NCT03085498

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 28, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

8 months

First QC Date

February 28, 2017

Last Update Submit

October 10, 2018

Conditions

Keywords

retinal vesselsphysical activitychildrenpsychosocial health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Blood pressure

    Through study completion, an average of 1 year

  • Body mass index (BMI)

    Through study completion, an average of 1 year

  • Psychosocial stress exposure as assessed by the conflict subscale of the Family Environment Scale

    Through study completion, an average of 1 year

  • Health behavior as assessed by the HBSC Symptom Checklist

    Through study completion, an average of 1 year

  • Health-related quality of life as assessed by the KINDL-R questionnaire

    Through study completion, an average of 1 year

Interventions

no intervention

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie

Basel, Canton of Basel-City, 4052, Switzerland

Location

Related Publications (2)

  • 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.

  • Lona 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.

MeSH Terms

Conditions

Cardiovascular DiseasesPediatric ObesityHypertensionMotor Activity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesBehavior

Study Officials

  • Henner Hanssen, Prof. Dr.

    University of Basel

    PRINCIPAL INVESTIGATOR
  • Lukas Zahner, Prof. Dr.

    University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Henner Hanssen

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 21, 2017

Study Start

November 1, 2017

Primary Completion

July 7, 2018

Study Completion

October 1, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations