Study Stopped
Unable to recruit participants.
Substudy of Change in Cardiometabolic Disease (CMD) Risk Factors During an Interactive Fitness Program
EXCEL
Change in Cardiometabolic Risk Factors During an Interactive Fitness Program: An Exploratory Sub-study
1 other identifier
observational
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 3, 2010
CompletedFirst Posted
Study publicly available on registry
March 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedJune 23, 2011
June 1, 2011
1 year
March 3, 2010
June 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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
Eligibility Criteria
Children attending 3rd-5th grades at select Boston Public Schools will be eligible for participation.
You may qualify if:
- Participation in main intervention study
You may not qualify if:
- Unwillingness to comply with study requirements including two visits and data collection procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Children's Hospitallead
- University of Massachusetts, Worcestercollaborator
Study Sites (1)
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
Related Publications (2)
Levenson AE, Milliren CE, Biddinger SB, Ebbeling CB, Feldman HA, Ludwig DS, de Ferranti SD. Calorically restricted diets decrease PCSK9 in overweight adolescents. Nutr Metab Cardiovasc Dis. 2017 Apr;27(4):342-349. doi: 10.1016/j.numecd.2016.12.010. Epub 2017 Jan 3.
PMID: 28228332DERIVEDde Ferranti SD, Milliren CE, Denhoff ER, Quinn N, Osganian SK, Feldman HA, Ebbeling CB, Ludwig DS. Providing food to treat adolescents at risk for cardiovascular disease. Obesity (Silver Spring). 2015 Oct;23(10):2109-17. doi: 10.1002/oby.21246. Epub 2015 Sep 4.
PMID: 26337820DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah D de Ferranti, MD MPH
Boston Children's Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 3, 2010
First Posted
March 4, 2010
Study Start
February 1, 2010
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
June 23, 2011
Record last verified: 2011-06