Clinical trial NCT03557710: Devaluing Foods to Change Eating Behavior
Official title: Devaluing Energy-dense Foods for Cancer-control: Translational Neuroscience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Cancer
Keywords: eating
overweight
obesity
cancer risk
translational neuroscience
cognitive reappraisal
functional magnetic resonance imaging (fMRI)
vmPFC
inhibitory control
valuation
Lead sponsor: University of Oregon
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Quantify the degree to which cognitive and behavioral interventions alter the valuation of cancer-risk foods relative to an active control. We will recruit 300 overweight/obese adults who are at risk for eating- and obesity-related cancers and randomize them to a (a) behavioral response training toward low cancer-risk foods and away from high cancer-risk foods, (b) cognitive reappraisal intervention focused on cancer-risk foods (experimental arms), or (c) non-food inhibitory control training (active control arm). Valuation, our primary mediating process as implicated in the incentive sensitization model, will be measured using behavioral economics tasks and functional magnetic resonance imaging (fMRI) of the vmPFC at pre- and posttraining. Proximal, intervention-specific mediators will also be indexed with fMRI. A final analysis will compare the potency of the intervention-specific neural systems to alter valuation via connectivity to vmPFC.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Food Intake at 1 month using dietary assessment tool
timeFrame: baseline, 1 month
measure: Change from Baseline Food Intake at 1 month, Self-Report Questionnaire
timeFrame: baseline, 1 month
Secondary outcomes:
measure: Change from Baseline Body Fat Percent at 1 month
timeFrame: baseline, 1 month
measure: Change from Baseline Body Mass Index at 1 month
timeFrame: baseline, 1 month
measure: Change from Baseline Waist-to-Hip Ratio at 1 month
timeFrame: baseline, 1 month
measure: Change from Baseline Food Approach and Avoidance Behavior at 1 month, Self-Report Questionnaire 2
timeFrame: baseline, 1 month
measure: Change from Baseline Food Approach and Avoidance Behavior at 1 month, Self-Report Questionnaire 3
timeFrame: baseline, 1 month
measure: Change from Baseline Cognitive Tendencies at 1 month, Self-Report Questionnaire 1
timeFrame: baseline, 1 month
measure: Change from Baseline Cognitive Tendencies at 1 month, Self-Report Questionnaire 2
timeFrame: baseline, 1 month
measure: Change from Baseline Food-related Habitual Behavior at 1 month, Self-report Questionnaire 1
timeFrame: baseline, 1 month
measure: Change from Baseline Cancer Risk and Healthy Food Craving and Valuation at 1 month, Self-report Questionnaire 2
timeFrame: baseline, 1 month
measure: Change from Baseline Behavioral Response Biases Toward and Away from Cancer Risk and Healthy Foods at 1 month, Behavioral marker, Task 1
timeFrame: baseline, 1 month
measure: Change from Baseline Behavioral Response Biases Toward and Away from Cancer Risk and Healthy Foods at 1 month, Behavioral marker, Task 2
timeFrame: baseline, 1 month
measure: Change from Baseline Cognitive Reappraisal of Food at 1 month, Behavioral marker
timeFrame: baseline, 1 month
measure: Change from Baseline Valuation of Subjective Value of Various Foods at 1 month, Behavioral marker
timeFrame: baseline, 1 month
measure: Change from Baseline Habitual Response to Food at 1 month, Behavioral marker
timeFrame: baseline, 1 month
measure: Change from Baseline Behavioral Response Biases Toward and Away from Cancer Risk and Healthy Foods at 1 month, Neural marker, Task 1
timeFrame: baseline, 1 month
measure: Change from Baseline Behavioral Response Biases Toward and Away from Cancer Risk and Healthy Foods at 1 month, Neural marker, Task 2
timeFrame: baseline, 1 month
measure: Change from Baseline Cognitive Reappraisal of Food at 1 month, Neural marker
timeFrame: baseline, 1 month
measure: Change from Baseline Habitual Response to Food at 1 month, Neural marker
timeFrame: baseline, 1 month
measure: Change from Baseline Valuation of Subjective Value of Various Foods at 1 month, Neural marker
timeFrame: baseline, 1 month
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon, Lewis Integrative Sciences Building
state: Oregon
Study officials:
affiliation: University of Oregon
name: Elliot Berkman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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