Physical ActivityFeetEnergyNCT01633918
FeetEnergy Approach to Increase Physical Activity and Reduce Screen Time in Adolescents
A study testing Internet-supported FeetEnergy approach and Usual health education in people with Physical Activity and Sedentary Behavior, run by UKK Institute at 2 sites in Finland.
Trial summary
The purpose of this study is to find out whether an Internet-supported FeetEnergy approach and two home works integrated in three health education lessons can increase adolescents' active commuting to school and leisure-time physical activity and decrease their screen time. Read more about this study
- Who is it for?
- Ages 13 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Sedentary Behavior, Active Commuting
- What is being tested?
- Internet-supported FeetEnergy approach and Usual health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,291 participants
- Where
- 2 sitesFinland
- Study dates
- Aug 2012to May 2013
- 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 13 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- student's informed consent and an approval from his/her parent
Who cannot join
- no informed consent from the student and no approval from his/her parent
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Aalto University
Espoo, Aalto, 00076
The UKK Institute for health Promotion Research
Tampere, 33501
About this study
Official title: Integrating Internet-supported FeetEnergy Approach in Health Education Lessons to Increase Physical Activity and Reduce Screen Time in Adolescents
The purpose of this study is to find out whether an Internet-supported FeetEnergy approach and two home works integrated in three health education lessons can increase adolescents' active commuting to school and leisure-time physical activity and decrease their screen time.
- Conditions
- Physical Activity, Sedentary Behavior, Active Commuting, Psychosocial Factors, Parental Interference
- Being tested
- Internet-supported FeetEnergy approach, Usual health education
- Keywords
- intervention, health education, physical activity, sedentary behavior, health promotion, evaluation, RE-AIM
- Medical subject headings
- Motor Activity, Sedentary Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-supported FeetEnergy approachBehavioural
Three health education lessons and two homework's about increasing physical activity and reducing screen time
Usual health educationBehavioural
Usual health education lessons
| Study group | Role | What they receive |
|---|---|---|
| Internet-supported FeetEnergy approach | Experimental | Schools which integrate Internet-supported approach with two home works in three health education lessons on physical activity Receives: Behavioral: Internet-supported FeetEnergy approach |
| Usual health education | Active comparator | Schools which follow their usual practices in carrying out health education classes on physical activity Receives: Behavioral: Usual health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in meeting physical activity recommendation at 1 month
Measured: baseline and 1 month
change from baseline in physical activity recommendation at 7 months
Measured: baseline and 7 months
change from baseline in meeting screen time recommendation at 1 month
Measured: baseline and 1 month
change from baseline in meeting screen time recommendation at 7 month
Measured: baseline and 7 month
Secondary outcomes (4)
change from baseline in psychosocial factors related to physical activity at 1 month
Measured: baseline and 1 month
change from baseline in parental interference with physical activity of their child at 1 month
Measured: baseline and 1 month
change from baseline in psychosocial factors related to screen time at 1 month
Measured: baseline and 1 month
change from baseline in parental interference with screen time of their child at 1 month
Measured: baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2013
- Study completionMay 2013
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.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,291 participants (actual)
Sponsor and investigators
- Lead sponsor
- UKK Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education and Culture, Finland
- Responsible party
- Principal investigator, Minna Aittasalo, UKK Institute
- Investigators
- Minna M Aittasalo, Dsc, Principal investigator, UKK Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633918
- Sponsor's protocol ID
- 166,02
- Acronym
- FeetEnergy
- Status last verified
- Aug 2014
- First submitted
- 27 Jun 2012
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Aittasalo M, Jussila AM, Tokola K, Sievanen H, Vaha-Ypya H, Vasankari T. Kids Out; evaluation of a brief multimodal cluster randomized intervention integrated in health education lessons to increase physical activity and reduce sedentary behavior among eighth graders. BMC Public Health. 2019 Apr 17;19(1):415. doi: 10.1186/s12889-019-6737-x.
PubMed 30995905Jussila AM, Vasankari T, Paronen O, Sievanen H, Tokola K, Vaha-Ypya H, Broberg A, Aittasalo M. KIDS OUT! Protocol of a brief school-based intervention to promote physical activity and to reduce screen time in a sub-cohort of Finnish eighth graders. BMC Public Health. 2015 Jul 10;15:634. doi: 10.1186/s12889-015-2007-8.
PubMed 26160058
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Internet-supported FeetEnergy Approach in Health Education Lessons to Increase Physical Activity and Reduce Screen Time in Adolescents
- ClinicalTrials.gov ID
- NCT01633918
- Acronym / sponsor ID
- FeetEnergy / 166,02
- Conditions
- Physical Activity, Sedentary Behavior, Active Commuting, Psychosocial Factors, Parental Interference
- Keywords
- intervention, health education, physical activity, sedentary behavior, health promotion, evaluation, RE-AIM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,291 participants (actual)
- Lead sponsor
- UKK InstituteUniversity, hospital or other
- Collaborators
- Ministry of Education and Culture, Finland
- Study start
- Aug 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 Jul 2012 (estimated)
- 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.
The purpose of this study is to find out whether an Internet-supported FeetEnergy approach and two home works integrated in three health education lessons can increase adolescents' active commuting to school and leisure-time physical activity and decrease their screen time.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-supported FeetEnergy approach | Experimental | Behavioral: Internet-supported FeetEnergy approachSchools which integrate Internet-supported approach with two home works in three health education lessons on physical activity |
| Usual health education | Active comparator | Behavioral: Usual health educationSchools which follow their usual practices in carrying out health education classes on physical activity |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- student's informed consent and an approval from his/her parent
Key exclusion criteria (1 listed)
- no informed consent from the student and no approval from his/her parent
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 |
|---|---|---|
| Internet-supported FeetEnergy approachThree health education lessons and two homework's about increasing physical activity and reducing screen time | Behavioural | Internet-supported FeetEnergy approach |
| Usual health educationUsual health education lessons | Behavioural | Usual health education |
Primary outcome
change from baseline in meeting physical activity recommendation at 1 month
Time frame: baseline and 1 month
change from baseline in physical activity recommendation at 7 months
Time frame: baseline and 7 months
change from baseline in meeting screen time recommendation at 1 month
Time frame: baseline and 1 month
change from baseline in meeting screen time recommendation at 7 month
Time frame: baseline and 7 month
4 secondary outcomes
change from baseline in psychosocial factors related to physical activity at 1 month
Time frame: baseline and 1 month
change from baseline in parental interference with physical activity of their child at 1 month
Time frame: baseline and 1 month
change from baseline in psychosocial factors related to screen time at 1 month
Time frame: baseline and 1 month
change from baseline in parental interference with screen time of their child at 1 month
Time frame: baseline and 1 month
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 8 Dec 2015.
- Derived from this study: PubMed 30995905Aittasalo M, Jussila AM, Tokola K, Sievanen H, Vaha-Ypya H, Vasankari T. Kids Out; evaluation of a brief multimodal cluster randomized intervention integrated in health education lessons to increase physical activity and reduce sedentary behavior among eighth graders. BMC Public Health. 2019 Apr 17;19(1):415. doi: 10.1186/s12889-019-6737-x.
- Derived from this study: PubMed 26160058Jussila AM, Vasankari T, Paronen O, Sievanen H, Tokola K, Vaha-Ypya H, Broberg A, Aittasalo M. KIDS OUT! Protocol of a brief school-based intervention to promote physical activity and to reduce screen time in a sub-cohort of Finnish eighth graders. BMC Public Health. 2015 Jul 10;15:634. doi: 10.1186/s12889-015-2007-8.
- Related InfoLink provided by the sponsor.
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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.
Minna M Aittasalo, Dsc principal investigator
UKK Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-supported FeetEnergy approach and Usual health education in people with Physical Activity and Sedentary Behavior, run by UKK Institute at 2 sites in Finland.
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 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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?
change from baseline in meeting physical activity recommendation at 1 month (time frame: baseline and 1 month). The study lists 4 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 NCT01633918, 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 8 Dec 2015.