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Clinical Trials/NCT01080339
NCT01080339
Terminated
N/A

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

Boston Children's Hospital1 site in 1 country3 target enrollmentFebruary 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Insulin Resistance
Sponsor
Boston Children's Hospital
Enrollment
3
Locations
1
Primary Endpoint
Insulin sensitivity (HOMA-IR)
Status
Terminated
Last Updated
14 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
February 2011
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Participation in main intervention study

Exclusion Criteria

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

Outcomes

Primary Outcomes

Insulin sensitivity (HOMA-IR)

Time Frame: 12 weeks

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.

Study Sites (1)

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