Vascular Health and Exercise Performance of Overweight Children

Not Applicable

Completed

• Conditions: Patient Compliance

• Registration Number: NCT01729273
• Lead Sponsor: Stanford University

Brief Summary

The purpose of this study is to assess exercise performance in 20 healthy children 10-19 years of age with a body mass index greater than 85th percentile and to evaluate the effect of dietary and exercise intervention over 12 weeks.

Detailed Description

Our hypothesis is that the vascular health in these children will improve at the end of intervention. The results of this study will help us in our long-term objective of improving vascular health of children with congenital/acquired heart disease, a group particularly at risk for premature atherosclerosis.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-11-13
• Study First Submitted QC: 2012-11-13
• Study First Posted: 2012-11-20
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-02
• Last Update Posted: 2014-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 10-19 years old
• Overweight (BMI > 85 percentile)
• Interested in a 12 week ¬home exercise & nutrition program
• Have computer & internet access
• Can come to Lucile Packard Children's Hospital at Stanford for a 3-hour test at the start & end of the study (so only twice!)
• Are able to come to testing after fasting overnight
• Do not smoke
• Do not take any medications

Exclusion Criteria

• non-overweight adolescents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Vascular Health	Beginning of 12th week and end of 12th week	Tests will include: EndoPAT analysis to assess endothelial function, applanation tonometry to assess arterial stiffness, carotid artery imaging to assess the wall thickness of the carotid arteries, exercise testing to assess the physical exercise capacity of these children and blood work to evaluate the lipid profile and inflammation status (CRP). The participant will be asked to come in after an overnight fast. They will receive a snack bag before the exercise test.

Trial Locations

Locations (1)

Lucile Packard Children's Hospital at Stanford; 🇺🇸 Palo Alto, California, United States