Vascular Health and Exercise Performance of Overweight Children

NCT01729273 | Completed DMC

• 1 other identifier: CHRI-23724
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Compliance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Diet and Exercise Intervention

EXPERIMENTAL

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

Interventions

Diet and Exercise Intervention OTHER

Remote Dietary and Exercise Intervention Program

Diet and Exercise Intervention

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• non-overweight adolescents

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94306, United States

Location

MeSH Terms

Conditions

Patient Compliance

Interventions

Diet

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Seda Tierney, MD

  Lucile Packard Children's Hospital - Pediatric Cardiology

  PRINCIPAL INVESTIGATOR

• Chau N Vu, BS

  Lucile Packard Children's Hospital - Pediatric Cardiology

  STUDY DIRECTOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 20, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 6, 2014

Record last verified: 2014-10

Locations

US (1)