Substudy of Change in Cardiometabolic Disease (CMD) Risk Factors During an Interactive Fitness Program

Insulin Resistance Clinical Trial

— EXCEL  

Official title:

Change in Cardiometabolic Risk Factors During an Interactive Fitness Program: An Exploratory Sub-study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01080339
• Other study ID #: 09-12-0611
• Status: Terminated
• Phase: N/A
• First received: March 3, 2010
• Last updated: June 22, 2011
• Start date: February 2010
• Est. completion date: February 2011

Study information

• Verified date: June 2011
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Substudy examining cardiovascular and metabolic risk factor change in children at high risk for future atherosclerosis who are enrolled in a pilot intervention using novel gaming and exercise activities to increase physical activity.

Description:

Childhood obesity is increasingly common and is predictive of adult type 2 diabetes and cardiovascular disease (CVD). Recent pediatric studies suggest exercise reduces cardiometabolic risk factors. Despite evidence of its benefits, exercise training prescribed by pediatricians is traditionally vague, developmentally inappropriate, and/or fraught with psychological, financial and practical barriers. There has been recent interest in the use of interactive technologies, also termed "exer-gaming" as a way to translate known positive benefits of exercise into increased physical activity in youth. Initial adult studies demonstrate benefits, yet there are few studies of exer-gaming involving children at increased CVD risk. This project involves a partnership between Children's Hospital Boston and the GoKids Boston Youth Fitness Research and Training Center at UMass Boston, featuring an interdisciplinary team of researchers and clinicians from pediatric cardiology, prevention, nursing, exercise physiology, and behavior change. Participants are eligible for this substudy based on enrollment in a pilot project evaluating the effects of a state-of-the-art exercise training facility incorporating the latest technology-based exercise games ("exer-games") in Boston Public School elementary children. Effects on CVD risk factor levels including lipids, blood pressure, body composition vascular reactivity, insulin resistance pre and post intervention will be compared to an Advice-Only condition and correlated with activity level. Eligible participants will be identified as part of the baseline measurements of that study and will be offered the chance to participate in the CHB Sub-Study, a two visit observational design.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• Participation in main intervention study

Exclusion Criteria:

• Unwillingness to comply with study requirements including two visits and data collection procedures

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Insulin Resistance

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Boston	University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity (HOMA-IR)	Homeostasis model assessment of insulin resistance (HOMA-IR) will be measured at baseline and after 12 weeks of physical activity plus nutrition advice intevention, or nutrition-only advice.	12 weeks	No