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Examining the Relationship Between Tobacco Exposure, Abdominal Obesity, and Metabolic Syndrome in Adolescents (The STRONG Kids Study)
This study is currently recruiting participants.
Verified by National Heart, Lung, and Blood Institute (NHLBI), March 2009
First Received: December 12, 2008   Last Updated: March 26, 2009   History of Changes
Sponsors and Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
University of Rochester
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00808158
  Purpose

Metabolic syndrome is a term that describes a group of conditions that increase the risk of cardiovascular disease. The conditions include high blood pressure, obesity, and high cholesterol. This study will examine how changes in tobacco exposure and weight can affect the risk of developing metabolic syndrome among adolescents.


Condition
Metabolic Syndrome

MedlinePlus related topics: Obesity Obesity in Children
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Metabolic Syndrome in Adolescents: Contribution of Tobacco and Central Fat

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Baseline association between tobacco exposure, abdominal obesity, adiponectin, and metabolic syndrome components [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Temporal change in abdominal obesity, adiponectin, and metabolic syndrome components, as correlated with level of tobacco exposure [ Time Frame: Measured at Years 1, 2, and 3 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Serum, whole blood, white blood cells, saliva, urine


Estimated Enrollment: 240
Study Start Date: October 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Children ages 9 to 10 years old, with a body mass index (BMI) in the 50th to 98th percentile range

Detailed Description:

Metabolic syndrome is a term that is used to describe a group of risk factors for cardiovascular disease. The risk factors include obesity, insulin resistance, high cholesterol, and high blood pressure. Two of the most common risk factors for cardiovascular disease-tobacco exposure and abdominal obesity—are also known to influence the development of metabolic syndrome. Metabolic syndrome risk factors, as well as higher obesity levels, are being observed increasingly in adolescents. It is important to understand the relationship between tobacco exposure, abdominal obesity, and metabolic syndrome during early adolescence, as this time period is when lifestyle habits, including diet, exercise, and tobacco use, develop. The purpose of the study is to determine how changes in abdominal obesity and tobacco exposure among adolescents affect the development of metabolic syndrome risk factors, including glucose intolerance and increased levels of cholesterol and blood pressure.

This 3-year study will enroll children with a body mass index in the 50th to 98th percentile and one of their parents. At a baseline study visit, children and parents will complete questionnaires on health, nutrition, physical activity, smoke exposure, and stress levels. Children will undergo a blood and saliva collection; physical examination; measurements of blood pressure, height, weight, and waist circumference; a dual-energy x-ray absorptiometry (DEXA) scan to measure body fat and muscle; and skin fold measurements to measure body fat. Parents will undergo a saliva collection and measurements of blood pressure, height, weight, and waist circumference. Some children will wear an activity monitor for 7 days, and some children will complete a glucose tolerance test, which will involve an additional blood collection. Every 6 months, study researchers will contact parents to confirm the family's contact information. Once a year for 3 years, all participants will complete questionnaires and a saliva collection. Additionally, at Year 3, all participants will also undergo repeat measurements of blood pressure, height, weight, and waist circumference.

  Eligibility

Ages Eligible for Study:   9 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

A community sample of 240 9- to 10-year olds with varying abdominal obesity levels (all having a waist circumference equal to or above the 50th percentile for age and gender) and varying tobacco smoke exposure levels (from none to high levels)

Criteria

Inclusion Criteria:

  • BMI in the 50th to 98th percentile range
  • Parent or caregiver must agree to participate in the study

Exclusion Criteria for All Participants:

  • Inability to speak and understand English
  • Family residence outside the greater Rochester area (more than 50 miles from the clinical research center)
  • Family is planning to leave the greater Rochester area (move more than 50 miles from the clinical research center) in the 24 months after study entry

Exclusion Criteria for Children:

  • Significant medical condition, including cystic fibrosis, type 1 or type 2 diabetes, or other conditions that could interfere with the assessment of metabolic-related outcome measures
  • Tanner stage 3 or greater
  • Currently taking medications that alter appetite and/or glucose metabolism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808158

Contacts
Contact: Deborah Fredley, MS, RD 585-276-3104 deborah_fredley@urmc.rochester.edu
Contact: Stephen R. Cook, MD, MPH 585-275-9279 stephen_cook@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Deborah Fredley, MS, RD     585-276-4705     deborah_fredley@urmc.rochester.edu    
Contact: Stephen R. Cook, MD, MPH     585-275-9279     stephen_cook@urmc.rochester.edu    
Principal Investigator: Stephen R. Cook, MD, MPH            
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Stephen R. Cook, MD, MPH University of Rochester
  More Information

No publications provided

Responsible Party: University of Rochester ( Stephen R. Cook, MD, MPH, Assistant Professor of Pediatrics )
Study ID Numbers: 612, HL086946-02
Study First Received: December 12, 2008
Last Updated: March 26, 2009
ClinicalTrials.gov Identifier: NCT00808158     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Obesity

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on May 07, 2009