Back to resultsNeuronal and Behavioral Effects of an Implicit Priming Approach to Improve Eating Behaviors in Obesity
Primary Purpose
Overweight and Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Implicit Priming
Control Implicit Priming
Food Exposure Task
Sponsored by
About this trial
This is an interventional other trial for Overweight and Obesity focused on measuring Eating, Overweight, Obesity, Food, Weight Loss, Magnetic Resonance Imaging, Neuroimaging, Brain, Body Weight
Eligibility Criteria
Inclusion Criteria:
- 18-65 years old
- BMI of 27 or greater
Exclusion Criteria:
- MRI contraindications (e.g., metal or electronic devices in the body)
- Pregnancy
Sites / Locations
- University of Colorado Anschutz Medical CampusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
Active Implicit Priming
Control Implicit Priming
Food Exposure Task
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. This will be completed on a weekly basis for 12 weeks, for approximately 10 minutes each time.
Participants will complete control implicit priming, which matches the active intervention, but with neutral stimuli as primes. This will be completed on a weekly basis for 12 weeks, for approximately 10 minutes each time.
Participants will complete a Food Exposure Task, in which they will be asked to smell, feel, lick, and imagine eating food items, but without actually eating them. This will be completed on a weekly basis for 12 weeks, for approximately 10-30 minutes each time.
Outcomes
Primary Outcome Measures
Percent Change in Blood Oxygen Level Dependent (BOLD) Response to Visual Food Cues as Measured by Functional Magnetic Resonance Imaging
Percent change in blood oxygen level dependent (BOLD) response from baseline to after the 12-week intervention while viewing visual food cues will be measured using functional magnetic resonance imaging (fMRI), focusing on insula, striatum, and prefrontal cortex.
Change in Food Image Ratings
Food image ratings change from baseline to after the 12-week intervention. Food images are rated on "desire to eat" by visual analogue scale (0-100), with higher scores indicating greater desire to eat.
Change in Food Intake
Food intake change from baseline to after the 12-week intervention. Food intake will be measured as total calories consumed during an ad libitum meal.
Secondary Outcome Measures
Percent Change in Body Weight
Percent change in body weight (kg) from baseline to after the 12-week intervention.
Change in Fat Mass
Change in fat mass, as measured using dual-energy x-ray absorptiometry, from baseline to after the 12-week intervention.
Full Information
NCT ID
NCT05107908
First Posted
November 3, 2021
Last Updated
December 19, 2022
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT05107908
Brief Title
Neuronal and Behavioral Effects of an Implicit Priming Approach to Improve Eating Behaviors in Obesity
Official Title
Neuronal and Behavioral Effects of an Implicit Priming Approach to Improve Eating Behaviors in Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2021 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
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
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to determine how different behavioral interventions designed to alter food perceptions and behaviors affect brain responses to food, eating behaviors, and body weight.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Eating, Overweight, Obesity, Food, Weight Loss, Magnetic Resonance Imaging, Neuroimaging, Brain, Body Weight
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
228 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Implicit Priming
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. This will be completed on a weekly basis for 12 weeks, for approximately 10 minutes each time.
Arm Title
Control Implicit Priming
Arm Type
Placebo Comparator
Arm Description
Participants will complete control implicit priming, which matches the active intervention, but with neutral stimuli as primes. This will be completed on a weekly basis for 12 weeks, for approximately 10 minutes each time.
Arm Title
Food Exposure Task
Arm Type
Active Comparator
Arm Description
Participants will complete a Food Exposure Task, in which they will be asked to smell, feel, lick, and imagine eating food items, but without actually eating them. This will be completed on a weekly basis for 12 weeks, for approximately 10-30 minutes each time.
Intervention Type
Behavioral
Intervention Name(s)
Active Implicit Priming
Intervention Description
Approximately 10-minute behavioral intervention
Intervention Type
Behavioral
Intervention Name(s)
Control Implicit Priming
Intervention Description
Approximately 10-minute behavioral intervention
Intervention Type
Behavioral
Intervention Name(s)
Food Exposure Task
Intervention Description
Approximately 10-30 minute behavioral intervention
Primary Outcome Measure Information:
Title
Percent Change in Blood Oxygen Level Dependent (BOLD) Response to Visual Food Cues as Measured by Functional Magnetic Resonance Imaging
Description
Percent change in blood oxygen level dependent (BOLD) response from baseline to after the 12-week intervention while viewing visual food cues will be measured using functional magnetic resonance imaging (fMRI), focusing on insula, striatum, and prefrontal cortex.
Time Frame
Baseline, 12 weeks
Title
Change in Food Image Ratings
Description
Food image ratings change from baseline to after the 12-week intervention. Food images are rated on "desire to eat" by visual analogue scale (0-100), with higher scores indicating greater desire to eat.
Time Frame
Baseline, 12 weeks
Title
Change in Food Intake
Description
Food intake change from baseline to after the 12-week intervention. Food intake will be measured as total calories consumed during an ad libitum meal.
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Percent Change in Body Weight
Description
Percent change in body weight (kg) from baseline to after the 12-week intervention.
Time Frame
Baseline, 12 weeks
Title
Change in Fat Mass
Description
Change in fat mass, as measured using dual-energy x-ray absorptiometry, from baseline to after the 12-week intervention.
Time Frame
Baseline, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18-65 years old
BMI of 27 or greater
Exclusion Criteria:
MRI contraindications (e.g., metal or electronic devices in the body)
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Erpelding, BS
Phone
303-724-8502
Email
christina.erpelding@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Legget, PhD
Phone
303-724-5809
Email
kristina.legget@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Tregellas, PhD
Organizational Affiliation
University of Colorado, Denver
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Erpelding, BS
Phone
303-724-8502
Email
christina.erpelding@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Kristina Legget, PhD
Phone
303-724-5809
Email
kristina.legget@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Jason Tregellas, PhD
12. IPD Sharing Statement
Learn more about this trial
Neuronal and Behavioral Effects of an Implicit Priming Approach to Improve Eating Behaviors in Obesity
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