Vascular Health and Exercise Performance of Overweight Children

Patient Compliance Clinical Trial

— VHEPOC  

Official title:

Vascular Health and Exercise Performance of Overweight Children in 12 Weeks Using Skype

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01729273
• Other study ID #: CHRI-23724
• Status: Completed
• Phase: N/A
• First received: November 13, 2012
• Last updated: October 2, 2014
• Start date: July 2012
• Est. completion date: March 2014

Study information

• Verified date: October 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 19 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Patient Compliance

Intervention

Other:
• Diet and Exercise Intervention
Remote Dietary and Exercise Intervention Program

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital at Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular Health	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.	Beginning of 12th week and end of 12th week	No