Clinical trial NCT01080339: Substudy of Change in Cardiometabolic Disease (CMD) Risk Factors During an Interactive Fitness Program
Official title: Change in Cardiometabolic Risk Factors During an Interactive Fitness Program: An Exploratory Sub-study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Insulin Resistance
Keywords: insulin resistance
cardiovascular risk
physical activity
child
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
First posted: 2010-03-04
Enrollment: 3
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children attending 3rd-5th grades at select Boston Public Schools will be eligible for participation.

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.

Eligibility criteria: Inclusion Criteria:

* Participation in main intervention study

Exclusion Criteria:

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

Primary outcomes:
measure: Insulin sensitivity (HOMA-IR)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Sarah D de Ferranti, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: de 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.