Impact of Predictive Genetic Testing

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

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Physical Activity; Genetic Testing
• Intervention / Treatment: Diagnostic test: Routine check up including genetic testing

• Study Type: Observational
• Enrollment (Actual): 241

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy subjects with request for health check up at Robert-Bosch-Hospital

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with check up and genetic testing: Likert scale (1-10)	Likert scale (1-10)	3 months

Collaborators and Investigators

• Sponsor: Robert Bosch Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 14, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: RBK 358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: On request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No