Study Summary
This trial is testing whether two different programs can help people reduce their intake of energy-dense foods and lose weight, with the goal of reducing their risk of cancer.
Eligible Conditions
- Cancer
- Overweight and Obesity
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
2 Primary · 19 Secondary · Reporting Duration: baseline, 1 month
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
Change from Baseline Behavioral Response Biases Toward and Away from Cancer Risk and Healthy Foods at 1 month, Behavioral marker, Task 2
Change from Baseline Behavioral Response Biases Toward and Away from Cancer Risk and Healthy Foods at 1 month, Neural marker, Task 1
Change from Baseline Behavioral Response Biases Toward and Away from Cancer Risk and Healthy Foods at 1 month, Neural marker, Task 2
Change from Baseline Body Fat Percent at 1 month
Change from Baseline Body Mass Index at 1 month
Change from Baseline Cancer Risk and Healthy Food Craving and Valuation at 1 month, Self-report Questionnaire 2
Change from Baseline Cognitive Reappraisal of Food at 1 month, Behavioral marker
Change from Baseline Cognitive Reappraisal of Food at 1 month, Neural marker
Change from Baseline Cognitive Tendencies at 1 month, Self-Report Questionnaire 1
Change from Baseline Cognitive Tendencies at 1 month, Self-Report Questionnaire 2
Change from Baseline Food Approach and Avoidance Behavior at 1 month, Self-Report Questionnaire 2
Change from Baseline Food Approach and Avoidance Behavior at 1 month, Self-Report Questionnaire 3
Change from Baseline Food Intake at 1 month using dietary assessment tool
Change from Baseline Food Intake at 1 month, Self-Report Questionnaire
Change from Baseline Food-related Habitual Behavior at 1 month, Self-report Questionnaire 1
Change from Baseline Habitual Response to Food at 1 month, Behavioral marker
Change from Baseline Habitual Response to Food at 1 month, Neural marker
Change from Baseline Valuation of Subjective Value of Various Foods at 1 month, Behavioral marker
Change from Baseline Valuation of Subjective Value of Various Foods at 1 month, Neural marker
Hip structure
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
3 Treatment Groups
Generic Response Training
1 of 3
Behavioral Response Training
1 of 3
Cognitive Reappraisal Training
1 of 3
Active Control
Experimental Treatment
253 Total Participants · 3 Treatment Groups
Primary Treatment: Devaluing energy-dense foods for cancer-control · No Placebo Group · N/A
Behavioral Response Training
Behavioral
Experimental Group · 1 Intervention: Devaluing energy-dense foods for cancer-control · Intervention Types: BehavioralCognitive Reappraisal Training
Behavioral
Experimental Group · 1 Intervention: Devaluing energy-dense foods for cancer-control · Intervention Types: BehavioralGeneric Response Training
Behavioral
ActiveComparator Group · 1 Intervention: Devaluing energy-dense foods for cancer-control · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 month
Who is running the clinical trial?
University of OregonLead Sponsor
71 Previous Clinical Trials
39,143 Total Patients Enrolled
Elliot Berkman, Ph.D.Principal InvestigatorUniversity of Oregon
Eligibility Criteria
Age 18 - 60 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Stice, Eric, Paul Rohde, Jeff Gau, and Heather Shaw. 2009. “An Effectiveness Trial of a Dissonance-based Eating Disorder Prevention Program for High-risk Adolescent Girls.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/a0016132.
- Stice, Eric, Sonja Yokum, Kyle Burger, Paul Rohde, Heather Shaw, and Jeff M. Gau. 2015. “A Pilot Randomized Trial of a Cognitive Reappraisal Obesity Prevention Program”. Physiology & Behavior. Elsevier BV. doi:10.1016/j.physbeh.2014.10.022.
- Giuliani, Nicole R., Traci Mann, A. Janet Tomiyama, and Elliot T. Berkman. 2014. “Neural Systems Underlying the Reappraisal of Personally Craved Foods”. Journal of Cognitive Neuroscience. MIT Press - Journals. doi:10.1162/jocn_a_00563.
- Stice, Eric, Sonja Yokum, Harm Veling, Eva Kemps, and Natalia S. Lawrence. 2017. “Pilot Test of a Novel Food Response and Attention Training Treatment for Obesity: Brain Imaging Data Suggest Actions Shape Valuation”. Behaviour Research and Therapy. Elsevier BV. doi:10.1016/j.brat.2017.04.007.
- Stice, Eric, C. Nathan Marti, Sonja Spoor, Katherine Presnell, and Heather Shaw. 2008. “Dissonance and Healthy Weight Eating Disorder Prevention Programs: Long-term Effects from a Randomized Efficacy Trial.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/0022-006x.76.2.329.
- Berkman, Elliot T., and Emily B. Falk. 2013. “Beyond Brain Mapping”. Current Directions in Psychological Science. SAGE Publications. doi:10.1177/0963721412469394.
- Giuliani, Nicole R., Rebecca D. Calcott, and Elliot T. Berkman. 2013. “Piece of Cake. Cognitive Reappraisal of Food Craving”. Appetite. Elsevier BV. doi:10.1016/j.appet.2012.12.020.
- Stice, Eric, Paul Rohde, Heather Shaw, and Jeff Gau. 2011. “An Effectiveness Trial of a Selected Dissonance-based Eating Disorder Prevention Program for Female High School Students: Long-term Effects.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/a0024351.
- Berkman, Elliot T., Emily B. Falk, and Matthew D. Lieberman. 2011. “In the Trenches of Real-world Self-control”. Psychological Science. SAGE Publications. doi:10.1177/0956797611400918.
- Stice, Eric, Kyle Burger, and Sonja Yokum. 2013. “Caloric Deprivation Increases Responsivity of Attention and Reward Brain Regions to Intake, Anticipated Intake, and Images of Palatable Foods”. Neuroimage. Elsevier BV. doi:10.1016/j.neuroimage.2012.11.028.
- Berkman, E. T., L. E. Kahn, and J. S. Merchant. 2013. “Training-induced Changes in Inhibitory Control Network Activity”. Journal of Neuroscience. Society for Neuroscience. doi:10.1523/jneurosci.3564-13.2014.
- Stice, Eric, Katherine Presnell, Jeff Gau, and Heather Shaw. 2007. “Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Two Eating Disorder Prevention Programs.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/0022-006x.75.1.20.
- Stice, Eric, Paul Rohde, Shelley Durant, and Heather Shaw. 2012. “A Preliminary Trial of a Prototype Internet Dissonance-based Eating Disorder Prevention Program for Young Women with Body Image Concerns.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/a0028016.
- Giuliani, Nicole R., A. Janet Tomiyama, Traci Mann, and Elliot T. Berkman. 2015. “Prediction of Daily Food Intake as a Function of Measurement Modality and Restriction Status”. Psychosomatic Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/psy.0000000000000187.
- Stice, Eric, Natalia S. Lawrence, Eva Kemps, and Harm Veling. 2016. “Training Motor Responses to Food: A Novel Treatment for Obesity Targeting Implicit Processes”. Clinical Psychology Review. Elsevier BV. doi:10.1016/j.cpr.2016.06.005.
- Berkman, Elliot T., Lisa Burklund, and Matthew D. Lieberman. 2009. “Inhibitory Spillover: Intentional Motor Inhibition Produces Incidental Limbic Inhibition via Right Inferior Frontal Cortex”. Neuroimage. Elsevier BV. doi:10.1016/j.neuroimage.2009.04.084.
- Fisher, Philip A., and Elliot T. Berkman. 2015. “Designing Interventions Informed by Scientific Knowledge About Effects of Early Adversity: A Translational Neuroscience Agenda for Next-generation Addictions Research”. Current Addiction Reports. Springer Science and Business Media LLC. doi:10.1007/s40429-015-0071-x.
- Stice, Eric, Kyle Burger, and Sonja Yokum. 2013. “Caloric Deprivation Increases Responsivity of Attention and Reward Brain Regions to Intake, Anticipated Intake, and Images of Palatable Foods”. Neuroimage. Elsevier BV. doi:10.1016/j.neuroimage.2012.11.028.
- Stice E, Rohde P, Durant S, Shaw H. A preliminary trial of a prototype Internet dissonance-based eating disorder prevention program for young women with body image concerns. J Consult Clin Psychol. 2012 Oct;80(5):907-16. doi: 10.1037/a0028016. Epub 2012 Apr 16.
- Berkman ET, Falk EB. Beyond Brain Mapping: Using Neural Measures to Predict Real-World Outcomes. Curr Dir Psychol Sci. 2013 Feb;22(1):45-50. doi: 10.1177/0963721412469394.
- Fisher PA, Berkman ET. Designing Interventions Informed by Scientific Knowledge About Effects of Early Adversity: A Translational Neuroscience Agenda for Next Generation Addictions Research. Curr Addict Rep. 2015 Dec 1;2(4):347-353. doi: 10.1007/s40429-015-0071-x. Epub 2015 Sep 28.
- Stice E, Presnell K, Gau J, Shaw H. Testing mediators of intervention effects in randomized controlled trials: An evaluation of two eating disorder prevention programs. J Consult Clin Psychol. 2007 Feb;75(1):20-32. doi: 10.1037/0022-006X.75.1.20.
- Stice E, Lawrence NS, Kemps E, Veling H. Training motor responses to food: A novel treatment for obesity targeting implicit processes. Clin Psychol Rev. 2016 Nov;49:16-27. doi: 10.1016/j.cpr.2016.06.005. Epub 2016 Jul 21.
- 2018. "Devaluing Foods to Change Eating Behavior". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03557710.
Frequently Asked Questions
What are the main goals of this clinical investigation?
"This clinical trial seeks to assess changes in food intake, behavioral responses towards cancer risk and healthy foods, cognitive tendencies, as well as waist-to-hip ratio across a one-month baseline. Secondary outcomes encompass performance on an inhibitory control task with personal risk cues, the need for cognition self-report questionnaire (with scores ranging from -4 to +4), and an index of body morphology based on external measurements." - Anonymous Online Contributor
Unverified Answer
How many participants are currently enrolled in this research project?
"Affirmative. According to clinicaltrials.gov, this medical trial has been open since May 1st 2018 and is actively recruiting patients. An estimated 300 subjects are required at a single site of study." - Anonymous Online Contributor
Unverified Answer
Is there an ongoing opportunity to join this medical research?
"Per clinicaltrials.gov, this medical trial is actively recruiting; the post was first launched on May 1st 2018 and most recently revised on September 7th 2022." - Anonymous Online Contributor
Unverified Answer
Does the trial include individuals of legal age?
"The criteria for joining this clinical trial stipulates that enrollees must be between 18 and 60 years old. Separately, 115 trials are recruiting minors while 639 studies accept participants over the age of 65." - Anonymous Online Contributor
Unverified Answer
What prerequisites must an individual meet to be eligible for this trial?
"This study is recruiting 300 participants between 18 and 60 years of age who have malignancies. The primary prerequisite for eligibility is falling within the overweight to obese range (BMI 25-35)." - Anonymous Online Contributor
Unverified Answer