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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05107908
• Other study ID #: 20-2821
• Secondary ID: R01DK125417
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2021
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: University of Colorado, Denver
• Contact: Christina Erpelding, BS
• Phone: 303-724-8502
• Email: christina.erpelding[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Active Implicit Priming
Approximately 10-minute behavioral intervention
• Control Implicit Priming
Approximately 10-minute behavioral intervention
• Food Exposure Task
Approximately 10-30 minute behavioral intervention

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Percent Change in Body Weight	Percent change in body weight (kg) from baseline to after the 12-week intervention.	Baseline, 12 weeks
Secondary	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