Vascular Health and Exercise Performance of Overweight Children

NCT ID: NCT01729273

Last Updated: 2014-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Patient Compliance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Diet and Exercise Intervention

Intervention Type OTHER

Remote Dietary and Exercise Intervention Program

Interventions

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Diet and Exercise Intervention

Remote Dietary and Exercise Intervention Program

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seda Tierney, MD

Role: PRINCIPAL_INVESTIGATOR

Lucile Packard Children's Hospital - Pediatric Cardiology

Chau N Vu, BS

Role: STUDY_DIRECTOR

Lucile Packard Children's Hospital - Pediatric Cardiology

Katie Jo Buccola

Role: STUDY_CHAIR

Lucile Packard Children's Hospital - Pediatric Cardiology

Jeffrey Kazmucha

Role: STUDY_CHAIR

Lucile Packard Children's Hospital - Pediatric Cardiology

Laurie Steinberg

Role: STUDY_CHAIR

Stanford Prevention Research Center

Olga Ogareva

Role: STUDY_CHAIR

Lucile Packard Children's Hospital - Pediatric Cardiology

Inger Olson, MD

Role: STUDY_CHAIR

Lucile Packard Children's Hospital - Pediatric Cardiology

Chinyelu Nwobu, MD

Role: STUDY_CHAIR

Lucile Packard Children's Hospital - Pediatric Cardiology

Locations

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Lucile Packard Children's Hospital at Stanford

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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CHRI-23724

Identifier Type: -

Identifier Source: org_study_id

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