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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04187066
Other study ID # PIT_BS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2019
Est. completion date December 31, 2023

Study information

Verified date May 2022
Source University Hospital Tuebingen
Contact Sabine Frank
Phone 004970712981193
Email s.frank@uni-tuebingen.de
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - experimental: severe obesity - control: normal weight Exclusion Criteria: - impaired cognitive functions, which might conflict with the task - appropriate German

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
mindset induction
induction of a health mindset to measure changes in cue-dependent and goal-directed behavior

Locations

Country Name City State
Germany University Clinic of Tuebingen, fMEG Center Tuebingen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 pre bariatric surgery, 1 month after bariatric surgery, 6 months after bariatric surgery
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