Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412165
Status:
COMPLETED
Last Update Posted:
2012-08-16
First Post:
2006-12-13
Brief Title:
PACE-iDP An Intervention for Youth at Risk for Diabetes
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
PACE-iDP An Intervention for Youth at Risk for Diabetes
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Indexin 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 US 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 etal 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
Type 2 diabetes is increasing in children and adolescents in the US 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 etal 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCSD 2006-4039 | None | None | None |