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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Physical Activity, Cardiometabolic Health

Intervention / Treatment
-----------------
* Behavioral: 45-minute daily physical activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: students in participating schools Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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