Physical ActivityNCT04956003
Optimizing Cardiometabolic Health, Cognition and Academic Performance in Children (HAPHC)
A study testing 45-minute daily physical activity in people with Physical Activity and Cardiometabolic Health, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Cardiometabolic Health
- What is being tested?
- 45-minute daily physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteAustria
- Study dates
- 27 Sep 2021to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- students in participating schools
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Physical Activity, Cardiometabolic Health
- Being tested
- 45-minute daily physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
45-minute daily physical activityBehavioural
45-minute daily physical activity session as an integral part of learning (during regular school sessions)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: 45-minute daily physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular changes - heart rate
heart rate
Measured: 3 years (4 yearly measurement time-points)
Cardiovascular changes - blood pressure
blood pressure
Measured: 3 years (4 yearly measurement time-points)
Microcirculation
retinal camera (retinal imaging)
Measured: 3 years (4 yearly measurement time-points)
Changes in subcutaneous adipose tissue
Assessment via ultrasound
Measured: 3 years (4 yearly measurement time-points)
Changes in physical fitness - handgrip
Strength via handgrip measurement
Measured: 3 years (4 yearly measurement time-points)
Changes in physical fitness - running
Endurance via interval running test for 10 minutes
Measured: 3 years (4 yearly measurement time-points)
Changes in physical fitness - coordination
coordination tested via Dordel-Koch-Test
Measured: 3 years (4 yearly measurement time-points)
Changes in cognitive performance parameters - concentration
concentration tests
Measured: 3 years (4 yearly measurement time-points)
Changes in cognitive performance parameters - reading
reading comprehension via regular school tests
Measured: 3 years (4 yearly measurement time-points)
Changes in cognitive performance parameters - mathematics
mathematics via regular school tests
Measured: 3 years (4 yearly measurement time-points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start27 Sep 2021
- Primary completion1 Oct 2024
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Kristiania University College
- Responsible party
- Sponsor
- Investigators
- Nandu Goswami, Dr., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956003
- Sponsor's protocol ID
- HAPPY CHILDREN
- Status last verified
- Oct 2026
- First submitted
- 15 Jun 2021
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28454531Goswami 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.
PubMed 35722126
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Cardiometabolic Health, Cognition and Academic Performance With Happy Children (HAPHC) Using School-based Physical Activity
- ClinicalTrials.gov ID
- NCT04956003
- Acronym / sponsor ID
- HAPPY CHILDREN
- Conditions
- Physical Activity, Cardiometabolic Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Kristiania University College
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No intervention, but assessment of cardiometabolic health and cognition |
| Intervention Group | Experimental | Behavioral: 45-minute daily physical activityImplementing a daily 45-minute physical activity session as an integral part of learning. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- students in participating schools
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 45-minute daily physical activity45-minute daily physical activity session as an integral part of learning (during regular school sessions) | Behavioural | Intervention Group |
Primary outcome
Cardiovascular changes - heart rate
Time frame: 3 years (4 yearly measurement time-points)
heart rate
Cardiovascular changes - blood pressure
Time frame: 3 years (4 yearly measurement time-points)
blood pressure
Microcirculation
Time frame: 3 years (4 yearly measurement time-points)
retinal camera (retinal imaging)
Changes in subcutaneous adipose tissue
Time frame: 3 years (4 yearly measurement time-points)
Assessment via ultrasound
Changes in physical fitness - handgrip
Time frame: 3 years (4 yearly measurement time-points)
Strength via handgrip measurement
Changes in physical fitness - running
Time frame: 3 years (4 yearly measurement time-points)
Endurance via interval running test for 10 minutes
Changes in physical fitness - coordination
Time frame: 3 years (4 yearly measurement time-points)
coordination tested via Dordel-Koch-Test
Changes in cognitive performance parameters - concentration
Time frame: 3 years (4 yearly measurement time-points)
concentration tests
Changes in cognitive performance parameters - reading
Time frame: 3 years (4 yearly measurement time-points)
reading comprehension via regular school tests
Changes in cognitive performance parameters - mathematics
Time frame: 3 years (4 yearly measurement time-points)
mathematics via regular school tests
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 28454531Fredriksen 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.
- Derived from this study: PubMed 35722126Goswami 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nandu Goswami, Dr. principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 45-minute daily physical activity in people with Physical Activity and Cardiometabolic Health, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular changes - heart rate (time frame: 3 years (4 yearly measurement time-points)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04956003, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.