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Neuronal and Behavioral Effects of Implicit Priming in Obese Individuals

Primary Purpose

Feeding Behavior, Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Implicit Priming
Control Implicit Priming
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Feeding Behavior

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Colorado Anschutz Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Active Implicit Priming (MRI sample)

Control Implicit Priming (MRI sample)

Active Implicit Priming (Behavioral-only sample)

Control Implicit Priming (Behavioral-only sample)

Arm Description

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.

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.

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.

Participants will complete a control implicit priming intervention, which matches the active intervention, but with neutral stimuli as primes.

Outcomes

Primary Outcome Measures

Change in Food Image Ratings
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.
Neuronal Response to Food Cues
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.

Secondary Outcome Measures

Food Intake
Food intake during ad-lib lunch (kcals)

Full Information

First Posted
January 16, 2015
Last Updated
August 11, 2022
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02347527
Brief Title
Neuronal and Behavioral Effects of Implicit Priming in Obese Individuals
Official Title
Neuronal and Behavioral Effects of Implicit Priming in Obese Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Behavior, Obesity, Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The "MRI sample" and "Behavioral-only sample" involve separate participants who complete the same intervention (assigned to either active or control groups), but the "MRI sample" also completed MRI outcomes and a food intake outcome that the "Behavioral-only sample" did not.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Implicit Priming (MRI sample)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Implicit Priming (MRI sample)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Active Implicit Priming (Behavioral-only sample)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Implicit Priming (Behavioral-only sample)
Arm Type
Placebo Comparator
Arm Description
Participants will complete a control implicit priming intervention, which matches the active intervention, but with neutral stimuli as primes.
Intervention Type
Behavioral
Intervention Name(s)
Active Implicit Priming
Intervention Description
A 10-minute implicit priming intervention, associating food images with images of positive or negative valence.
Intervention Type
Behavioral
Intervention Name(s)
Control Implicit Priming
Intervention Description
A 10-minute implicit priming intervention, associating food images with images of neutral valence.
Primary Outcome Measure Information:
Title
Change in Food Image Ratings
Description
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.
Time Frame
Baseline to within 10 minutes post-intervention
Title
Neuronal Response to Food Cues
Description
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.
Time Frame
Baseline to post-intervention
Secondary Outcome Measure Information:
Title
Food Intake
Description
Food intake during ad-lib lunch (kcals)
Time Frame
1 hour post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason R Tregellas, PhD
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristina T Legget, PhD
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35030242
Citation
Legget KT, Cornier MA, Erpelding C, Lawful BP, Bear JJ, Kronberg E, Tregellas JR. An implicit priming intervention alters brain and behavioral responses to high-calorie foods: a randomized controlled study. Am J Clin Nutr. 2022 Apr 1;115(4):1194-1204. doi: 10.1093/ajcn/nqac009.
Results Reference
derived
PubMed Identifier
26109580
Citation
Legget KT, Cornier MA, Rojas DC, Lawful B, Tregellas JR. Harnessing the power of disgust: a randomized trial to reduce high-calorie food appeal through implicit priming. Am J Clin Nutr. 2015 Aug;102(2):249-55. doi: 10.3945/ajcn.115.106955. Epub 2015 Jun 24.
Results Reference
derived

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Neuronal and Behavioral Effects of Implicit Priming in Obese Individuals

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