Functional Magnetic Resonance ImagingNCT03735732
Neuronal Correlates of Priming on Goal-directed and Cue-dependent Behavior
An observational study of Functional Magnetic Resonance Imaging and Habits, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The current proposal aims to investigate neuronal correlates of implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Magnetic Resonance Imaging, Habits, Eating Behavior
- What is being tested?
- prime
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2019to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy lean and obese volunteers
Who may be able to join
- experimental: participants with obesity
- control: participants with normal-weight
Who cannot join
- currently dieting
- intolerance to provided food
- cognitive impairment
- contraindications for fMRI measurements
Trial locations and contacts
1 site in 1 country.
About this study
The current proposal aims to investigate neuronal correlates of implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior.
Read the detailed description
Food choice and intake is a daily and throughout normal subject. However, for more and more people eating habits and the question of food choice are of increasing interest and in several cases even a problem. The prevalence of obesity has tripled in the last decades and it is even spoken of an obesity epidemic. Life style interventions to lose weight often fail on the long run, also because people fall back into former unhealthy eating habits. Various factors influence our daily food choice, not all of which are apparent to ourselves. Thus, food choice might be goal-directed and therefore conscious and reflective, yet in other circumstances the choice to eat something specific might be based on cue dependent processes which are automatic and thus difficult to control. Since a change in eating-behavior and long-lasting weight loss is most problematic to achieve, the current proposal aims to investigate neuronal correlates of implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior.
- Being tested
- prime
- Medical subject headings
- Habits, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primeBehavioural
groups be confronted with health or palatability aspects of food items
| Study group | Role | What they receive |
|---|---|---|
| weight status | Not described | |
| mindset | Not described Receives: Behavioral: prime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neuronal correlates
Change of BOLD response measured by fMRI
Measured: before and 5 minutes after visually presented food items
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Feb 2019
- Primary completion1 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabine Frank, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735732
- Sponsor's protocol ID
- PIT_brain
- Status last verified
- Dec 2024
- First submitted
- 18 Jul 2018
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuronal Correlates of Priming on Goal-directed and Cue-dependent Behavior
- ClinicalTrials.gov ID
- NCT03735732
- Acronym / sponsor ID
- PIT_brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current proposal aims to investigate neuronal correlates of implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior.
Detailed description
Food choice and intake is a daily and throughout normal subject. However, for more and more people eating habits and the question of food choice are of increasing interest and in several cases even a problem. The prevalence of obesity has tripled in the last decades and it is even spoken of an obesity epidemic. Life style interventions to lose weight often fail on the long run, also because people fall back into former unhealthy eating habits. Various factors influence our daily food choice, not all of which are apparent to ourselves. Thus, food choice might be goal-directed and therefore conscious and reflective, yet in other circumstances the choice to eat something specific might be based on cue dependent processes which are automatic and thus difficult to control. Since a change in eating-behavior and long-lasting weight loss is most problematic to achieve, the current proposal aims to investigate neuronal correlates of implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| weight status | – | – |
| mindset | – | Behavioral: prime |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy lean and obese volunteers
Key inclusion criteria (2 listed)
- experimental: participants with obesity
- control: participants with normal-weight
Key exclusion criteria (4 listed)
- currently dieting
- intolerance to provided food
- cognitive impairment
- contraindications for fMRI measurements
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 |
|---|---|---|
| primegroups be confronted with health or palatability aspects of food items | Behavioural | mindset |
Primary outcome
Change in neuronal correlates
Time frame: before and 5 minutes after visually presented food items
Change of BOLD response measured by fMRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Magnetic Resonance Imaging and Habits, run by University Hospital Tuebingen at 1 site in Germany.
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 4 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 5 Dec 2024. 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 Germany. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 neuronal correlates (time frame: before and 5 minutes after visually presented food items). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2024.