PIT_BS: Goal-directed and Cue-dependent Behavior in Severe Obesity

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04187066
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 53
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Eating Behavior; Habits; Obesity	Behavioral: mindset induction

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

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Goal-directed and Cue-dependent Behavior in Severe Obesity
• Actual Study Start Date: Aug 1, 2019
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. changes in food choice behavior due to substantial weight loss by bariatric surgery [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• experimental: severe obesity

• control: normal weight

Exclusion Criteria:

• impaired cognitive functions, which might conflict with the task

• appropriate German

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Clinic of Tuebingen, fMEG Center	Tuebingen		Germany	72076

Sponsors and Collaborators

• University Hospital Tuebingen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sabine Frank, Reserach Associate, University Hospital Tuebingen
• ClinicalTrials.gov Identifier: NCT04187066
• Other Study ID Numbers: PIT_BS
• First Posted: Dec 5, 2019
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity; Obesity, Morbid

Study Results

No Results Posted as of May 18, 2022