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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Insulin Resistance

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participation in main intervention study Exclusion Criteria: Unwillingness to comply with study requirements including two visits and data collection procedures

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Physical Activity and Nutrition<br>Supervised physical activity in the form of novel gaming and exercise equipment several times per week for 12 weeks will be provided in addition to weekly nutrition education sessions. | |
| Nutrition Education Only<br>Children in this group will receive weekly group nutrition sessions, identical to those provided for the Physical Activity + Nutrition group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin resistance, cardiovascular risk, physical activity, child