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

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 Overview

• Status: Recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Active Implicit Priming; Behavioral: Control Implicit Priming; Behavioral: Food Exposure Task

• Study Type: Interventional
• Enrollment (Estimated): 228
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina Erpelding, BS; Phone Number: 303-724-8502; Email: christina.erpelding@cuanschutz.edu
• Study Contact Backup: Name: Kristina Legget, PhD; Phone Number: 303-724-5809; Email: kristina.legget@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Christina Erpelding, BS; Phone Number: 303-724-8502; Email: christina.erpelding@cuanschutz.edu
      • Contact: Kristina Legget, PhD; Phone Number: 303-724-5809; Email: kristina.legget@cuanschutz.edu
      • Principal Investigator: Jason Tregellas, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Implicit Priming; 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.	Behavioral: Active Implicit Priming; Approximately 10-minute behavioral intervention
Placebo Comparator: Control Implicit Priming; 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.	Behavioral: Control Implicit Priming; Approximately 10-minute behavioral intervention
Active Comparator: Food Exposure Task; 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.	Behavioral: Food Exposure Task; Approximately 10-30 minute behavioral intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 12 weeks
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.	Baseline, 12 weeks
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.	Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Body Weight	Percent change in body weight (kg) from baseline to after the 12-week intervention.	Baseline, 12 weeks
Change in Fat Mass	Change in fat mass, as measured using dual-energy x-ray absorptiometry, from baseline to after the 12-week intervention.	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Jason Tregellas, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Magnetic Resonance Imaging; Weight Loss; Brain; Body Weight; Neuroimaging; Food; Eating
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: 20-2821; R01DK125417 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No