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NCT03988504 Clinical Trial

Impact of Predictive Genetic Testing

Quality of Life Clinical Trial

Official title:
Impact of Predictive Genetic Testing on Quality of Life and Health-related Behaviour

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03988504
Other study ID # RBK 358
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2016
Est. completion date January 31, 2018

Study information
Verified date June 2019
Source Robert Bosch Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Analysing Impact of preemptive genetic testing on quality of life, physical activity and eating behavior at baseline and 3 months after testing.

Recruitment information / eligibility
Status Completed
Enrollment 241
Est. completion date January 31, 2018
Est. primary completion date January 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age =18 years

- informed consent for genetic testing

- informed consent for study participation

Exclusion Criteria:

- Age <18 years

- renal replacement dependency

- pregnancy

- active cancer disease

- no informed consent for genetic testing or study participation

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Routine check up including genetic testing
Intervention is a routine check up including preemptive genetic testing

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Robert Bosch Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of Life assessed by the SF-36 questionnaire [followed by its scale information in the Description] Short form (36) (SF-36) questionnaire evaluates health related quality of life (Scale 0-100) 3 months
Primary Physical activity assessed by the IPAQ questionnaire [followed by its scale information in the Description] International Physical Activity Questionnaire (IPAQ) evaluates physical activity in MET(metabolic equivalent)/min/week 3 months
Primary Eating behavior assessed by the modified LEI questionnaire [followed by its scale information in the Description] The modified Luzerner Ernaehrungs Index (LEI) questionnaire evaluates eating behavior at lunch (Scale 1-4 per item; 1=never; 4=daily) 3 months
Secondary Satisfaction with check up and genetic testing: Likert scale (1-10) Likert scale (1-10) 3 months
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