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

March 8, 2023 updated by: Medical University of Graz

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • Recruiting
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • students in participating schools

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
No intervention, but assessment of cardiometabolic health and cognition
Experimental: Intervention Group
Implementing a daily 45-minute physical activity session as an integral part of learning.
Behavioral: 45-minute daily physical activity
45-minute daily physical activity session as an integral part of learning (during regular school sessions)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

Kristiania University College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2021

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

September 1, 2025

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 28, 2021

First Posted (Actual)

July 9, 2021

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • HAPPY CHILDREN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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