Eating BehaviorPIT_BSNCT04187066
Goal-directed and Cue-dependent Behavior in Severe Obesity
An observational study of Eating Behavior and Habits, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The current proposal aims to investigate implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior in participants with severe obesity before and after bariatric surgery as well as in a control group with normal weight. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior, Habits, Obesity
- What is being tested?
- mindset induction
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * experimental: severe obesity who might get a bariatric surgery * control: normal weight
Who may be able to join
- experimental: severe obesity
- control: normal weight
Who cannot join
- impaired cognitive functions, which might conflict with the task
- appropriate German
Trial locations and contacts
1 site in 1 country.
About this study
The current proposal aims to investigate implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior in participants with severe obesity before and after bariatric surgery as well as in a control group with normal weight.
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. Bariatric surgery is a very effective procedure to reduce weight fundamentally.
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. The aim of the current study is to investigate cue-dependent and goal-directed nutritional behavior as well as the effect of a health mindset induction in severe obesity as well as changes in such behaviors due to bariatric surgery.
- Conditions
- Eating Behavior, Habits, Obesity
- Being tested
- mindset induction
- Medical subject headings
- Feeding Behavior, Habits, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindset inductionBehavioural
induction of a health mindset to measure changes in cue-dependent and goal-directed behavior
| Study group | Role | What they receive |
|---|---|---|
| Obese | severe obesity Receives: Behavioral: mindset induction | |
| Control | Control group with normal weight Receives: Behavioral: mindset induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in food choice behavior due to substantial weight loss by bariatric surgery
changes in cue-dependent and goal-directed food choices assessed by the Pavlovian-to-instrumental transfer task
Measured: pre bariatric surgery, 1 month after bariatric surgery, 6 months after bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Aug 2019
- Primary completion31 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 Eating BehaviorStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 50 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
- NCT04187066
- Sponsor's protocol ID
- PIT_BS
- Acronym
- PIT_BS
- Status last verified
- Dec 2024
- First submitted
- 26 Nov 2019
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal-directed and Cue-dependent Behavior in Severe Obesity
- ClinicalTrials.gov ID
- NCT04187066
- Acronym / sponsor ID
- PIT_BS / PIT_BS
- Conditions
- Eating Behavior, Habits, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 5 Dec 2019 (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 implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior in participants with severe obesity before and after bariatric surgery as well as in a control group with normal weight.
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. Bariatric surgery is a very effective procedure to reduce weight fundamentally.
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. The aim of the current study is to investigate cue-dependent and goal-directed nutritional behavior as well as the effect of a health mindset induction in severe obesity as well as changes in such behaviors due to bariatric surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese | – | Behavioral: mindset inductionsevere obesity |
| Control | – | Behavioral: mindset inductionControl group with normal weight |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * experimental: severe obesity who might get a bariatric surgery * control: normal weight
Key inclusion criteria (2 listed)
- experimental: severe obesity
- control: normal weight
Key exclusion criteria (2 listed)
- impaired cognitive functions, which might conflict with the task
- appropriate German
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 |
|---|---|---|
| mindset inductioninduction of a health mindset to measure changes in cue-dependent and goal-directed behavior | Behavioural | Control, Obese |
Primary outcome
changes in food choice behavior due to substantial weight loss by bariatric surgery
Time frame: pre bariatric surgery, 1 month after bariatric surgery, 6 months after bariatric surgery
changes in cue-dependent and goal-directed food choices assessed by the Pavlovian-to-instrumental transfer task
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 9 Dec 2024.
- 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.
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 Eating Behavior 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 2 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 9 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?
changes in food choice behavior due to substantial weight loss by bariatric surgery (time frame: pre bariatric surgery, 1 month after bariatric surgery, 6 months after bariatric surgery). 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 9 Dec 2024.