STEP: Enhanced Physical Activity in Children and Youth With Epilepsy
Hypothesis: The investigators hypothesize that a pedometer-based motivated 6-months walking program will result in sustainable enhanced PA.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (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|
- Quality of Life (CHEQOL-25) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
No Intervention: Control Group
Sedentary children with epilepsy will maintain step count for 6 months and then be asked to increase the step count.
Experimental: Experimental Group
Sedentary Children with epilepsy, increase the step count weekly with phon-based motivational coaching strategies for 6 months and then check sustainability without further motivational support for another 6 months.
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 get feedback about performance toward goals
Enhanced PA will in turn positively influence health, social participation and QoL of sedentary CWE through multiple pathways. These will involve biomedical factors (i.e. attention deficit, depression, anxiety and sleep disorders); and contextual environmental and personal factors that include psychosocial factors at the child, family and community level (Figure 1).21 These factors may include family stressors, social support, self-efficacy, and autonomy.22 We expect that enhanced, sustained PA will improve health, functioning and QoL of CWE through its potential neuroprotective and circadian rhythm regulatory effects, and by increasing social participation, promoting a positive outlook on life and self-image, decreasing worries and concerns, decreasing emotional problems and the concealment of epilepsy, and delaying secondary health complications.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01550874
|Contact: Gabriel M Ronen, MD||905-521-2100 ext email@example.com|
|Contact: Sarah L Mitchell||905-521-2100 ext firstname.lastname@example.org|
|McMaster Children's Hospital||Recruiting|
|Hamilton, Ontario, Canada, L8S 4K1|
|Contact: Gabriel M Ronen, MD 905-521-2100 ext 73392 email@example.com|
|Contact: Helena Viveiros firstname.lastname@example.org|
|Principal Investigator: Ronen M. Ronen, MD|
|Sub-Investigator: Brian Timmons, PHD|
|Sub-Investigator: David Streiner, PHD|
|Sub-Investigator: Steven Bray, PHD|
|Sub-Investigator: Peter Rosenbaum, MD|
|Children's Hospital of Eastern Ontario||Active, not recruiting|
|Ottawa, Ontario, Canada, K1H 8L1|
|Principal Investigator:||Gabriel M Ronen, MD||McMaster University|