PACE-iDP: An Intervention for Youth at Risk for Diabetes
|ClinicalTrials.gov Identifier: NCT00412165|
Recruitment Status : Completed
First Posted : December 15, 2006
Last Update Posted : August 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Obesity Overweight Diabetes||Behavioral: Cell Phone Behavioral: Weekly access to interactive web site Behavioral: Group||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PACE-iDP: An Intervention for Youth at Risk for Diabetes|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||May 2009|
No Intervention: usual care
Usual care arm receives standard physical activity, nutrition and weight loss information from their primary care provider. The study offers and pays for a series of weight management sessions provided by Rady's Children's Hospital and Health Center's Nutrition Dept.
Experimental: Intervention - Web
This group receives access to a program internet site with weekly challenges aimed at weight loss through increased physical activity and nutrition.
Behavioral: Weekly access to interactive web site
This group receives access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail
Experimental: Intervention - Group
This group receives access to a program internet site with weekly challenges aimed at weight loss through increased physical activity and nutrition and has access to monthly group session with other teen and parent participants.
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
Experimental: Intervention - Cell Phone
This group receives access to a program internet site with weekly challenges aimed at weight loss through increased physical activity and nutrition and are provided with cell phones to use during the program. The cell phone allows for the transfer of text messages from the study to the participant that are tailored to their health goals. In addition, self-monitoring and uploading capabilities to the program website are included.
Behavioral: Cell Phone
The cell phone arm receives access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412165
|United States, California|
|UCSD - CALIT2- Atkinson Hall|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Kevin Patrick, MD, MS||UCSD|