PACE-iDP: An Intervention for Youth at Risk for Diabetes
Condition: Obesity; Overweight; Diabetes
MeSH terms: Diabetes Mellitus; Overweight
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Cell Phone; Weekly access to interactive web site; Group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention of Type 2 Diabetes; Adolescents; Obesity; Overweight; Internet Technology; Cell Phone