Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334113
Status:
COMPLETED
Last Update Posted:
2015-01-06
First Post:
2006-06-02
Brief Title:
Telerehabilitation Intervention to Promote Exercise for Diabetes
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Telerehabilitation Intervention to Promote Exercise for Diabetes
Status:
COMPLETED
Status Verified Date:
2014-12
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:
The overarching objective of this study is to develop an innovative strategy to address the problems of obesity and diabetes by promoting exercise adoption An automated telephone intervention will be developed that can be used to enhance exercise adoption over a twelve month period in a population of overweight or obese veterans with Type 2 diabetes
Detailed Description:
Approximately two thirds of American adults are overweight body mass index - BMI 25 and nearly one third of American adults are obese BMI 30 with veterans exhibiting even higher rates of being overweight and obese than those in the general population Obesity is a significant risk factor for a number of serious medical conditions including diabetes and is associated with high rates of morbidity and mortality Greater than 80 of individuals with diabetes are overweight or obese Sixteen million Americans have been diagnosed with diabetes and it has been speculated that this number will increase to 23 million by the year 2010 Furthermore there is a substantially higher prevalence of diabetes in the veteran population as compared to the general population with nearly 16 percent of veterans being affected This alarming increase has been associated with the increasing prevalence of obesity and sedentary lifestyles In a conference conducted by the National Institute of Diabetes and Digestive and Kidney Diseases in 1999 it was concluded that a major research initiative was needed to address the growing problem with physical inactivity and obesity because of the major impact these behaviors have on the development and treatment of diabetes
The benefits associated with exercise in the diabetic population are extensive and even though regular exercise is typically prescribed as a significant component of the diabetic treatment plan compliance tends to be very poor The overarching objective of this study is to adapt a low cost telephone intervention to be used to enhance exercise adoption in a population of overweight or obese veterans with type 2 diabetes The primary aim of this study is to implement and evaluate the effectiveness of this telehealth intervention over a six month period The secondary aim is to evaluate the impact this telehealth intervention has on weight and other diabetes relevant physical health parameters quality of life and psychological distress If the telehealth intervention is found to be efficacious the tertiary aim will be to evaluate the cost effectiveness of the intervention Over a 4-year period 140 overweight or obese veterans with type 2 diabetes will be recruited from the VA Boston Healthcare System All participants will be evaluated and provided with an exercise prescription for a home based walking program Participants will be randomized to either the Exercise Prescription condition alone or Exercise Prescription plus TLC-PED Telephone Linked Care - Promoting Exercise for Diabetes an automated telehealth intervention TLC-PED will use interactive voice response and recognition telephone technology to provide individualized phone messages for participants with diabetes It will be developed to incorporate theoretical principles that are known to enhance exercise adoption Specifically the intervention will use motivating principles based on the transtheoretical model of change Those in the TLC-PED condition will receive weekly automated telephone calls for a six month period It is hypothesized that overweight veterans with diabetes who receive the TLC-PED intervention versus those who do not during their six month participation in a home based walking program will be more likely to engage in regular physical activity and obtain improvements in self-reported physical activity and maintain these changes over a twelve month period
The benefits associated with exercise in the diabetic population are extensive and even though regular exercise is typically prescribed as a significant component of the diabetic treatment plan compliance tends to be very poor The overarching objective of this study is to adapt a low cost telephone intervention to be used to enhance exercise adoption in a population of overweight or obese veterans with type 2 diabetes The primary aim of this study is to implement and evaluate the effectiveness of this telehealth intervention over a six month period The secondary aim is to evaluate the impact this telehealth intervention has on weight and other diabetes relevant physical health parameters quality of life and psychological distress If the telehealth intervention is found to be efficacious the tertiary aim will be to evaluate the cost effectiveness of the intervention Over a 4-year period 140 overweight or obese veterans with type 2 diabetes will be recruited from the VA Boston Healthcare System All participants will be evaluated and provided with an exercise prescription for a home based walking program Participants will be randomized to either the Exercise Prescription condition alone or Exercise Prescription plus TLC-PED Telephone Linked Care - Promoting Exercise for Diabetes an automated telehealth intervention TLC-PED will use interactive voice response and recognition telephone technology to provide individualized phone messages for participants with diabetes It will be developed to incorporate theoretical principles that are known to enhance exercise adoption Specifically the intervention will use motivating principles based on the transtheoretical model of change Those in the TLC-PED condition will receive weekly automated telephone calls for a six month period It is hypothesized that overweight veterans with diabetes who receive the TLC-PED intervention versus those who do not during their six month participation in a home based walking program will be more likely to engage in regular physical activity and obtain improvements in self-reported physical activity and maintain these changes over a twelve month period
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