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Examining the Relationship Between Tobacco Exposure, Abdominal Obesity, and Metabolic Syndrome in Adolescents (The STRONG Kids Study) (STRONG Kids)

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ClinicalTrials.gov Identifier: NCT00808158
Recruitment Status : Completed
First Posted : December 15, 2008
Last Update Posted : November 30, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Metabolic Syndrome

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.

Study Design

Study Type : Observational
Actual Enrollment : 117 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metabolic Syndrome in Adolescents: Contribution of Tobacco and Central Fat
Study Start Date : October 2008
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Children ages 9 to 10 years old, with a body mass index (BMI) in the 50th to 98th percentile range

Outcome Measures

Primary Outcome Measures :
  1. Baseline association between tobacco exposure, abdominal obesity, adiponectin, and metabolic syndrome components [ Time Frame: Measured at baseline ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
Serum, whole blood, white blood cells, saliva, urine

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
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)

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

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): NCT00808158

United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Stephen R. Cook, MD, MPH University of Rochester
More Information

Responsible Party: Stephen Cook, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00808158     History of Changes
Other Study ID Numbers: 612
R01HL083056-01 ( U.S. NIH Grant/Contract )
First Posted: December 15, 2008    Key Record Dates
Last Update Posted: November 30, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases