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Sponsored by: |
University of California, San Diego |
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Information provided by: | University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT00412165 |
This randomized control study (sponsored by the NIH, NIDDK) is aimed at reducing BMI in overweight adolescents at risk for the development of type 2 diabetes. The study will examine whether an integrated primary care, web and cell-phone-based intervention can produce initial and sustained improvements in anthropometric, behavioral, metabolic, and physiological outcomes in overweight adolescents. The primary goal is to reduce BMI (Body Mass Index)in overweight adolescents.
Condition | Intervention |
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Obesity Overweight Diabetes |
Behavioral: Weight Management Classes Behavioral: Cell Phone Behavioral: Weekly access to interactive web site Behavioral: Group Sessions with study participants Behavioral: Weekly Case Management via phone, mail, e-mail |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | PACE-iDP: An Intervention for Youth at Risk for Diabetes |
Estimated Enrollment: | 140 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | July 2008 |
Type 2 Diabetes Mellitus (DM) is a common disease that plagues over 16 million adults in the United States (American Diabetes Association [ADA], 2002). Over the past decade, the number of adults diagnosed with diabetes has risen dramatically. The high rates of type 2 diabetes have been associated with the simultaneously rapid increase in the prevalence of obesity, and diminished levels of physical activity in the population (Wing, 2001).
Type 2 diabetes is increasing in children and adolescents in the U.S. and worldwide (ADA, 2000). Several studies have demonstrated higher risk of type 2 diabetes in African-American, Hispanic, and American Indian children and adolescents (Glaser, 1997; Dean, 1992; Pinhas-Hamiel, 1996; Rosenbloom, 1999). Other characteristics, or risk factors, that may be used to identify children at high-risk for developing type 2 diabetes include obesity, family history, and physiologic manifestations of insulin resistance (ADA, 2000). Up to 85% of children with type 2 diabetes are overweight or obese at diagnosis. A majority of children with type 2 diabetes have at least one parent or first-degree relative with type 2 diabetes. Physiologic findings of insulin resistance that are present in large percentages of children with type 2 diabetes include acanthosis nigricans, polycystic ovarian syndrome, hypertension and lipid disorders (ADA, 2000). Among US children, the mean age at diagnosis of type 2 diabetes is between 12 and 14 years (Moran, 1999; Goran MI, 2001).
Obesity is commonly found in children with type 2 diabetes, and the increasing incidence of children with type 2 diabetes has been attributed to the growing problem of pediatric overweight and obesity (Fagot-Camapagna, et.al, 2000). It is often hypothesized that an industrialized, or “Westernized” lifestyle of excessive energy intake and sedentary behavior partially explains the recent emergence of type 2 diabetes and obesity in youth (Hill & Peters, 1998; Koplan & Dietz, 2000). Evidence that the number of years being obese is positively correlated with diabetes risk (Everhart, 1992), supports intervening in adolescence to minimize the number of years of obesity.
Obesity and physical inactivity are thought to be the main modifiable determinants of this disease, and interventions targeting diet and physical activity have been surprisingly effective in preventing diabetes in high-risk adults (Tuomilehto, 2001; NIDDK, 2001). There are no published studies that examine the efficacy of similar lifestyle interventions aimed at children and adolescents. Our rationale for intervening on these behaviors with high-risk adolescents is based on these findings, as well as the following: (a) the majority of adolescents do not meet current guidelines for physical activity and nutrition and (b) there is a steep age-related decline in physical activity that peaks in the teen years. In its March 2000 Consensus Statement of Type 2 Diabetes In Children and Adolescents, the ADA expert panel stated that, “Primary care providers have an obligation to encourage lifestyle modifications that might delay or prevent the onset of type 2 diabetes in children at high risk. Lifestyle interventions focusing on weight management and increasing physical activity should be promoted in all children at high risk for the development of type 2 diabetes." (ADA, 2000).
Ages Eligible for Study: | 12 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Criteria for participation in the study include:
Adolescent subjects must also have at least two of the following risk factors:
Exclusion Criteria:
Subjects will be excluded from participation if they have any of the following conditions:
Contact: Jill Rybar, MPH | 858-457-7280 | jrybar@ucsd.edu |
Contact: Isabella Parkinson, MA | 858-457-7280 | ibryantp@ucsd.edu |
United States, California | |
UCSD - La Jolla Professional Building | Recruiting |
La Jolla, California, United States, 92037 | |
Contact: Jill Rybar, MPH 858-457-7280 jrybar@ucsd.edu | |
Contact: Isabella Parkinson, MA 858-457-7280 ibryantp@ucsd.edu | |
Principal Investigator: Kevin Patrick, MD, MS |
Principal Investigator: | Kevin Patrick, MD, MS | UCSD |
Study ID Numbers: | 5 R18 DK064321, UCSD#: 2006-4039 |
Study First Received: | December 13, 2006 |
Last Updated: | December 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00412165 |
Health Authority: | United States: Institutional Review Board |
Prevention of Type 2 Diabetes Adolescents Obesity |
Overweight Internet Technology Cell Phone |
Obesity Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Overweight Body Weight Signs and Symptoms |
Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |