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

University of Massachusetts, Worcester

Status and phase: Completed; Phase 1

Conditions: Cardiovascular Disease

Treatments: Behavioral: EXCEL; Behavioral: Nutrition Education ONLY

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01104038

UMBCHB007

UL1RR025758-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Nutrition Education/Lifestyle Counseling

Active Comparator group

Description:

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.

Treatment:

Behavioral: Nutrition Education ONLY

EXCEL

Experimental group

Description:

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.

Treatment:

Behavioral: EXCEL

Behavioral: EXCEL