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.
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).
The cell phone arm receives access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail
This group receives access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail
The Group arm receives monthly face to face group sessions plus access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail
UCSD - CALIT2- Atkinson Hall
La Jolla, California, United States
To evaluate the effect, at 12 months, of the 3 intensities of the PACEi-DP intervention on Body Mass Index (BMI) among male & female adolescents.
Time frame: baseline, 6 mo, 12 mo
at 6 and 12 months,the impact of the PACEi-DP interventions on:metabolic and physiological manifestations of insulin resistance
Time frame: 6 mo, 12 mo
anthropometric measures including BMI at 6 months, waist to hip ratio at 6 and 12 months, percent body fat (DEXA) at 6 and 12 months,and
Time frame: 6 mo, 12 mo
behavioral measures of diet and physical activity.
Time frame: 6 mo, 12 mo
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
101