STEP: Enhanced Physical Activity in Children and Youth With Epilepsy (STEP)
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|ClinicalTrials.gov Identifier: NCT01550874|
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : June 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Behavioral: Physical activity behavior-change counselling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||STEP: Enhanced Physical Activity in Children and Youth With Epilepsy: Developing Evidence of Impacts on Health, Functioning, Psychological Wellbeing, and Quality of Life|
|Actual Study Start Date :||April 2, 2012|
|Actual Primary Completion Date :||March 31, 2018|
|Actual Study Completion Date :||March 31, 2018|
No Intervention: Control Group
Wear the pedometer provided by study everyday with weekly charging and syncing of data.
Experimental: Experimental Group
Wear the pedometer provided by the study everyday and also participate in phone-based physical activity behavior-change counselling for 6 months and then check sustainability without further motivational support for another 6 months.
Behavioral: Physical activity behavior-change counselling
Participants in the experimental group will be motivated by augmented behavior modification strategies aiming to increase performance by: (i) having access to the pedometer web page that allows them to view their automatically calculated goals, and (ii) get feedback about performance toward goals.
- CHEQOL-25 [ Time Frame: Baseline, 16 week follow-up, 28 week follow-up ]Measure of quality of life
- KIDSCREEN-27 [ Time Frame: Baseline, 16 week follow-up, 28 week follow-up ]Will look at Psychological Well-Being (7items) subscale
- Step Count [ Time Frame: Baseline, 16 week follow-up, 28 week follow-up ]Will use step counts obtained from pedometer
- KIDSCREEN-27 [ Time Frame: Baseline, 16 week follow-up, 28 week follow-up ]Will look at Physical Well-Being (5 items), Parents and Autonomy (7 items), Social Support and Peers (4 items) and School Environment (4 items) subscales
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550874
|McMaster Children's Hospital|
|Hamilton, Ontario, Canada, L8S 4K1|
|Children's Hospital of Eastern Ontario|
|Ottawa, Ontario, Canada, K1H 8L1|
|Principal Investigator:||Gabriel M Ronen, MD||McMaster University|