NCT04956003

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 15, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 27, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

June 15, 2021

Last Update Submit

March 8, 2023

Conditions

Physical ActivityCardiometabolic Health

Outcome Measures

Primary Outcomes (10)

  • 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)

Study Arms (2)

Control Group

NO INTERVENTION

No intervention, but assessment of cardiometabolic health and cognition

Intervention Group

EXPERIMENTAL

Implementing a daily 45-minute physical activity session as an integral part of learning.

Behavioral: 45-minute daily physical activity

Interventions

45-minute daily physical activityBEHAVIORAL

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

Intervention Group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • students in participating schools

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, Styria, 8036, Austria

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28454531BACKGROUND

  • Goswami N, Hansen D, Gumze G, Brix B, Schmid-Zalaudek K, Fredriksen PM. Health and Academic Performance With Happy Children: A Controlled Longitudinal Study Based on the HOPP Project. Front Cardiovasc Med. 2022 Jun 3;9:820827. doi: 10.3389/fcvm.2022.820827. eCollection 2022.

    PMID: 35722126DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Nandu Goswami, Dr.

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nandu Goswami, Dr.

CONTACT

+43 664 7924948nandu.goswami@medunigraz.at

Karin Schmid Zalaudek, Dr.

CONTACT

+43 676 7204142karin.schmid@medunigraz.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2021

First Posted

July 9, 2021

Study Start

September 27, 2021

Primary Completion

October 1, 2024

Study Completion

September 1, 2025

Last Updated

March 9, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)