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

NCT01104038 | Completed Phase 1 DMC

• 2 other identifiers: UMBCHB007UL1RR025758-02
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Disease

Keywords

physical activity; cardiometabolic risk; children

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  12 weeks; follow up at 18 weeks

Secondary Outcomes (1)

• 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 weeks

Study Arms (2)

Nutrition Education/Lifestyle Counseling

ACTIVE COMPARATOR

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

EXCEL

EXPERIMENTAL

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

Interventions

EXCEL BEHAVIORAL

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

EXCEL

Nutrition Education ONLY BEHAVIORAL

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.

Nutrition Education/Lifestyle Counseling

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Boston: lead
• National Center for Research Resources (NCRR): collaborator
• Boston Children's Hospital: collaborator

Related Publications (1)

• 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.

  PMID: 26510013 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Vice-Provost for Research & Professor of Nursing

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 15, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 26, 2014

Record last verified: 2014-05