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Neuronal and Behavioral Effects of Implicit Priming in Obese Individuals

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ClinicalTrials.gov Identifier: NCT02347527
Recruitment Status : Recruiting
First Posted : January 27, 2015
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The overall goals of this project are to determine the impact of an implicit priming intervention, designed to alter food perceptions, on both brain responses to food and on food intake behaviors in overweight/obese individuals. The investigators hypothesized that this bottom-up sensory-level conditioning approach would effectively result in reduced preference for high-calorie foods.

Condition or disease Intervention/treatment Phase
Feeding Behavior Obesity Overweight Behavioral: Active Implicit Priming Behavioral: Control Implicit Priming Not Applicable

Detailed Description:

One factor that may contribute to susceptibility to obesity is a high responsivity to high-calorie foods in terms of cognitive factors such as emotional associations, reward value or reinforcing properties of food. Many of these processes involve learned associations thought to develop via classical conditioning through repeated pairings with external stimuli, which can influence food preferences and intake. As such, improving our understanding of the neuronal mechanisms underlying these processes and attempting to modify them may be a useful strategy to promote weight loss and maintenance. Therefore, the proposed study aims to investigate the effects of altering food perception on neuronal responses and food intake behaviors by using implicit priming, in which positively or negatively valenced images are presented immediately prior to food images, but are not consciously perceived.

The project goals are to determine the impact of the implicit priming intervention on both brain responses to food cues and on food intake behaviors in overweight/obese individuals. Food image ratings and neuronal responses to visual food cues will be assessed before and after either (a) an active implicit priming intervention or (b) a control intervention. Following fMRI, food intake will be measured.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Neuronal and Behavioral Effects of Implicit Priming in Obese Individuals
Study Start Date : May 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Active Implicit Priming
Participants will complete active implicit priming, in which food images are implicitly primed (i.e., below conscious awareness) with images of positive or negative affect.
Behavioral: Active Implicit Priming
A 10-minute implicit priming intervention, associating food images with images of positive or negative valence.

Placebo Comparator: Control Implicit Priming
Participants will complete a control implicit priming intervention, which matches the active intervention, but with neutral stimuli as primes.
Behavioral: Control Implicit Priming
A 10-minute implicit priming intervention, associating food images with images of neutral valence.




Primary Outcome Measures :
  1. Change in Food Image Ratings [ Time Frame: Baseline to within 10 minutes post-intervention ]
    Food image ratings change from baseline, measured within 10 minutes post-intervention. Food images are rated on "desire to eat" by visual analogue scale (0-100).

  2. Neuronal Response to Food Cues [ Time Frame: Baseline to peak insula response (within 20 minutes post-intervention) ]
    Neuronal response while viewing visual food cues will be measured using functional magnetic resonance imaging (fMRI). Primary outcome is peak insula response change from baseline, as measured within 20 minutes after the intervention.


Secondary Outcome Measures :
  1. Measure of Food Intake [ Time Frame: 1 hour post-intervention ]
    Ad libitum food intake measure



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overweight/obese adults
  • Healthy weight adults

Exclusion Criteria:

  • Vegetarian, vegan, or having other wide-ranging food restrictions
  • Currently dieting

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347527


Contacts
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Contact: Jason R Tregellas, PhD 303-724-6232 jason.tregellas@ucdenver.edu
Contact: Kristina T Legget, PhD 303-724-5809 kristina.legget@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Kristina T Legget, PhD    303-724-5809    kristina.legget@ucdenver.edu   
Contact: Jason R Tregellas, PhD    303-724-6232    jason.tregellas@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Jason R Tregellas, PhD University of Colorado - Anschutz Medical Campus
Principal Investigator: Kristina T Legget, PhD University of Colorado - Anschutz Medical Campus

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02347527     History of Changes
Other Study ID Numbers: 13-1786
R21DK102052 ( U.S. NIH Grant/Contract )
P30DK048520 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms