NCT03988504

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
241

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

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

September 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
Last Updated

June 17, 2019

Status Verified

June 1, 2019

Enrollment Period

1.4 years

First QC Date

June 12, 2019

Last Update Submit

June 14, 2019

Conditions

Genetic TestingQuality of LifePhysical Activity

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Satisfaction with check up and genetic testing: Likert scale (1-10)

    3 months

Interventions

Routine check up including genetic testingDIAGNOSTIC_TEST

Intervention is a routine check up including preemptive genetic testing

Eligibility Criteria

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

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

You may qualify if:

  • Age ≥18 years
  • informed consent for genetic testing
  • informed consent for study participation

You may not qualify if:

  • Age \<18 years
  • renal replacement dependency
  • pregnancy
  • active cancer disease
  • no informed consent for genetic testing or study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Managing Director

Study Record Dates

First Submitted

June 12, 2019

First Posted

June 17, 2019

Study Start

September 1, 2016

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

June 17, 2019

Record last verified: 2019-06