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Completed

NCT Number: NCT03375853

Computerized Response Training 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.

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Key information

Age range

18 year–38 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Research Institute

Eugene, Oregon, 97403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index Between 25 and 35

Exclusion criteria

Treatment and study plan

Computer Based Response Training Weight Loss Intervention

Behavioral

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.

Generic Response Training Control Intervention

Behavioral

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 outcomes

  1. Body Fat Change

    Time frame: Baseline, 1 month, 3 months, 6 months, 12 months

    Change in participant's body fat percentage

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Oregon Research Institute

Other

Collaborators

  • Flinders University
  • Radboud University Medical Center
  • University of Exeter
  • University of Oregon

Registry information

Official study title

Translational Neuroscience: Response Training for Obesity Treatment

Acronym: CC

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Dec 18, 2017
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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