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Computerized Response Training Obesity Treatment (CC)

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ClinicalTrials.gov Identifier: NCT03375853
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Collaborators:
Flinders University
University of Exeter
Radboud University
University of Oregon
Information provided by (Responsible Party):
Oregon Research Institute

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.

Condition or disease Intervention/treatment Phase
Obesity Hyperphagia Feeding and Eating Disorders Behavioral: Computer Based Response Training Weight Loss Intervention Behavioral: Generic Response Training Control Intervention Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Translational Neuroscience: Response Training for Obesity Treatment
Actual Study Start Date : July 15, 2017
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

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.
Behavioral: 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 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 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.
Behavioral: Computer Based Response Training Weight Loss 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.




Primary Outcome Measures :
  1. Body Fat Change [ Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months ]
    Change in participant's body fat percentage


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body Mass Index Between 25 and 35

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375853


Contacts
Contact: Sonja Yokum, PhD (541) 484-2123 ext 2121 sonjas@ori.org
Contact: Zachary M Cunningham, BS (541) 484-2123 ext 2984 zcunningham@ori.org

Locations
United States, Oregon
Oregon Research Institute Recruiting
Eugene, Oregon, United States, 97403
Contact: Sonja Yokum, PhD    541-484-2123 ext 2121    sonjas@ori.org   
Contact: Zachary M Cunningham, BS    (541) 484-2123 ext 2984    zcunningham@ori.org   
Principal Investigator: Eric Stice, PhD         
Sub-Investigator: Sonja Yokum, PhD         
Sponsors and Collaborators
Oregon Research Institute
Flinders University
University of Exeter
Radboud University
University of Oregon
Investigators
Principal Investigator: Eric Stice, PhD Oregon Research Institute

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT03375853     History of Changes
Other Study ID Numbers: DK112762
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Oregon Research Institute:
Obesity
Dissonance
Response Training
Eating Disorder
Computer-based Training

Additional relevant MeSH terms:
Obesity
Feeding and Eating Disorders
Hyperphagia
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Mental Disorders
Signs and Symptoms, Digestive