Cardiovascular DiseasesNCT03085498
Sportcheck Follow-Up
An observational study of Cardiovascular Diseases and Childhood Obesity, run by University of Basel at 1 site in Switzerland.
Trial summary
The study resembles a four-year follow-up on the influence of physical activity and fitness, blood pressure, BMI and stress on vascular health in primary schoolchildren. It examines the predictive value of retinal vessel diameters for the development of childhood hypertension. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Childhood Obesity, Hypertension
- How many people
- 280 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2017to 1 Oct 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 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study will be designed as a four-year follow-up of the 2014 Sportcheck. All first-graders of primary schools in the canton Basel-Stadt took part in measurements of height, body weight and physical fitness during physical education lesson. From the 1255 children, 540 (43%) were allowed by their parents to join additional measurements of blood pressure and retinal vessel diameters and filled in questionnaires. In the year 2018, all fifth-graders of Basel-Stadt will be invited to take part in the same measurements as in 2014. All children will again conduct physical fitness tests and measurements of height and body weight during physical education. All children with an informed consent will participate in the same medical tests that were performed four years previously.
Who may be able to join
- All fifth-graders of public primary schools in Basel-Stadt with an informed consent signed by their parents are included.
Who cannot join
- Fifth-graders with motor-or other disabilities that do not allow participation will be excluded.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie
Basel, Canton of Basel-City, 4052
About this study
Official title: Sportcheck Follow-Up: Physical Fitness, Cardiovascular and Psychosocial Health in Primary School Childen
The study resembles a four-year follow-up on the influence of physical activity and fitness, blood pressure, BMI and stress on vascular health in primary schoolchildren. It examines the predictive value of retinal vessel diameters for the development of childhood hypertension.
Read the detailed description
The study aims to examine the usefulness of retinal vessel analysis in childhood cardiovascular prevention. It investigates the long-term influence of physical activity and fitness on retinal vessel diameters, blood pressure, BMI and psychosocial stress in children. The study aims to set new standards for an integrative primary prevention concept to initiate healthy ageing from childhood to adulthood.
- Conditions
- Cardiovascular Diseases, Childhood Obesity, Hypertension
- Being tested
- No intervention
- Keywords
- retinal vessels, physical activity, children, psychosocial health
- Medical subject headings
- Cardiovascular Diseases, Pediatric Obesity, Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal vessel diameter
To assess whether physical activity and fitness changes during the four-year follow-up influence retinal vessel diameters in children
Measured: Through study completion, an average of 1 year
Secondary outcomes (5)
Blood pressure
To assess whether physical activity and fitness changes during the four-year follow-up influence blood pressure in children
Measured: Through study completion, an average of 1 year
Body mass index (BMI)
To assess whether physical activity and fitness changes during the four-year follow-up influence BMI in children
Measured: Through study completion, an average of 1 year
Psychosocial stress exposure as assessed by the conflict subscale of the Family Environment Scale
To assess whether physical activity and fitness changes during the four-year follow-up influence psychosocial stress in children
Measured: Through study completion, an average of 1 year
Health behavior as assessed by the HBSC Symptom Checklist
To assess whether health behavior has changed during the four-year follow-up
Measured: Through study completion, an average of 1 year
Health-related quality of life as assessed by the KINDL-R questionnaire
To assess whether physical activity and fitness changes during the four-year follow-up influence health-related quality of life
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start1 Nov 2017
- Primary completion7 Jul 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Cross-sectional
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henner Hanssen, University of Basel
- Investigators
- Henner Hanssen, Prof. Dr., Principal investigator, University of BaselLukas Zahner, Prof. Dr., Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085498
- Sponsor's protocol ID
- EKNZ_258/12
- Status last verified
- Oct 2018
- First submitted
- 28 Feb 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lona G, Hauser C, Bade S, Kochli S, Infanger D, Endes K, Faude O, Hanssen H. Association of Parental Socioeconomic Status and Physical Activity with Development of Arterial Stiffness in Prepubertal Children. Int J Environ Res Public Health. 2021 Aug 3;18(15):8227. doi: 10.3390/ijerph18158227.
PubMed 34360513Lona G, Hauser C, Kochli S, Infanger D, Endes K, Faude O, Hanssen H. Blood Pressure Increase and Microvascular Dysfunction Accelerate Arterial Stiffening in Children: Modulation by Physical Activity. Front Physiol. 2020 Dec 17;11:613003. doi: 10.3389/fphys.2020.613003. eCollection 2020.
PubMed 33391029
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sportcheck Follow-Up: Physical Fitness, Cardiovascular and Psychosocial Health in Primary School Childen
- ClinicalTrials.gov ID
- NCT03085498
- Acronym / sponsor ID
- EKNZ_258/12
- Conditions
- Cardiovascular Diseases, Childhood Obesity, Hypertension
- Keywords
- retinal vessels, physical activity, children, psychosocial health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 7 Jul 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 21 Mar 2017 (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.
The study resembles a four-year follow-up on the influence of physical activity and fitness, blood pressure, BMI and stress on vascular health in primary schoolchildren. It examines the predictive value of retinal vessel diameters for the development of childhood hypertension.
Detailed description
The study aims to examine the usefulness of retinal vessel analysis in childhood cardiovascular prevention. It investigates the long-term influence of physical activity and fitness on retinal vessel diameters, blood pressure, BMI and psychosocial stress in children. The study aims to set new standards for an integrative primary prevention concept to initiate healthy ageing from childhood to adulthood.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study will be designed as a four-year follow-up of the 2014 Sportcheck. All first-graders of primary schools in the canton Basel-Stadt took part in measurements of height, body weight and physical fitness during physical education lesson. From the 1255 children, 540 (43%) were allowed by their parents to join additional measurements of blood pressure and retinal vessel diameters and filled in questionnaires. In the year 2018, all fifth-graders of Basel-Stadt will be invited to take part in the same measurements as in 2014. All children will again conduct physical fitness tests and measurements of height and body weight during physical education. All children with an informed consent will participate in the same medical tests that were performed four years previously.
Key inclusion criteria (1 listed)
- All fifth-graders of public primary schools in Basel-Stadt with an informed consent signed by their parents are included.
Key exclusion criteria (1 listed)
- Fifth-graders with motor-or other disabilities that do not allow participation will be excluded.
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 |
|---|---|---|
| No interventionno intervention | Other | – |
Primary outcome
Retinal vessel diameter
Time frame: Through study completion, an average of 1 year
To assess whether physical activity and fitness changes during the four-year follow-up influence retinal vessel diameters in children
5 secondary outcomes
Blood pressure
Time frame: Through study completion, an average of 1 year
Body mass index (BMI)
Time frame: Through study completion, an average of 1 year
Psychosocial stress exposure as assessed by the conflict subscale of the Family Environment Scale
Time frame: Through study completion, an average of 1 year
Health behavior as assessed by the HBSC Symptom Checklist
Time frame: Through study completion, an average of 1 year
Health-related quality of life as assessed by the KINDL-R questionnaire
Time frame: Through study completion, an average of 1 year
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 11 Oct 2018.
- Derived from this study: PubMed 34360513Lona G, Hauser C, Bade S, Kochli S, Infanger D, Endes K, Faude O, Hanssen H. Association of Parental Socioeconomic Status and Physical Activity with Development of Arterial Stiffness in Prepubertal Children. Int J Environ Res Public Health. 2021 Aug 3;18(15):8227. doi: 10.3390/ijerph18158227.
- Derived from this study: PubMed 33391029Lona G, Hauser C, Kochli S, Infanger D, Endes K, Faude O, Hanssen H. Blood Pressure Increase and Microvascular Dysfunction Accelerate Arterial Stiffening in Children: Modulation by Physical Activity. Front Physiol. 2020 Dec 17;11:613003. doi: 10.3389/fphys.2020.613003. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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.
Henner Hanssen, Prof. Dr. principal investigator
University of Basel
Lukas Zahner, Prof. Dr. principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Childhood Obesity, run by University of Basel at 1 site in Switzerland.
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 1 inclusion and 1 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 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Retinal vessel diameter (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03085498, which also lists 2 linked publications.
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 11 Oct 2018.