Overweight and ObesityNCT05107908
Neuronal and Behavioral Effects of an Implicit Priming Approach to Improve Eating Behaviors in Obesity
A study testing Active Implicit Priming and Food Exposure Task in people with Overweight and Obesity, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Active Implicit Priming and Food Exposure Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2021to 8 Sep 2026
- Phase
- Interventional
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years old
- BMI of 27 or greater
Who cannot join
- MRI contraindications (e.g., metal or electronic devices in the body)
- Pregnancy
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 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
- Being tested
- Active Implicit Priming, Control Implicit Priming, Food Exposure Task
- Keywords
- Eating, Overweight, Obesity, Food, Weight Loss, Magnetic Resonance Imaging, Neuroimaging, Brain, Body Weight
- Medical subject headings
- Overweight, Obesity, Weight Loss, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Implicit PrimingBehavioural
Approximately 10-minute behavioral intervention
Control Implicit PrimingBehavioural
Approximately 10-minute behavioral intervention
Food Exposure TaskBehavioural
Approximately 10-30 minute behavioral intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Food Exposure Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 weeks
Secondary outcomes (2)
Percent Change in Body Weight
Percent change in body weight (kg) from baseline to after the 12-week intervention.
Measured: Baseline, 12 weeks
Change in Fat Mass
Change in fat mass, as measured using dual-energy x-ray absorptiometry, from baseline to after the 12-week intervention.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start12 Nov 2021
- Primary completion8 Sep 2026
- Study completion8 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Tregellas, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107908
- Sponsor's protocol ID
- 20-2821
- Other IDs
- R01DK125417
- Status last verified
- Oct 2026
- First submitted
- 3 Nov 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No