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Vascular Health and Exercise Performance of Overweight Children (VHEPOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01729273
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Patient Compliance Other: Diet and Exercise Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Vascular Health and Exercise Performance of Overweight Children in 12 Weeks Using Skype
Study Start Date : July 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Vascular Health [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729273


Locations
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United States, California
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94306
Sponsors and Collaborators
Stanford University
Investigators
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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
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01729273    
Other Study ID Numbers: CHRI-23724
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: October 6, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Overweight
Body Weight