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

NCT ID: NCT01080339

Last Updated: 2011-06-23

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-02-28

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.

Conditions

Insulin Resistance

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Nutrition Education Only

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Participation in main intervention study

Exclusion Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Children's Hospital Boston

Principal Investigators

Sarah D de Ferranti, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Children's Hospital Boston

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28228332 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26337820 (View on PubMed)

Other Identifiers

09-12-0611

Identifier Type: -

Identifier Source: org_study_id