Clinical trial NCT01104038: EXCEL: Change in Cardiometabolic Disease Risk Factors During an Interactive Fitness Program
Official title: EXCEL: Change in Cardiometabolic Disease Risk Factors During an Interactive Fitness Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Disease
Keywords: physical activity
cardiometabolic risk
children
Lead sponsor: University of Massachusetts, Boston
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
name: Boston Children's Hospital
First posted: 2010-04-15
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 12 weeks; follow up at 18 weeks
Secondary outcomes:
measure: pre-post EXCEL intervention changes in cardiorespiratory fitness and cardiometabolic risk factors (blood lipids, blood pressure, body mass index [BMI], waist circumference)
timeFrame: 12 weeks; follow-up at 18 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Crouter SE, de Ferranti SD, Whiteley J, Steltz SK, Osganian SK, Feldman HA, Hayman LL. Effect on Physical Activity of a Randomized Afterschool Intervention for Inner City Children in 3rd to 5th Grade. PLoS One. 2015 Oct 28;10(10):e0141584. doi: 10.1371/journal.pone.0141584. eCollection 2015.