Feeding BehaviorNCT02347527
Neuronal and Behavioral Effects of Implicit Priming in Obese Individuals
A study testing Active Implicit Priming in people with Feeding Behavior and Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Feeding Behavior, Obesity, Overweight
- What is being tested?
- Active Implicit Priming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight/obese adults
- Healthy weight adults
Who cannot join
- Vegetarian, vegan, or having other wide-ranging food restrictions
- Currently dieting
- MRI exclusion criteria, if in MRI sample (e.g., claustrophobia, metal in the body)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
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.
Read the detailed description
One factor that may contribute to susceptibility to obesity is a high responsivity to high-calorie foods in terms of cognitive factors such as emotional associations, reward value or reinforcing properties of food. Many of these processes involve learned associations thought to develop via classical conditioning through repeated pairings with external stimuli, which can influence food preferences and intake. As such, improving our understanding of the neuronal mechanisms underlying these processes and attempting to modify them may be a useful strategy to promote weight loss and maintenance. Therefore, the proposed study aims to investigate the effects of altering food perception on neuronal responses and food intake behaviors by using implicit priming, in which positively or negatively valenced images are presented immediately prior to food images, but are not consciously perceived.
The project goals are to determine the impact of the implicit priming intervention on both brain responses to food cues and on food intake behaviors in overweight/obese individuals. Food image ratings were assessed before and after either (a) an active implicit priming intervention or (b) a control intervention. One group of participants (n = 47; "MRI sample") completed the intervention during an fMRI scan and completed a visual food cues task both before and after the intervention (during fMRI), to assess intervention-related change in neuronal responses to food cues. In this group, food intake measures were also taken following fMRI. In a separate group of participants (n = 45; "Behavioral-only sample"), the primary outcome measure was the change in food image ratings from pre- to post-intervention; fMRI and measures of food intake were not assessed in this group.
- Conditions
- Feeding Behavior, Obesity, Overweight
- Being tested
- Active Implicit Priming, Control Implicit Priming
- Medical subject headings
- Feeding Behavior, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Implicit PrimingBehavioural
A 10-minute implicit priming intervention, associating food images with images of positive or negative valence.
Control Implicit PrimingBehavioural
A 10-minute implicit priming intervention, associating food images with images of neutral valence.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Control Implicit Priming |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to post-intervention
Secondary outcomes (1)
Food Intake
Food intake during ad-lib lunch (kcals)
Measured: 1 hour post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startMay 2013
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Feeding BehaviorStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason R Tregellas, PhD, Principal investigator, University of Colorado, DenverKristina T Legget, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347527
- Sponsor's protocol ID
- 13-1786
- Other IDs
- R21DK102052, P30DK048520
- Status last verified
- Aug 2022
- First submitted
- 16 Jan 2015
- Last updated
- 7 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35030242Legget 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.
PubMed 26109580
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuronal and Behavioral Effects of Implicit Priming in Obese Individuals
- ClinicalTrials.gov ID
- NCT02347527
- Acronym / sponsor ID
- 13-1786
- Conditions
- Feeding Behavior, Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2013 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Posted 7 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
One factor that may contribute to susceptibility to obesity is a high responsivity to high-calorie foods in terms of cognitive factors such as emotional associations, reward value or reinforcing properties of food. Many of these processes involve learned associations thought to develop via classical conditioning through repeated pairings with external stimuli, which can influence food preferences and intake. As such, improving our understanding of the neuronal mechanisms underlying these processes and attempting to modify them may be a useful strategy to promote weight loss and maintenance. Therefore, the proposed study aims to investigate the effects of altering food perception on neuronal responses and food intake behaviors by using implicit priming, in which positively or negatively valenced images are presented immediately prior to food images, but are not consciously perceived.
The project goals are to determine the impact of the implicit priming intervention on both brain responses to food cues and on food intake behaviors in overweight/obese individuals. Food image ratings were assessed before and after either (a) an active implicit priming intervention or (b) a control intervention. One group of participants (n = 47; "MRI sample") completed the intervention during an fMRI scan and completed a visual food cues task both before and after the intervention (during fMRI), to assess intervention-related change in neuronal responses to food cues. In this group, food intake measures were also taken following fMRI. In a separate group of participants (n = 45; "Behavioral-only sample"), the primary outcome measure was the change in food image ratings from pre- to post-intervention; fMRI and measures of food intake were not assessed in this group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Implicit Priming (MRI sample) | Experimental | Behavioral: Active Implicit PrimingParticipants 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. |
| Control Implicit Priming (MRI sample) | Placebo comparator | Behavioral: Control Implicit PrimingParticipants 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. |
| Active Implicit Priming (Behavioral-only sample) | Experimental | Behavioral: Active Implicit PrimingParticipants will complete active implicit priming, in which food images are implicitly primed (i.e., below conscious awareness) with images of positive or negative affect. |
| Control Implicit Priming (Behavioral-only sample) | Placebo comparator | Behavioral: Control Implicit PrimingParticipants will complete a control implicit priming intervention, which matches the active intervention, but with neutral stimuli as primes. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Overweight/obese adults
- Healthy weight adults
Key exclusion criteria (3 listed)
- Vegetarian, vegan, or having other wide-ranging food restrictions
- Currently dieting
- MRI exclusion criteria, if in MRI sample (e.g., claustrophobia, metal in the body)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Implicit PrimingA 10-minute implicit priming intervention, associating food images with images of positive or negative valence. | Behavioural | Active Implicit Priming (Behavioral-only sample), Active Implicit Priming (MRI sample) |
| Control Implicit PrimingA 10-minute implicit priming intervention, associating food images with images of neutral valence. | Behavioural | Control Implicit Priming (Behavioral-only sample), Control Implicit Priming (MRI sample) |
Primary outcome
Change in Food Image Ratings
Time frame: Baseline to within 10 minutes post-intervention
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.
Neuronal Response to Food Cues
Time frame: Baseline to post-intervention
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.
1 secondary outcome
Food Intake
Time frame: 1 hour post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35030242Legget 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.
- Derived from this study: PubMed 26109580Legget 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason R Tregellas, PhD principal investigator
University of Colorado, Denver
Kristina T Legget, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Implicit Priming in people with Feeding Behavior and Obesity, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Food Image Ratings (time frame: Baseline to within 10 minutes post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02347527, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.