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

This study has been completed.
Sponsor:
Collaborators:
Children's Hospital Boston
Information provided by (Responsible Party):
Laura Hayman, University of Massachusetts, Boston
ClinicalTrials.gov Identifier:
NCT01104038
First received: April 13, 2010
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Cardiovascular Disease
Behavioral: EXCEL
Behavioral: Nutrition Education ONLY
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: EXCEL: Change in Cardiometabolic Disease Risk Factors During an Interactive Fitness Program

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Boston:

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: April 2010
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Experimental: EXCEL
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.
Behavioral: EXCEL
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
Behavioral: 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

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Laura Hayman, Associate Vice-Provost for Research & Professor of Nursing, University of Massachusetts, Boston
ClinicalTrials.gov Identifier: NCT01104038     History of Changes
Other Study ID Numbers: UMBCHB007, UL1RR025758-02
Study First Received: April 13, 2010
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Boston:
physical activity
cardiometabolic risk
children

Additional relevant MeSH terms:
Cardiovascular Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014