Vascular Health and Exercise Performance of Overweight Children (VHEPOC)

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

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.

Study Overview

• Status: Completed
• Conditions: Patient Compliance
• Intervention / Treatment: Other: Diet and Exercise Intervention

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94306
      • Lucile Packard Children's Hospital at Stanford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 19 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Diet and Exercise Intervention; 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 Home Exercise Program will be 3 days a week for 12 weeks and participants will connect with the trainer to perform 45-60 minutes of a combination of strength training and aerobic activity via Skype. The Dietary Approaches to Stop Hypertension(DASH) eating pattern will be prescribed to all participants in the treatment group and specific strategies to achieve goals will be discussed weekly by the participant over the phone.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Seda Tierney, MD, Lucile Packard Children's Hospital - Pediatric Cardiology; Study Director: Chau N Vu, BS, Lucile Packard Children's Hospital - Pediatric Cardiology; Study Chair: Katie Jo Buccola, Lucile Packard Children's Hospital - Pediatric Cardiology; Study Chair: Jeffrey Kazmucha, Lucile Packard Children's Hospital - Pediatric Cardiology; Study Chair: Laurie Steinberg, Stanford Prevention Research Center; Study Chair: Olga Ogareva, Lucile Packard Children's Hospital - Pediatric Cardiology; Study Chair: Inger Olson, MD, Lucile Packard Children's Hospital - Pediatric Cardiology; Study Chair: Chinyelu Nwobu, MD, Lucile Packard Children's Hospital - Pediatric Cardiology

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: November 13, 2012
• First Submitted That Met QC Criteria: November 13, 2012
• First Posted (ESTIMATE): November 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 6, 2014
• Last Update Submitted That Met QC Criteria: October 2, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: CHRI-23724