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Computerized Response Training Obesity Treatment (CC)

Primary Purpose

Obesity, Hyperphagia, Feeding and Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer Based Response Training Weight Loss Intervention
Generic Response Training Control Intervention
Sponsored by
Oregon Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Dissonance, Response Training, Eating Disorder, Computer-based Training

Eligibility Criteria

18 Years - 38 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body Mass Index Between 25 and 35

Exclusion Criteria:

Sites / Locations

  • Oregon Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Condition

Experimental Condition

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Body Fat Change
Change in participant's body fat percentage

Secondary Outcome Measures

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

Full Information

First Posted
May 17, 2017
Last Updated
September 22, 2023
Sponsor
Oregon Research Institute
Collaborators
Flinders University, University of Exeter, Radboud University Medical Center, University of Oregon
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1. Study Identification

Unique Protocol Identification Number
NCT03375853
Brief Title
Computerized Response Training Obesity Treatment
Acronym
CC
Official Title
Translational Neuroscience: Response Training for Obesity Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2017 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
September 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute
Collaborators
Flinders University, University of Exeter, Radboud University Medical Center, University of Oregon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hyperphagia, Feeding and Eating Disorders
Keywords
Obesity, Dissonance, Response Training, Eating Disorder, Computer-based Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Condition
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental Condition
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Computer Based Response Training Weight Loss Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Generic Response Training Control Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Fat Change
Description
Change in participant's body fat percentage
Time Frame
Baseline, 1 month, 3 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Change in Eating Disorder Symptoms
Description
Eating disorder symptoms as measured with the Eating Disorder Diagnostic Interview
Time Frame
Baseline, 1 month, 3 months, 6 months, 12 months
Title
Dietary Restraint, Emotional Eating, and External Eating
Description
Change in Dietary Restraint, Emotional Eating, and External Eating (aggregate score) as measured by the Dutch Eating Behavior Questionnaire
Time Frame
Baseline, 1 month, 3 months, 6 months, 12 months
Title
Change in Disinhibited Eating Behavior
Description
Chang in Disinhibited Eating as measured by the Three Factor Eating Questionnaire
Time Frame
Baseline, 1 month, 3 months, 6 months, 12 months
Title
Change in Eating in the Absence of Hunger Behavior
Description
Change in Eating When Not Hungry as measured by the Eating in the Absence of Hunger Questionnaire
Time Frame
Baseline, 1 month, 3 months, 6 months, 12 months
Title
Change in Food Addiction Behavior
Description
Change in Problematic eating patterns associated with symptoms of addictive behaviors as measured by the Yale Food Addiction Scale
Time Frame
Baseline, 1 month, 3 months, 6 months, 12 months
Title
Change in Physical Activity
Description
Change in Physical Activity as measured by the Paffenberger Questionnaire
Time Frame
Baseline, 1 month, 3 months, 6 months, 12 months
Title
Change in Alcohol Use Behavior
Description
Change in Substance use frequency (i.e., number of times per day) for alcohol of participants as measured by the Daily Drinking Questionnaire
Time Frame
Baseline, 1 month, 3 months, 6 months, 12 months
Title
Change in Substance Use Behavior
Description
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
Time Frame
Baseline, 1 month, 3 months, 6 months, 12 months
Title
Change in Participant Ratings of Unhealthy Food Palatability
Description
Change in Participant behavioral response to food pictures, and subjective palatability rating
Time Frame
Baseline, 1 month
Title
Change in Participant Ratings of Food Monetary Value
Description
Change in Participant behavioral response to food pictures, and willingness to pay given dollar amounts (aggregate score) for the pictured food
Time Frame
Baseline, 1 month
Title
Change in Food Craving and Liking Behavior
Description
Change Participant food craving behaviors as measured by the Food Craving and Liking Scale
Time Frame
Baseline, 1 month, 3 months, 6 months, 12 months
Title
Change in Body Mass Index
Description
Change in Participant BMI using standard methods of calculation
Time Frame
Baseline, 1 month, 3 months, 6 months, 12 months
Title
Change in mean R-Peak Amplitude
Description
Change in mean R-Peak Amplitude measured using three-lead ECG using PowerLab 8 Diagnostic Suite
Time Frame
Baseline, 1 month, 3 months, 6 months, 12 months
Title
Change in Heart Rate Variability
Description
Change in Heart Rate Variability measured using three-lead ECG using PowerLab 8 Diagnostic Suite
Time Frame
Baseline, 1 month, 3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body Mass Index Between 25 and 35 Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Stice, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33851199
Citation
Yokum S, Bohon C, Berkman E, Stice E. Test-retest reliability of functional MRI food receipt, anticipated receipt, and picture tasks. Am J Clin Nutr. 2021 Aug 2;114(2):764-779. doi: 10.1093/ajcn/nqab096.
Results Reference
derived

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Computerized Response Training Obesity Treatment

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