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Behavioral Intervention

Devaluing energy-dense foods for cancer-control for Obesity

N/A

Waitlist Available

Led By Elliot Berkman, Ph.D.

Research Sponsored by University of Oregon

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- overweight to obese range (BMI 25-35)

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month

Awards & highlights

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

Obesity
Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline Food Intake at 1 month using dietary assessment tool

Change from Baseline Food Intake at 1 month, Self-Report Questionnaire

Secondary outcome measures

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

+16 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive Reappraisal TrainingExperimental Treatment1 Intervention

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.

Group II: Behavioral Response TrainingExperimental Treatment1 Intervention

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.

Group III: Generic Response TrainingActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Devaluing energy-dense foods for cancer-control

2018

N/A

~260

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of OregonLead Sponsor

80 Previous Clinical Trials

46,506 Total Patients Enrolled

3 Trials studying Obesity

399 Patients Enrolled for Obesity

Elliot Berkman, Ph.D.Principal InvestigatorUniversity of Oregon

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

Recent research and studies

Journal of Consulting and Clinical PsychologyJournal

An Effectiveness Trial of a Dissonance-based Eating Disorder Prevention Program for High-risk Adolescent Girls.

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.

Physiology & BehaviorJournal

A Pilot Randomized Trial of a Cognitive Reappraisal Obesity Prevention Program

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.

Journal of Cognitive NeuroscienceJournal

Neural Systems Underlying the Reappraisal of Personally Craved Foods

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.

Behaviour Research and TherapyJournal