Computerized Response Training Obesity Treatment

Obesity Clinical Trial

— CC  

Official title:

Translational Neuroscience: Response Training for Obesity Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03375853
• Other study ID #: DK112762
• Status: Completed
• Phase: N/A
• Start date: July 15, 2017
• Est. completion date: September 15, 2023

Study information

• Verified date: September 2023
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: September 15, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 38 Years

Eligibility

Inclusion Criteria:

• Body Mass Index Between 25 and 35 Exclusion Criteria:

Related Conditions & MeSH terms

• Feeding and Eating Disorders
• Hyperphagia
• Obesity

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.
• 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.

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon

Sponsors (5)

Lead Sponsor	Collaborator
Oregon Research Institute	Flinders University, Radboud University Medical Center, University of Exeter, University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Fat Change	Change in participant's body fat percentage	Baseline, 1 month, 3 months, 6 months, 12 months
Secondary	Change in Eating Disorder Symptoms	Eating disorder symptoms as measured with the Eating Disorder Diagnostic Interview	Baseline, 1 month, 3 months, 6 months, 12 months
Secondary	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	Baseline, 1 month, 3 months, 6 months, 12 months
Secondary	Change in Disinhibited Eating Behavior	Chang in Disinhibited Eating as measured by the Three Factor Eating Questionnaire	Baseline, 1 month, 3 months, 6 months, 12 months
Secondary	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	Baseline, 1 month, 3 months, 6 months, 12 months
Secondary	Change in Food Addiction Behavior	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
Secondary	Change in Physical Activity	Change in Physical Activity as measured by the Paffenberger Questionnaire	Baseline, 1 month, 3 months, 6 months, 12 months
Secondary	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	Baseline, 1 month, 3 months, 6 months, 12 months
Secondary	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	Baseline, 1 month, 3 months, 6 months, 12 months
Secondary	Change in Participant Ratings of Unhealthy Food Palatability	Change in Participant behavioral response to food pictures, and subjective palatability rating	Baseline, 1 month
Secondary	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	Baseline, 1 month
Secondary	Change in Food Craving and Liking Behavior	Change Participant food craving behaviors as measured by the Food Craving and Liking Scale	Baseline, 1 month, 3 months, 6 months, 12 months
Secondary	Change in Body Mass Index	Change in Participant BMI using standard methods of calculation	Baseline, 1 month, 3 months, 6 months, 12 months
Secondary	Change in mean R-Peak Amplitude	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
Secondary	Change in Heart Rate Variability	Change in Heart Rate Variability measured using three-lead ECG using PowerLab 8 Diagnostic Suite	Baseline, 1 month, 3 months, 6 months, 12 months