Goal-directed and Cue-dependent Behavior in Severe Obesity (PIT_BS)

May 17, 2022 updated by: Sabine Frank, University Hospital Tuebingen
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.

Study Overview

Status

Recruiting

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

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72076
        • Recruiting
        • University Clinic of Tuebingen, fMEG Center
        • Contact:
        • Principal Investigator:
          • Sabine Frank, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obese
severe obesity
Behavioral: mindset induction
induction of a health mindset to measure changes in cue-dependent and goal-directed behavior
Control
Control group with normal weight
Behavioral: mindset induction
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

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2019

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

November 26, 2019

First Submitted That Met QC Criteria

December 2, 2019

First Posted (ACTUAL)

December 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIT_BS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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