Genetic TestingNCT03988504
Impact of Predictive Genetic Testing
An observational study of Genetic Testing and Quality of Life, run by Robert Bosch Medical Center.
Trial summary
Analysing Impact of preemptive genetic testing on quality of life, physical activity and eating behavior at baseline and 3 months after testing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Genetic Testing, Quality of Life, Physical Activity
- What is being tested?
- Routine check up including genetic testing
- How many people
- 241 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 31 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects with request for health check up at Robert-Bosch-Hospital
Who may be able to join
- Age ≥18 years
- informed consent for genetic testing
- informed consent for study participation
Who cannot join
- Age <18 years
- renal replacement dependency
- pregnancy
- active cancer disease
- no informed consent for genetic testing or study participation
About this study
Official title: 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.
- Conditions
- Genetic Testing, Quality of Life, Physical Activity
- Being tested
- Routine check up including genetic testing
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine check up including genetic testingDiagnostic test
Intervention is a routine check up including preemptive genetic testing
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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)
Measured: 3 months
Secondary outcomes (1)
Satisfaction with check up and genetic testing: Likert scale (1-10)
Likert scale (1-10)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start1 Sep 2016
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Bosch Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Mark Dominik Alscher, Robert Bosch Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988504
- Sponsor's protocol ID
- RBK 358
- Status last verified
- Jun 2019
- First submitted
- 12 Jun 2019
- Last updated
- 17 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: On request
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Predictive Genetic Testing on Quality of Life and Health-related Behaviour
- ClinicalTrials.gov ID
- NCT03988504
- Acronym / sponsor ID
- RBK 358
- Conditions
- Genetic Testing, Quality of Life, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Robert Bosch Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Analysing Impact of preemptive genetic testing on quality of life, physical activity and eating behavior at baseline and 3 months after testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects with request for health check up at Robert-Bosch-Hospital
Key inclusion criteria (3 listed)
- Age ≥18 years
- informed consent for genetic testing
- informed consent for study participation
Key exclusion criteria (5 listed)
- Age <18 years
- renal replacement dependency
- pregnancy
- active cancer disease
- no informed consent for genetic testing or study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine check up including genetic testingIntervention is a routine check up including preemptive genetic testing | Diagnostic test | – |
Primary outcome
Quality of Life assessed by the SF-36 questionnaire [followed by its scale information in the Description]
Time frame: 3 months
Short form (36) (SF-36) questionnaire evaluates health related quality of life (Scale 0-100)
Physical activity assessed by the IPAQ questionnaire [followed by its scale information in the Description]
Time frame: 3 months
International Physical Activity Questionnaire (IPAQ) evaluates physical activity in MET(metabolic equivalent)/min/week
Eating behavior assessed by the modified LEI questionnaire [followed by its scale information in the Description]
Time frame: 3 months
The modified Luzerner Ernaehrungs Index (LEI) questionnaire evaluates eating behavior at lunch (Scale 1-4 per item; 1=never; 4=daily)
1 secondary outcome
Satisfaction with check up and genetic testing: Likert scale (1-10)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Individual participant dataSharing planned: Undecided. On request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Testing and Quality of Life, run by Robert Bosch Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life assessed by the SF-36 questionnaire [followed by its scale information in the Description] (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019; AzTrials last refreshed its copy on 28 Oct 2026.