Neuronal and Behavioral Effects of Implicit Priming in Obese Individuals

August 11, 2022 updated by: University of Colorado, Denver
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.

Study Overview

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 were assessed before and after either (a) an active implicit priming intervention or (b) a control intervention. One group of participants (n = 47; "MRI sample") completed the intervention during an fMRI scan and completed a visual food cues task both before and after the intervention (during fMRI), to assess intervention-related change in neuronal responses to food cues. In this group, food intake measures were also taken following fMRI. In a separate group of participants (n = 45; "Behavioral-only sample"), the primary outcome measure was the change in food image ratings from pre- to post-intervention; fMRI and measures of food intake were not assessed in this group.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • 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 Locations

    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus

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

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Overweight/obese adults
  • Healthy weight adults

Exclusion Criteria:

  • Vegetarian, vegan, or having other wide-ranging food restrictions
  • Currently dieting
  • MRI exclusion criteria, if in MRI sample (e.g., claustrophobia, metal in the body)

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Implicit Priming (MRI sample)
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. In addition to measures of food image ratings, this group completed a visual food cues scan during fMRI to assess change in neuronal response to food cues. They also completed a measure of food intake post-intervention.
A 10-minute implicit priming intervention, associating food images with images of positive or negative valence.
Placebo Comparator: Control Implicit Priming (MRI sample)
Participants will complete a control implicit priming intervention, which matches the active intervention, but with neutral stimuli as primes. In addition to measures of food image ratings, this group completed a visual food cues scan during fMRI to assess change in neuronal response to food cues. They also completed a measure of food intake post-intervention.
A 10-minute implicit priming intervention, associating food images with images of neutral valence.
Experimental: Active Implicit Priming (Behavioral-only sample)
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.
A 10-minute implicit priming intervention, associating food images with images of positive or negative valence.
Placebo Comparator: Control Implicit Priming (Behavioral-only sample)
Participants will complete a control implicit priming intervention, which matches the active intervention, but with neutral stimuli as primes.
A 10-minute implicit priming intervention, associating food images with images of neutral valence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Food Image Ratings
Time Frame: Baseline to within 10 minutes post-intervention
Food image ratings (high-calorie foods) change from baseline, measured within 10 minutes post-intervention. Food images are rated on "desire to eat" by visual analogue scale (0-100; higher scores mean greater desire to eat). Negative values indicate reduced scores post-intervention compared to baseline, with greater numbers indicating greater reduction.
Baseline to within 10 minutes post-intervention
Neuronal Response to Food Cues
Time Frame: Baseline to post-intervention
Neuronal response while viewing visual food cues will be measured using functional magnetic resonance imaging (fMRI). Primary outcome was insula response change from baseline, as measured within 20 minutes after the intervention. A bilateral region of interest (ROI) for the insula was defined anatomically, with mean difference from baseline to post-intervention (% BOLD signal change) calculated across all voxels for that ROI. A positive number indicates a reduced response (with higher numbers indicating greater change) and a negative number indicates an increased response.
Baseline to post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food Intake
Time Frame: 1 hour post-intervention
Food intake during ad-lib lunch (kcals)
1 hour post-intervention

Collaborators and Investigators

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

Investigators

  • 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 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.

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)

May 1, 2013

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 26, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

August 11, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-1786
  • R21DK102052 (U.S. NIH Grant/Contract)
  • P30DK048520 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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