EXCEL: Change in Cardiometabolic Disease Risk Factors During an Interactive Fitness Program
Information source: University of Massachusetts, Boston
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiovascular Disease
Intervention: EXCEL (Behavioral); EXCEL (Behavioral); Nutrition Education ONLY (Behavioral)
Phase: Phase 1
Status: Completed
Sponsored by: University of Massachusetts, Boston
Summary
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.
Clinical Details
Official title: EXCEL: Change in Cardiometabolic Disease Risk Factors During an Interactive Fitness Program
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: 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.
Secondary outcome: pre-post EXCEL intervention changes in cardiorespiratory fitness and cardiometabolic risk factors (blood lipids, blood pressure, body mass index [BMI], waist circumference)
Eligibility
Minimum age: 8 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- enrolled in grades 3-5
- able to attend GoKids and school-based weekly educational sessions for 12 weeks and
complete baseline and follow-up testing
- informed consent from a parent or legal guardian and written assent from the child
- English speaking child
- free from medical conditions that would prohibit exercise as indicated by permission
to participate in school physical education, and by review of screening questions
with clearance from primary care provider as necessary.
Exclusion Criteria:
- abnormalities on screening/baseline evaluation that could pose a significant risk for
exercise
- illness that would limit participation
- plans to move out of the area or change schools in the next 6 months
Locations and Contacts
Additional Information
GoKids Boston, an interdisciplinary research, training and community outreach facility, is main research site for EXCEL
Starting date: April 2010
Last updated: May 22, 2014
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