire
Baseline, 1 month, 3 months, 6 months, 12 months
Change in Alcohol Use Behavior
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months
Change in Substance use frequency (i.e., number of times per day) for alcohol of participants as measured by the Daily Drinking Questionnaire
Baseline, 1 month, 3 months, 6 months, 12 months
Change in Substance Use Behavior
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months
Change in Substance use frequency (i.e., number of times per day) for common recreational drugs of participants as measured by the Daily Drug Taking Questionnaire
Baseline, 1 month, 3 months, 6 months, 12 months
Change in Participant Ratings of Unhealthy Food Palatability
Time Frame: Baseline, 1 month
Change in Participant behavioral response to food pictures, and subjective palatability rating
Baseline, 1 month
Change in Participant Ratings of Food Monetary Value
Time Frame: Baseline, 1 month
Change in Participant behavioral response to food pictures, and willingness to pay given dollar amounts (aggregate score) for the pictured food
Baseline, 1 month
Change in Food Craving and Liking Behavior
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months
Change Participant food craving behaviors as measured by the Food Craving and Liking Scale
Baseline, 1 month, 3 months, 6 months, 12 months
Change in Body Mass Index
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months
Change in Participant BMI using standard methods of calculation
Baseline, 1 month, 3 months, 6 months, 12 months
Change in mean R-Peak Amplitude
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months
Change in mean R-Peak Amplitude measured using three-lead ECG using PowerLab 8 Diagnostic Suite
Baseline, 1 month, 3 months, 6 months, 12 months
Change in Heart Rate Variability
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months
Change in Heart Rate Variability measured using three-lead ECG using PowerLab 8 Diagnostic Suite
Baseline, 1 month, 3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eric Stice, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2017

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

December 14, 2017

First Posted (Actual)

December 18, 2017

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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