EXCEL: Change in Cardiometabolic Disease Risk Factors During an Interactive Fitness Program (EXCEL)
|ClinicalTrials.gov Identifier: NCT01104038|
Recruitment Status : Completed
First Posted : April 15, 2010
Last Update Posted : May 26, 2014
University of Massachusetts, Boston
National Center for Research Resources (NCRR)
Boston Children’s Hospital
Information provided by (Responsible Party):
Laura Hayman, University of Massachusetts, Boston
Childhood obesity has increased in prevalence over the past several decades and is predictive of adult type 2 diabetes and cardiovascular disease (CVD). Recent studies of children and youth suggest that exercise reduces cardiometabolic risk factors. Minimal data are available, however, on the effects of "exergaming" , interactive technology- mediated approaches to increasing physical activity in children and youth. This project involves a partnership between UMass Boston/GoKids Boston and Children's Hospital Boston featuring an interdisciplinary team of researchers and clinicians from pediatric cardiology, nursing, prevention and behavioral sciences and exercise physiology and is designed to examine the effects of exergaming on moderate or vigorous physical activity (MVPA) indices of adiposity, risk factors for cardiometabolic disease and self-competence in Boston Public School children. It is hypothesized that participation in the EXCEL/exergaming intervention for 60 minutes, three times per week for 12 weeks will significantly increase MVPA (as measured by accelerometers), pre- to- post intervention and compared to an Advice only (Nutrition Education) group.Results of this pilot study will guide and inform a larger study of exergaming in children from the Boston Public Schools.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease||Behavioral: EXCEL Behavioral: Nutrition Education ONLY||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||EXCEL: Change in Cardiometabolic Disease Risk Factors During an Interactive Fitness Program|
|Study Start Date :||April 2010|
|Primary Completion Date :||June 2013|
|Study Completion Date :||July 2013|
Active Comparator: Nutrition Education/Lifestyle Counseling
Children in this group will receive weekly group nutrition sessions , 30 minutes per week for 12 weeks, identical to those provided for the EXCEL intervention group and delivered by a registered dietician.
Behavioral: Nutrition Education ONLY
Children in the nutrition education group will receive 30 minutes per week of group nutrition education in the school environment and delivered by a registered dietitian The nutrition education sessions will be identical to those provided for the EXCEL group.
The EXCEL arm is the experimental arm of the study. Participants in this arm will receive supervised physical activity in the form of novel gaming (technology-mediated physical activity, 60 minutes per session, three times per week , for 12 weeks and 12 weeks of group nutrition education sessions.
Children in the EXCEL intervention will receive 12 weeks of supervised physical activity, guided by principles of behavior change, in the form of exergaming (technology-mediated interactive physical activity)3 times per week for 12 weeks and will also receive weekly group nutrition education sessionsBehavioral: EXCEL
Participants in the EXCEL intervention will receive 12 weeks of supervised physical activity in the form of exergaming (technology-mediated physical activity). Sessions will be held 3 times per week with 60 minutes of supervised physical activity.
Other Name: EXERGAMING
Primary Outcome Measures :
- change in moderate or vigorous physical activity (MVPA) between baseline and final visit (12 weeks) in children in the Excel intervention group as compared to children in the Advice only (Nutrition Education) group. [ Time Frame: 12 weeks; follow up at 18 weeks ]The primary test of hypothesis is the comparison of change in MVPA between baseline and final visit (12 weeks) in children in the Excel intervention group as compared to children in the Advice-only (Nutrition Education) group. Accelerometers will be used to measure MVPA.
Secondary Outcome Measures :
- pre-post EXCEL intervention changes in cardiorespiratory fitness and cardiometabolic risk factors (blood lipids, blood pressure, body mass index [BMI], waist circumference) [ Time Frame: 12 weeks; follow-up at 18 weeks ]Cardiorespiratory fitness and cardiometabolic risk factors will be assessed at baseline and 12 and 18 weeks post-intervention in EXCEL intervention group and in the Advice only (Nutrition Education) group. Between and within group changes in cardiorespiratory fitness and cardiometabolic risk factors will be examined and compared at the 12 week and 18 week data point.
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