NCT02347527

Brief Summary

The overall goals of this project are to determine the impact of an implicit priming intervention, designed to alter food perceptions, on both brain responses to food and on food intake behaviors in overweight/obese individuals. The investigators hypothesized that this bottom-up sensory-level conditioning approach would effectively result in reduced preference for high-calorie foods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

September 7, 2022

Completed
Last Updated

September 7, 2022

Status Verified

August 1, 2022

Enrollment Period

6.3 years

First QC Date

January 16, 2015

Results QC Date

August 11, 2022

Last Update Submit

August 11, 2022

Conditions

Feeding BehaviorObesityOverweight

Outcome Measures

Primary Outcomes (2)

  • Change in Food Image Ratings

    Food image ratings (high-calorie foods) change from baseline, measured within 10 minutes post-intervention. Food images are rated on "desire to eat" by visual analogue scale (0-100; higher scores mean greater desire to eat). Negative values indicate reduced scores post-intervention compared to baseline, with greater numbers indicating greater reduction.

    Baseline to within 10 minutes post-intervention

  • Neuronal Response to Food Cues

    Neuronal response while viewing visual food cues will be measured using functional magnetic resonance imaging (fMRI). Primary outcome was insula response change from baseline, as measured within 20 minutes after the intervention. A bilateral region of interest (ROI) for the insula was defined anatomically, with mean difference from baseline to post-intervention (% BOLD signal change) calculated across all voxels for that ROI. A positive number indicates a reduced response (with higher numbers indicating greater change) and a negative number indicates an increased response.

    Baseline to post-intervention

Secondary Outcomes (1)

  • Food Intake

    1 hour post-intervention

Study Arms (4)

Active Implicit Priming (MRI sample)

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. In addition to measures of food image ratings, this group completed a visual food cues scan during fMRI to assess change in neuronal response to food cues. They also completed a measure of food intake post-intervention.

Behavioral: Active Implicit Priming

Control Implicit Priming (MRI sample)

PLACEBO COMPARATOR

Participants will complete a control implicit priming intervention, which matches the active intervention, but with neutral stimuli as primes. In addition to measures of food image ratings, this group completed a visual food cues scan during fMRI to assess change in neuronal response to food cues. They also completed a measure of food intake post-intervention.

Behavioral: Control Implicit Priming

Active Implicit Priming (Behavioral-only sample)

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.

Behavioral: Active Implicit Priming

Control Implicit Priming (Behavioral-only sample)

PLACEBO COMPARATOR

Participants will complete a control implicit priming intervention, which matches the active intervention, but with neutral stimuli as primes.

Behavioral: Control Implicit Priming

Interventions

Active Implicit PrimingBEHAVIORAL

A 10-minute implicit priming intervention, associating food images with images of positive or negative valence.

Active Implicit Priming (Behavioral-only sample)Active Implicit Priming (MRI sample)
Control Implicit PrimingBEHAVIORAL

A 10-minute implicit priming intervention, associating food images with images of neutral valence.

Control Implicit Priming (Behavioral-only sample)Control Implicit Priming (MRI sample)

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overweight/obese adults
  • Healthy weight adults

You may not qualify if:

  • Vegetarian, vegan, or having other wide-ranging food restrictions
  • Currently dieting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

  • Legget KT, Cornier MA, Erpelding C, Lawful BP, Bear JJ, Kronberg E, Tregellas JR. An implicit priming intervention alters brain and behavioral responses to high-calorie foods: a randomized controlled study. Am J Clin Nutr. 2022 Apr 1;115(4):1194-1204. doi: 10.1093/ajcn/nqac009.

    PMID: 35030242DERIVED

  • Legget KT, Cornier MA, Rojas DC, Lawful B, Tregellas JR. Harnessing the power of disgust: a randomized trial to reduce high-calorie food appeal through implicit priming. Am J Clin Nutr. 2015 Aug;102(2):249-55. doi: 10.3945/ajcn.115.106955. Epub 2015 Jun 24.

    PMID: 26109580DERIVED

MeSH Terms

Conditions

Feeding BehaviorObesityOverweight

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Kristina Legget
Organization
University of Colorado School of Medicine
kristina.legget@cuanschutz.edu
3037245809

Study Officials

  • Jason R Tregellas, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

  • Kristina T Legget, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The "MRI sample" and "Behavioral-only sample" involve separate participants who complete the same intervention (assigned to either active or control groups), but the "MRI sample" also completed MRI outcomes and a food intake outcome that the "Behavioral-only sample" did not.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 27, 2015

Study Start

May 1, 2013

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

September 7, 2022

Results First Posted

September 7, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)