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

This study has been terminated.
(Unable to recruit participants.)
Sponsor:
Collaborator:
University of Massachusetts, Worcester
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01080339
First received: March 3, 2010
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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
Insulin Resistance

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Change in Cardiometabolic Risk Factors During an Interactive Fitness Program: An Exploratory Sub-study

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Insulin sensitivity (HOMA-IR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 3
Study Start Date: February 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • Participation in main intervention study

Exclusion Criteria:

  • Unwillingness to comply with study requirements including two visits and data collection procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080339

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

No publications provided

Responsible Party: Sarah de Ferranti, MD, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01080339     History of Changes
Other Study ID Numbers: 09-12-0611
Study First Received: March 3, 2010
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 23, 2014