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FeetEnergy Approach to Increase Physical Activity and Reduce Screen Time in Adolescents (FeetEnergy)

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ClinicalTrials.gov Identifier: NCT01633918
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : December 8, 2015
Sponsor:
Collaborator:
Ministry of Education and Culture, Finland
Information provided by (Responsible Party):
Minna Aittasalo, UKK Institute

Tracking Information
First Submitted Date  ICMJE June 27, 2012
First Posted Date  ICMJE July 4, 2012
Last Update Posted Date December 8, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2012)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01633918 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FeetEnergy Approach to Increase Physical Activity and Reduce Screen Time in Adolescents
Official Title  ICMJE Integrating Internet-supported FeetEnergy Approach in Health Education Lessons to Increase Physical Activity and Reduce Screen Time in Adolescents
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Physical Activity
  • Sedentary Behavior
  • Active Commuting
  • Psychosocial Factors
  • Parental Interference
Intervention  ICMJE
  • Behavioral: Internet-supported FeetEnergy approach
    Three health education lessons and two homework's about increasing physical activity and reducing screen time
  • Behavioral: Usual health education
    Usual health education lessons
Study Arms  ICMJE
  • Experimental: Internet-supported FeetEnergy approach
    Schools which integrate Internet-supported approach with two home works in three health education lessons on physical activity
    Intervention: Behavioral: Internet-supported FeetEnergy approach
  • Active Comparator: Usual health education
    Schools which follow their usual practices in carrying out health education classes on physical activity
    Intervention: Behavioral: Usual health education
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2013)
1291
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2012)
1000
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01633918
Other Study ID Numbers  ICMJE 166,02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Minna Aittasalo, UKK Institute
Study Sponsor  ICMJE UKK Institute
Collaborators  ICMJE Ministry of Education and Culture, Finland
Investigators  ICMJE
Principal Investigator: Minna M Aittasalo, Dsc UKK Institute
PRS Account UKK Institute
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP