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| ID | Type | Description | Link |
|---|---|---|---|
| R21DK102052 | U.S. NIH Grant/Contract | View source | |
| P30DK048520 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Implicit Priming (MRI sample) | Experimental | 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. |
|
| Control Implicit Priming (MRI sample) | Placebo Comparator | 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. |
|
| Active Implicit Priming (Behavioral-only sample) | Experimental | 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. |
|
| Control Implicit Priming (Behavioral-only sample) | Placebo Comparator | Participants will complete a control implicit priming intervention, which matches the active intervention, but with neutral stimuli as primes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Implicit Priming | Behavioral | A 10-minute implicit priming intervention, associating food images with images of positive or negative valence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to within 10 minutes post-intervention |
| 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. | Baseline to post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Food Intake | Food intake during ad-lib lunch (kcals) | 1 hour post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason R Tregellas, PhD | University of Colorado, Denver | Principal Investigator |
| Kristina T Legget, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35030242 | Derived | 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. | |
| 26109580 | Derived | 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. |
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47 participants were in the "MRI sample" and 45 were in the "Behavioral-only sample," for a total of 92 unique study participants.
For the "Behavioral-Only" sample, participants were recruited via flyer advertisement in Aurora, CO, between May 2013 and March 2014. For the "MRI" sample, participants were recruited via email and flyer advertisement in Aurora, CO, between May 2015 and August 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Implicit Priming (MRI Sample) | Participants completed active implicit priming, in which food images were implicitly primed (i.e., below conscious awareness) with images of positive or negative affect. This group completed the priming intervention during fMRI scanning. Active Implicit Priming: A 10-minute implicit priming intervention, associating food images with images of positive or negative valence. |
| FG001 | Control Implicit Priming (MRI Sample) | Participants completed a control implicit priming intervention, which matched the active intervention, but with neutral stimuli as primes. This group completed the priming intervention during fMRI scanning. Control Implicit Priming: A 10-minute implicit priming intervention, associating food images with images of neutral valence. |
| FG002 | Active Implicit Priming (Behavioral-only Sample) | Participants completed active implicit priming, in which food images were implicitly primed (i.e., below conscious awareness) with images of positive or negative affect. Active Implicit Priming: A 10-minute implicit priming intervention, associating food images with images of positive or negative valence. |
| FG003 | Control Implicit Priming (Behavioral-only Sample) | Participants completed active implicit priming, in which food images were implicitly primed (i.e., below conscious awareness) with images of positive or negative affect. Active Implicit Priming: A 10-minute implicit priming intervention, associating food images with images of positive or negative valence. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Implicit Priming (MRI Sample) | Participants completed active implicit priming, in which food images were implicitly primed (i.e., below conscious awareness) with images of positive or negative affect. This group completed the intervention during fMRI scan. Active Implicit Priming: A 10-minute implicit priming intervention, associating food images with images of positive or negative valence. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | Score change from baseline | Baseline to within 10 minutes post-intervention |
|
Adverse event data were collected throughout the one-day study day period.
Occurrence of adverse events was assessed on an ongoing, case-by-case basis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Implicit Priming (MRI Sample) | Participants completed active implicit priming, in which food images were implicitly primed (i.e., below conscious awareness) with images of positive or negative affect. Participants in this group completed the intervention during an fMRI scan. Active Implicit Priming: A 10-minute implicit priming intervention, associating food images with images of positive or negative valence. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kristina Legget | University of Colorado School of Medicine | 3037245809 | kristina.legget@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2015 | Aug 11, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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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.
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| Control Implicit Priming | Behavioral | A 10-minute implicit priming intervention, associating food images with images of neutral valence. |
|
| MRI stopped due to participant anxiety |
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| Excluded from analyses due to excess movement during MRI scan |
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| Excluded from analyses due to technical difficulties during the study visit |
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| Excluded from analyses due to non-compliance with study procedures |
|
| BG001 | Control Implicit Priming (MRI Sample) | Participants completed a control implicit priming intervention, which matched the active intervention, but with neutral stimuli as primes. This group completed the intervention during fMRI scan. Control Implicit Priming: A 10-minute implicit priming intervention, associating food images with images of neutral valence. |
| BG002 | Active Implicit Priming (Behavioral-only Sample) | Participants completed active implicit priming, in which food images were implicitly primed (i.e., below conscious awareness) with images of positive or negative affect. Active Implicit Priming: A 10-minute implicit priming intervention, associating food images with images of positive or negative valence. |
| BG003 | Control Implicit Priming (Behavioral-only Sample) | Participants completed a control implicit priming intervention, which matched the active intervention, but with neutral stimuli as primes. Control Implicit Priming: A 10-minute implicit priming intervention, associating food images with images of neutral valence. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Baseline food image ratings | Baseline ratings of high-calorie food cues on "desire to eat" (scale of 0-100, with higher numbers indicating higher desire to eat). | Due to technical difficulties, food cue ratings were not collected for 5 participants in the MRI sample groups (sample size for this measure for the MRI sample groups: active, n = 19; control n = 17). | Mean | Standard Deviation | units on a scale |
|
| OG001 | Control Implicit Priming (MRI Sample) | Participants completed a control implicit priming intervention, which matched the active intervention, but with neutral stimuli as primes.This group completed the intervention during an fMRI scan. Control Implicit Priming: A 10-minute implicit priming intervention, associating food images with images of neutral valence. |
| OG002 | Active Implicit Priming (Behavioral-only Sample) | Participants completed active implicit priming, in which food images were implicitly primed (i.e., below conscious awareness) with images of positive or negative affect. Active Implicit Priming: A 10-minute implicit priming intervention, associating food images with images of positive or negative valence. |
| OG003 | Control Implicit Priming (Behavioral-only Sample) | Participants completed a control implicit priming intervention, which matched the active intervention, but with neutral stimuli as primes. Control Implicit Priming: A 10-minute implicit priming intervention, associating food images with images of neutral valence. |
|
|
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| Primary | 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. | Posted | Mean | Standard Deviation | % BOLD signal change from baseline | Baseline to post-intervention |
|
|
|
|
| Secondary | Food Intake | Food intake during ad-lib lunch (kcals) | Posted | Mean | Standard Deviation | kcals | 1 hour post-intervention |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Control Implicit Priming (MRI Sample) | Participants completed a control implicit priming intervention, which matched the active intervention, but with neutral stimuli as primes. Participants in this group completed the intervention during an fMRI scan. Control Implicit Priming: A 10-minute implicit priming intervention, associating food images with images of neutral valence. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG002 | Active Implicit Priming (Behavioral-only Sample) | Participants completed active implicit priming, in which food images were implicitly primed (i.e., below conscious awareness) with images of positive or negative affect. Active Implicit Priming: A 10-minute implicit priming intervention, associating food images with images of positive or negative valence. | 0 | 22 | 0 | 22 | 0 | 22 |
| EG003 | Control Implicit Priming (Behavioral-only Sample) | Participants completed a control implicit priming intervention, which matched the active intervention, but with neutral stimuli as primes. Control Implicit Priming: A 10-minute implicit priming intervention, associating food images with images of neutral valence. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 0.92 |
| Other |