Optimizing Cardiometabolic Health, Cognition and Academic Performance in Children (HAPHC)

Physical Activity Clinical Trial

Official title:

Optimizing Cardiometabolic Health, Cognition and Academic Performance With Happy Children (HAPHC) Using School-based Physical Activity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04956003
• Other study ID #: HAPPY CHILDREN
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: September 1, 2025

Study information

• Verified date: March 2023
• Source: Medical University of Graz
• Contact: Nandu Goswami, Dr.
• Phone: +43 664 7924948
• Email: nandu.goswami[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Children and young people are moving less and less. In combination with an unhealthy diet, this has led to a sharp increase in overweight and obesity among children worldwide. Very often, physical illnesses occur in adolescence that can be directly attributed to the overweight and obesity. In order to protect children from these consequences in time, a daily exercise unit of 45 minutes is built into their learning. This exercise will take place in addition to physical education classes as part of your child's school day and will be conducted by a teacher. We will examine the children of the participating schools with regard to health-related characteristics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: September 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• students in participating schools

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Cardiometabolic Health
• Physical Activity

Intervention

Behavioral:
• 45-minute daily physical activity
45-minute daily physical activity session as an integral part of learning (during regular school sessions)

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	Kristiania University College

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Fredriksen PM, Hjelle OP, Mamen A, Meza TJ, Westerberg AC. The health Oriented pedagogical project (HOPP) - a controlled longitudinal school-based physical activity intervention program. BMC Public Health. 2017 Apr 28;17(1):370. doi: 10.1186/s12889-017-4282-z. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular changes - heart rate	heart rate	3 years (4 yearly measurement time-points)
Primary	Cardiovascular changes - blood pressure	blood pressure	3 years (4 yearly measurement time-points)
Primary	Microcirculation	retinal camera (retinal imaging)	3 years (4 yearly measurement time-points)
Primary	Changes in subcutaneous adipose tissue	Assessment via ultrasound	3 years (4 yearly measurement time-points)
Primary	Changes in physical fitness - handgrip	Strength via handgrip measurement	3 years (4 yearly measurement time-points)
Primary	Changes in physical fitness - running	Endurance via interval running test for 10 minutes	3 years (4 yearly measurement time-points)
Primary	Changes in physical fitness - coordination	coordination tested via Dordel-Koch-Test	3 years (4 yearly measurement time-points)
Primary	Changes in cognitive performance parameters - concentration	concentration tests	3 years (4 yearly measurement time-points)
Primary	Changes in cognitive performance parameters - reading	reading comprehension via regular school tests	3 years (4 yearly measurement time-points)
Primary	Changes in cognitive performance parameters - mathematics	mathematics via regular school tests	3 years (4 yearly measurement time-points)