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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01633918
Other study ID # 166,02
Secondary ID
Status Completed
Phase N/A
First received June 27, 2012
Last updated December 7, 2015
Start date August 2012
Est. completion date May 2013

Study information

Verified date August 2014
Source UKK Institute
Contact n/a
Is FDA regulated No
Health authority Finland: Data Protection BoardFinland: National Advisory Board on Health Care EthicsFinland: Ministry of Social Affairs and Health
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 1291
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 13 Years to 15 Years
Eligibility Inclusion Criteria:

- student's informed consent and an approval from his/her parent

Exclusion Criteria:

- no informed consent from the student and no approval from his/her parent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Intervention

Behavioral:
Internet-supported FeetEnergy approach
Three health education lessons and two homework's about increasing physical activity and reducing screen time
Usual health education
Usual health education lessons

Locations

Country Name City State
Finland Aalto University Espoo Aalto
Finland The UKK Institute for health Promotion Research Tampere

Sponsors (2)

Lead Sponsor Collaborator
UKK Institute Ministry of Education and Culture, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary change from baseline in meeting physical activity recommendation at 1 month baseline and 1 month Yes
Primary change from baseline in physical activity recommendation at 7 months baseline and 7 months Yes
Primary change from baseline in meeting screen time recommendation at 1 month baseline and 1 month Yes
Primary change from baseline in meeting screen time recommendation at 7 month baseline and 7 month Yes
Secondary change from baseline in psychosocial factors related to physical activity at 1 month baseline and 1 month Yes
Secondary change from baseline in parental interference with physical activity of their child at 1 month baseline and 1 month No
Secondary change from baseline in psychosocial factors related to screen time at 1 month baseline and 1 month Yes
Secondary change from baseline in parental interference with screen time of their child at 1 month baseline and 1 month No
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