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ObesityCCNCT03375853

Computerized Response Training Obesity Treatment

A study testing Computer Based Response Training Weight Loss Intervention in people with Obesity and Hyperphagia, run by Oregon Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 38 years
Conditions the study is for
Obesity, Hyperphagia, Feeding and Eating Disorders
What is being tested?
Computer Based Response Training Weight Loss Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
179 participants
Where
1 siteUnited States
Study dates
15 Jul 2017to 15 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 38 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Body Mass Index Between 25 and 35

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Oregon Research Institute

    Eugene, Oregon, 97403

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Computer Based Response Training Weight Loss Intervention, Generic Response Training Control Intervention
Keywords
Obesity, Dissonance, Response Training, Eating Disorder, Computer-based Training
Medical subject headings
Obesity, Hyperphagia, Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computer Based Response Training Weight Loss InterventionBehavioural

    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 InterventionBehavioural

    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.

Study groups in NCT03375853
Study groupRoleWhat they receive
Control ConditionActive comparatorParticipants 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.
Receives: Behavioral: Generic Response Training Control Intervention
Experimental ConditionExperimentalParticipants 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.
Receives: Behavioral: Computer Based Response Training Weight Loss Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Fat Change

    Change in participant's body fat percentage

    Measured: Baseline, 1 month, 3 months, 6 months, 12 months

Secondary outcomes (14)
  1. Change in Eating Disorder Symptoms

    Eating disorder symptoms as measured with the Eating Disorder Diagnostic Interview

    Measured: Baseline, 1 month, 3 months, 6 months, 12 months

  2. 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

    Measured: Baseline, 1 month, 3 months, 6 months, 12 months

  3. Change in Disinhibited Eating Behavior

    Chang in Disinhibited Eating as measured by the Three Factor Eating Questionnaire

    Measured: Baseline, 1 month, 3 months, 6 months, 12 months

  4. 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

    Measured: Baseline, 1 month, 3 months, 6 months, 12 months

  5. Change in Food Addiction Behavior

    Change in Problematic eating patterns associated with symptoms of addictive behaviors as measured by the Yale Food Addiction Scale

    Measured: Baseline, 1 month, 3 months, 6 months, 12 months

  6. Change in Physical Activity

    Change in Physical Activity as measured by the Paffenberger Questionnaire

    Measured: Baseline, 1 month, 3 months, 6 months, 12 months

  7. 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

    Measured: Baseline, 1 month, 3 months, 6 months, 12 months

  8. 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

    Measured: Baseline, 1 month, 3 months, 6 months, 12 months

  9. Change in Participant Ratings of Unhealthy Food Palatability

    Change in Participant behavioral response to food pictures, and subjective palatability rating

    Measured: Baseline, 1 month

  10. 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

    Measured: Baseline, 1 month

  11. Change in Food Craving and Liking Behavior

    Change Participant food craving behaviors as measured by the Food Craving and Liking Scale

    Measured: Baseline, 1 month, 3 months, 6 months, 12 months

  12. Change in Body Mass Index

    Change in Participant BMI using standard methods of calculation

    Measured: Baseline, 1 month, 3 months, 6 months, 12 months

  13. Change in mean R-Peak Amplitude

    Change in mean R-Peak Amplitude measured using three-lead ECG using PowerLab 8 Diagnostic Suite

    Measured: Baseline, 1 month, 3 months, 6 months, 12 months

  14. Change in Heart Rate Variability

    Change in Heart Rate Variability measured using three-lead ECG using PowerLab 8 Diagnostic Suite

    Measured: Baseline, 1 month, 3 months, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2017
  2. Study start15 Jul 2017
  3. Primary completion31 Aug 2023
  4. Study completion15 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03375853
Sponsor's protocol ID
DK112762
Acronym
CC
Status last verified
Sep 2023
First submitted
17 May 2017
Last updated
26 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33851199

Questions about this trial

What is this clinical trial studying?

A study testing Computer Based Response Training Weight Loss Intervention in people with Obesity and Hyperphagia, run by Oregon Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Fat Change (time frame: Baseline, 1 month, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03375853, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.

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