Sportcheck Follow-Up

Hypertension Clinical Trial

Official title:

Sportcheck Follow-Up: Physical Fitness, Cardiovascular and Psychosocial Health in Primary School Childen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03085498
• Other study ID #: EKNZ_258/12
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: October 2018
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: October 1, 2018
• Est. primary completion date: July 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 12 Years

Eligibility

Inclusion Criteria:

• All fifth-graders of public primary schools in Basel-Stadt with an informed consent signed by their parents are included.

Exclusion Criteria:

• Fifth-graders with motor-or other disabilities that do not allow participation will be excluded.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Childhood Obesity
• Hypertension
• Pediatric Obesity

Intervention

Other:
• No intervention
no intervention

Locations

Country	Name	City	State
Switzerland	Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal vessel diameter	To assess whether physical activity and fitness changes during the four-year follow-up influence retinal vessel diameters in children	Through study completion, an average of 1 year
Secondary	Blood pressure	To assess whether physical activity and fitness changes during the four-year follow-up influence blood pressure in children	Through study completion, an average of 1 year
Secondary	Body mass index (BMI)	To assess whether physical activity and fitness changes during the four-year follow-up influence BMI in children	Through study completion, an average of 1 year
Secondary	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	Through study completion, an average of 1 year
Secondary	Health behavior as assessed by the HBSC Symptom Checklist	To assess whether health behavior has changed during the four-year follow-up	Through study completion, an average of 1 year
Secondary	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	Through study completion, an average of 1 year