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EXCEL: Change in Cardiometabolic Disease Risk Factors During an Interactive Fitness Program

EXCEL: Change in Cardiometabolic Disease Risk Factors During an Interactive Fitness Program

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01104038
Acronym
EXCEL
Enrollment
60
Registered
2010-04-15
Start date
2010-04-30
Completion date
2013-07-31
Last updated
2014-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

physical activity, cardiometabolic risk, children

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.

Interventions

BEHAVIORALEXCEL

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 sessions

BEHAVIORALNutrition 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.

Sponsors

National Center for Research Resources (NCRR)
CollaboratorNIH
Boston Children's Hospital
CollaboratorOTHER
University of Massachusetts, Boston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.12 weeks; follow up at 18 weeksThe 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

MeasureTime frameDescription
pre-post EXCEL intervention changes in cardiorespiratory fitness and cardiometabolic risk factors (blood lipids, blood pressure, body mass index [BMI], waist circumference)12 weeks; follow-up at 18 weeksCardiorespiratory 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026