Vascular Health and Exercise Performance of Overweight Children - Clinical Trial for Patient Compliance | NCT01729273

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Diet and Exercise Intervention

About this trial

This is an interventional prevention trial for Patient Compliance

Eligibility Criteria

10 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Lucile Packard Children's Hospital at Stanford

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diet and Exercise Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01729273

First Posted

November 13, 2012

Last Updated

October 2, 2014

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT01729273

Brief Title

Vascular Health and Exercise Performance of Overweight Children

Acronym

VHEPOC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stanford University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patient Compliance

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diet and Exercise Intervention

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Diet and Exercise Intervention

Intervention Description

Remote Dietary and Exercise Intervention Program

Primary Outcome Measure Information:

Title

Vascular Health

Description

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.

Time Frame

Beginning of 12th week and end of 12th week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: