- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04187066
Goal-directed and Cue-dependent Behavior in Severe Obesity (PIT_BS)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Tuebingen, Germany, 72076
- University Clinic of Tuebingen, fMEG Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
- experimental: severe obesity who might get a bariatric surgery
- control: normal weight
Description
Inclusion Criteria:
- experimental: severe obesity
- control: normal weight
Exclusion Criteria:
- impaired cognitive functions, which might conflict with the task
- appropriate German
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Obese
severe obesity
|
induction of a health mindset to measure changes in cue-dependent and goal-directed behavior
|
|
Control
Control group with normal weight
|
induction of a health mindset to measure changes in cue-dependent and goal-directed behavior
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
pre bariatric surgery, 1 month after bariatric surgery, 6 months after bariatric surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PIT_BS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.