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Clinical Trials/NCT05107908
NCT05107908RecruitingNot Applicable

Neuronal and Behavioral Effects of an Implicit Priming Approach to Improve Eating Behaviors in Obesity

University of Colorado, Denver1 site in 1 country228 target enrollmentStarted: November 12, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
228
Locations
1
Primary Endpoint
Percent Change in Blood Oxygen Level Dependent (BOLD) Response to Visual Food Cues as Measured by Functional Magnetic Resonance Imaging

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Active Implicit Priming

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. This will be completed on a weekly basis for 12 weeks, for approximately 10 minutes each time.

Intervention: Active Implicit Priming (Behavioral)

Control Implicit Priming

Placebo Comparator

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.

Intervention: Control Implicit Priming (Behavioral)

Food Exposure Task

Active Comparator

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: Food Exposure Task (Behavioral)

Outcomes

Primary Outcomes

Percent Change in Blood Oxygen Level Dependent (BOLD) Response to Visual Food Cues as Measured by Functional Magnetic Resonance Imaging

Time Frame: Baseline, 12 weeks

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

Time Frame: Baseline, 12 weeks

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

Time Frame: Baseline, 12 weeks

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 Outcomes

  • Percent Change in Body Weight(Baseline, 12 weeks)
  • Change in Fat Mass(Baseline, 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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