NCT04187066

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

5.3 years

First QC Date

November 26, 2019

Last Update Submit

December 4, 2024

Conditions

Eating BehaviorHabitsObesity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Obese

severe obesity

Behavioral: mindset induction

Control

Control group with normal weight

Behavioral: mindset induction

Interventions

mindset inductionBEHAVIORAL

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

ControlObese

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* experimental: severe obesity who might get a bariatric surgery * control: normal weight

You may qualify if:

  • experimental: severe obesity
  • control: normal weight

You may not qualify if:

  • impaired cognitive functions, which might conflict with the task
  • appropriate German

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic of Tuebingen, fMEG Center

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Feeding BehaviorHabitsObesity

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reserach Associate

Study Record Dates

First Submitted

November 26, 2019

First Posted

December 5, 2019

Study Start

August 1, 2019

Primary Completion

October 31, 2024

Study Completion

December 1, 2024

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)