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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01080339
Recruitment Status : Terminated (Unable to recruit participants.)
First Posted : March 4, 2010
Last Update Posted : June 23, 2011
University of Massachusetts, Worcester
Information provided by:
Boston Children’s Hospital

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.

Condition or disease
Insulin Resistance

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.

Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Change in Cardiometabolic Risk Factors During an Interactive Fitness Program: An Exploratory Sub-study
Study Start Date : February 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Physical Activity and Nutrition
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
Children in this group will receive weekly group nutrition sessions, identical to those provided for the Physical Activity + Nutrition group

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children attending 3rd-5th grades at select Boston Public Schools will be eligible for participation.

Inclusion Criteria:

  • Participation in main intervention study

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01080339

United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
University of Massachusetts, Worcester
Principal Investigator: Sarah D de Ferranti, MD MPH Boston Children’s Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sarah de Ferranti, MD, Children's Hospital Boston Identifier: NCT01080339     History of Changes
Other Study ID Numbers: 09-12-0611
First Posted: March 4, 2010    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011

Keywords provided by Boston Children’s Hospital:
insulin resistance
cardiovascular risk
physical activity

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases