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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephen Cook, University of Rochester
ClinicalTrials.gov Identifier:
NCT00808158
First received: December 12, 2008
Last updated: November 29, 2012
Last verified: November 2012
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metabolic Syndrome in Adolescents: Contribution of Tobacco and Central Fat

Resource links provided by NLM:


Further study details as provided by University of Rochester:

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

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


Enrollment: 117
Study Start Date: October 2008
Study Completion Date: May 2012
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808158

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Stephen R. Cook, MD, MPH University of Rochester
  More Information

No publications provided

Responsible Party: Stephen Cook, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00808158     History of Changes
Other Study ID Numbers: 612, R01HL083056-01, HL086946-02
Study First Received: December 12, 2008
Last Updated: November 29, 2012
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 20, 2014