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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT05107908

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

228

Enrollment

Location

Arms

48.6

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Behavioral: Active Implicit Priming Behavioral: Control Implicit Priming Behavioral: Food Exposure Task	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

228 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 12, 2021

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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