Devaluing Foods to Change Eating Behavior

August 9, 2023 updated by: University of Oregon

Devaluing Energy-dense Foods for Cancer-control: Translational Neuroscience

Excessive eating of energy-dense foods and obesity are risk factors for a range of cancers. There are programs to reduce intake of these foods and weight loss, but the effects of the programs rarely last. This project tests whether altering the value of cancer-risk foods can create lasting change, and uses neuroimaging to compare the efficacy of two programs to engage the valuation system on a neural level. Results will establish the pathways through which the programs work and suggest specific treatments for individuals based on a personalized profile.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Obesity and intake of certain foods increase cancer risk, but the most common treatment (behavioral weight loss programs) rarely produces lasting weight loss and eating behavior change, apparently because caloric restriction increases the reward value of food and prompts energy-sparing adaptations. Interventions that reduce the implicit valuation of cancer-risk foods (e.g., red meats, refined sugar) may be more effective. Emerging data suggest that behavioral response training and cognitive reappraisal training reduce valuation of such foods, which leads to decrease intake of these foods and weight loss. Internalized incentive value is reflected in a ventromedial prefrontal cortex (vmPFC) / orbitofrontal cortex valuation system, which encodes the implicit reward value of food and is central to a reinforcement cycle that perpetuates unhealthy eating. Thus, the vmPFC valuation system is a promising target for intervention because changes to the system might disrupt the unhealthy reinforcement cycle. Interestingly, various interventions influence the vmPFC through distinct pathways. Behavioral training alters motor input to valuation regions, whereas cognitive training relies on lateral prefrontal "top-down" regions. The proposed translational neuroscience experiment will compare the efficacy with which two novel treatments cause lasting change in food valuation, and whether a composite of theory-based baseline individual differences in relevant processes (such as response tendencies and cognitive styles) moderate treatment effects. We will randomize 300 overweight/obese adults who are at risk for eating- and obesity-related cancers to behavioral response training toward healthy foods and away from cancer-risk foods, a cognitive reappraisal intervention focused on cancer-risk foods, or non-food inhibitory control training. Aim 1 compares the efficacy and mechanisms of action of these two interventions to reduce valuation of cancer-risk foods relative to the active control condition, using neural, behavioral, self-report, and physiological measures of the process and outcomes. Aim 2 is to establish the temporal pattern and durability of the effects across time; food intake and habits, body fat, BMI, and waist-to-hip ratio will be measured pre, post, and at 3-, 6-, and 12-month follow-up. Aim 3 uses machine learning to build and validate a low-cost, easy-to-administer composite that predicts whether and for how long an individual is likely to respond to intervention, and to which treatment. We hypothesize that self-report measures specifically related to valuation (e.g., willingness-to-pay) and to intervention-specific pathways to valuation (e.g., behavioral response tendencies, cognitive style) will predict differential response. Discovering these individual differences will provide a practical, low-cost tool to help interventionists "match" a given person to an effective treatment for that person. This project is very innovative because no study has directly compared the distinct and common effects of these treatments on valuation, used brain imaging to study the mechanism of effects, tested whether these interventions produce a lasting change in food valuation and body fat, or built and validated a composite that moderates response.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
253

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Oregon
      • Eugene, Oregon, United States, 97403
        • University of Oregon, Lewis Integrative Sciences Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- overweight to obese range (BMI 25-35)

Exclusion Criteria:

  • metal implants (e.g., braces, permanent retainers, pins)
  • metal fragments, pacemakers or other electronic medical implants
  • claustrophobia
  • weight ˃ 550 lbs.
  • Women who are pregnant or believe they might be pregnant
  • people who have been diagnosed with past or current medical, psychiatric, neurological, eating disorders, or are taking psychotropic medications
  • urine screen to exclude participants who are acutely intoxicated
  • screen for handedness

Beyond these criteria, participants will be recruited without exclusions based on gender, race, or ethnicity, so our sample will reflect the diversity in the local population (Lane County, Oregon) with regard to gender, race, and ethnicity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Behavioral Response Training
In Arm 1 of Devaluing energy-dense foods for cancer-control, participants will complete computer delivered versions of the stop-signal, go/no-go, and dot-probe training tasks in 8 30-min biweekly visits to the lab, with breaks between training blocks in which participants sit with their eyes closed to allow consolidation of learning. Participants will also complete a weekly 15-min training task online from home. Total training time = 345 min. Training will involve 100 images of cancer risk foods that participants regularly eat, including red and processed meats; high-sugar foods; heavily salted, smoked, and pickled foods; fries, chips, and snacks with trans-fats, and 100 images of healthy foods that participants rate as palatable, including vegetables, fruits, nuts, and whole grains.
Behavioral: Devaluing energy-dense foods for cancer-control
A 3-arm randomized controlled trial experiment study over 12 months. At baseline, participants will complete behavioral, neural, and self-report measures related to food, specifically measures of food valuation and of the proximal neural systems hypothesized to be linked to each of the 2 experimental arms. We will also measure food intake and body composition at baseline. Then participants will be randomized to one of 3 arms (2 experimental + 1 active control) for 8 30-min sessions to occur twice weekly at the University of Oregon for 30 days. At endpoint (~1 month following baseline), all behavioral, neural, and self-report measures will be reassessed, as will eating, habit, and body composition measures. Follow-ups at 3, 6, and 12 months will assess all measures except neuroimaging.
Other Names:
  • Devaluing foods to change eating behavior
Experimental: Cognitive Reappraisal Training
Arm 2 of the Devaluing energy-dense foods for cancer-control intervention will be delivered via computer-assisted in-person training. Between baseline and endpoint sessions, participants will practice reappraisal on a computer, under close supervision of a facilitator, in 8 30-min twice-weekly individual sessions. During sessions, participants will practice cognitive reappraisal to reduce the value of cancer risk foods. Participants will also practice reappraisal of cancer risk foods on a computer at home, twice weekly for 15 minutes, for a total intervention time of contact of 345 minutes. The facilitator will review homework completed by participants and offer corrective feedback. The home practice is intended to promote generalization of use of this skill in the natural environment.
Behavioral: Devaluing energy-dense foods for cancer-control
A 3-arm randomized controlled trial experiment study over 12 months. At baseline, participants will complete behavioral, neural, and self-report measures related to food, specifically measures of food valuation and of the proximal neural systems hypothesized to be linked to each of the 2 experimental arms. We will also measure food intake and body composition at baseline. Then participants will be randomized to one of 3 arms (2 experimental + 1 active control) for 8 30-min sessions to occur twice weekly at the University of Oregon for 30 days. At endpoint (~1 month following baseline), all behavioral, neural, and self-report measures will be reassessed, as will eating, habit, and body composition measures. Follow-ups at 3, 6, and 12 months will assess all measures except neuroimaging.
Other Names:
  • Devaluing foods to change eating behavior
Active Comparator: Generic Response Training
In Arm 3 (active control) of the Devaluing energy-dense foods for cancer-control intervention will be identical in duration and contact time to the behavioral response training described above (345 min total), but will involve nonfood images (birds and flowers), as described in the pilot trial. Participants will be informed that this intervention is designed to improve response inhibition, which should lead to eating change and weight loss given that impulsivity increases the risk for overeating, ensuring the credibility of the control arm.
Behavioral: Devaluing energy-dense foods for cancer-control
A 3-arm randomized controlled trial experiment study over 12 months. At baseline, participants will complete behavioral, neural, and self-report measures related to food, specifically measures of food valuation and of the proximal neural systems hypothesized to be linked to each of the 2 experimental arms. We will also measure food intake and body composition at baseline. Then participants will be randomized to one of 3 arms (2 experimental + 1 active control) for 8 30-min sessions to occur twice weekly at the University of Oregon for 30 days. At endpoint (~1 month following baseline), all behavioral, neural, and self-report measures will be reassessed, as will eating, habit, and body composition measures. Follow-ups at 3, 6, and 12 months will assess all measures except neuroimaging.
Other Names:
  • Devaluing foods to change eating behavior

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Food Intake at 1 month using dietary assessment tool
Time Frame: baseline, 1 month
Assessed with the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool The National Cancer Institutes's standard self-assessment instrument to comprehensively measure food intake.
baseline, 1 month
Change from Baseline Food Intake at 1 month, Self-Report Questionnaire
Time Frame: baseline, 1 month
Food-Frequency Questionnaire modified to include cancer risk foods
baseline, 1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Body Fat Percent at 1 month
Time Frame: baseline, 1 month
Assessed with a BodPod (body pod) air displacement system
baseline, 1 month
Change from Baseline Body Mass Index at 1 month
Time Frame: baseline, 1 month
Index of body composition based on height and weight
baseline, 1 month
Change from Baseline Waist-to-Hip Ratio at 1 month
Time Frame: baseline, 1 month
Index of body morphology based on external measurements
baseline, 1 month
Change from Baseline Food Approach and Avoidance Behavior at 1 month, Self-Report Questionnaire 2
Time Frame: baseline, 1 month
Barratt Impulsivity self-report questionnaire, measuring the construct of impulsivity. There are three subscales: Attentional impulsivity (8 items), motor impulsivity (10 items) non-planning impulsivity (12 items). Participants respond to each item on a 1-to-4 Likert scale and scores are averaged within subscales (yielding three 1-to-4 average scores) then averaged across the three subscales to yield one 1-to-4 overall score. Higher scores indicate higher impulsivity, which is a worse outcome.
baseline, 1 month
Change from Baseline Food Approach and Avoidance Behavior at 1 month, Self-Report Questionnaire 3
Time Frame: baseline, 1 month
Restraint Scale self-report questionnaire. This questionnaire measures the construct of dietary restraint. There are 2 subscales: concern for dieting and weight fluctuations. Participants answer 6 questions about concern for dieting (1-to-5) that are averaged to create a 1-to-5 score on dieting concern. Dieting concern is expected to be u-shaped in terms of better or worse, where no concern or extreme concern is worse and moderate concern is better. Participants answer 4 questions about weight fluctuations (1-to-5) that are averaged to create a 1-to-5 score for weight fluctuation. Great fluctuation is a worse outcome.
baseline, 1 month
Change from Baseline Cognitive Tendencies at 1 month, Self-Report Questionnaire 1
Time Frame: baseline, 1 month
Need for Cognition self-report questionnaire, which measures the construct of cognitive engagement and enjoyment of thinking. Participants complete 18 items on a 9-point Likert scale (-4 to +4) and scores are averaged across all items to create a single score that ranges from -4 to +4. Higher scores indicate a better outcome, indicating more enjoyment of thinking processes.
baseline, 1 month
Change from Baseline Cognitive Tendencies at 1 month, Self-Report Questionnaire 2
Time Frame: baseline, 1 month
Craving Regulation Scale self-report questionnaire, which measures the construct of self-regulation of food cravings. There are 24 items total, with 4 items within each of 6 subscales: avoidance of temptation, controlling temptations, distraction, suppression, goal/rule setting, and goal deliberation. Responses are on a 1-to-5 Likert scale and averaged within subscales to create 6 1-to-5 average ratings. Those six averages are also averaged to create an overall score. Greater scores indicate better self-regulation of craving, which is a desired outcome.
baseline, 1 month
Change from Baseline Food-related Habitual Behavior at 1 month, Self-report Questionnaire 1
Time Frame: baseline, 1 month
Food version of the Self-Report Habit Index self-report questionnaire. This measures the construct of habitual eating of healthy and unhealthy foods. The scale contains two subscales: healthy foods and unhealthy foods. Each subscale contains 12 items, and responses are on a 1-to-5 Likert scale. Responses are averaged within each subscale to create 1-to-5 average ratings for habitual eating of healthy and unhealthy foods, respectively. The subscales are reported separately and not combined. Greater numbers indicate more habitual eating, so lower averages on the unhealthy subscale and higher averages on the healthy subscale indicate a better outcome.
baseline, 1 month
Change from Baseline Cancer Risk and Healthy Food Craving and Valuation at 1 month, Self-report Questionnaire 2
Time Frame: baseline, 1 month
Food Craving Inventory self-report questionnaire measuring craving and valuation in dollars per serving of cancer risk and healthy foods. There are 28 items on each subscale (one for craving and one for valuation), and the items are averaged within each subscale. The range of the craving scale is 1-5 (i.e., average of 28 1-to-5 Likert ratings) and the range of the valuation scale is 1-4 (i.e., average of 28 1-to-4 Likert ratings). The subscales are reported separately and not combined. Greater numbers indicate more craving / value of the unhealthy foods, so lower numbers indicate a better outcome.
baseline, 1 month
Change from Baseline Behavioral Response Biases Toward and Away from Cancer Risk and Healthy Foods at 1 month, Behavioral marker, Task 1
Time Frame: baseline, 1 month
Performance on a standard inhibitory control task (Stop-Signal) with personal risk cues
baseline, 1 month
Change from Baseline Behavioral Response Biases Toward and Away from Cancer Risk and Healthy Foods at 1 month, Behavioral marker, Task 2
Time Frame: baseline, 1 month
Performance on a standard inhibitory control task (Go/No-Go) with personal risk cues
baseline, 1 month
Change from Baseline Cognitive Reappraisal of Food at 1 month, Behavioral marker
Time Frame: baseline, 1 month
Performance on a Regulation of Craving Task for Food
baseline, 1 month
Change from Baseline Valuation of Subjective Value of Various Foods at 1 month, Behavioral marker
Time Frame: baseline, 1 month
Performance on Willingness-to-Pay Task - Food
baseline, 1 month
Change from Baseline Habitual Response to Food at 1 month, Behavioral marker
Time Frame: baseline, 1 month
Performance on Speeded Cue-Behavior Association Task
baseline, 1 month
Change from Baseline Behavioral Response Biases Toward and Away from Cancer Risk and Healthy Foods at 1 month, Neural marker, Task 1
Time Frame: baseline, 1 month
Premotor, basal ganglia, dorsal cingulate, and Thalamus Activity during standard inhibitory control task (Stop-Signal) with personal risk cues
baseline, 1 month
Change from Baseline Behavioral Response Biases Toward and Away from Cancer Risk and Healthy Foods at 1 month, Neural marker, Task 2
Time Frame: baseline, 1 month
Premotor, basal ganglia, dorsal cingulate, and Thalamus Activity during standard inhibitory control task (Go/No-Go) with personal risk cues
baseline, 1 month
Change from Baseline Cognitive Reappraisal of Food at 1 month, Neural marker
Time Frame: baseline, 1 month
Dorsolateral Prefrontal Cortex and ventrolateral Prefrontal Cortex activity during Regulation of Craving Task for Food
baseline, 1 month
Change from Baseline Habitual Response to Food at 1 month, Neural marker
Time Frame: baseline, 1 month
Shift from ventral to dorsal striatum activity during Speeded Cue-Behavior Association Task
baseline, 1 month
Change from Baseline Valuation of Subjective Value of Various Foods at 1 month, Neural marker
Time Frame: baseline, 1 month
Ventromedial prefrontal cortex activity during the Willingness-to-Pay Task - Food
baseline, 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oregon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elliot Berkman, Ph.D., University of Oregon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EPCS24327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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