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

NCT05107908 | Recruiting

• 2 other identifiers: 20-2821R01DK125417
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Eating; Overweight; Obesity; Food; Weight Loss; Magnetic Resonance Imaging; Neuroimaging; Brain; Body Weight

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Percent Change in Body Weight

  Baseline, 12 weeks

• Change in Fat Mass

  Baseline, 12 weeks

Study Arms (3)

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.

Behavioral: Active Implicit Priming

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.

Behavioral: Control Implicit Priming

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.

Behavioral: Food Exposure Task

Interventions

Active Implicit Priming BEHAVIORAL

Approximately 10-minute behavioral intervention

Active Implicit Priming

Control Implicit Priming BEHAVIORAL

Approximately 10-minute behavioral intervention

Control Implicit Priming

Food Exposure Task BEHAVIORAL

Approximately 10-30 minute behavioral intervention

Food Exposure Task

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• BMI of 27 or greater

You may not qualify if:

• MRI contraindications (e.g., metal or electronic devices in the body)
• Pregnancy

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss; Body Weight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Jason Tregellas, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Erpelding, BS

CONTACT

303-724-8502; christina.erpelding@cuanschutz.edu

Kristina Legget, PhD

CONTACT

303-724-5809; kristina.legget@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 4, 2021
• Study Start: November 12, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (1)