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Telerehabilitation Intervention to Promote Exercise for Diabetes

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ClinicalTrials.gov Identifier: NCT00334113
Recruitment Status : Completed
First Posted : June 6, 2006
Results First Posted : November 27, 2014
Last Update Posted : January 6, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Obesity Behavioral: TLC-PED

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telerehabilitation Intervention to Promote Exercise for Diabetes
Study Start Date : January 2009
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1
Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will recieve an intervention that will be delivered over an automated telephone system (TLC-PED). These automated phone calls with voice response and voice recognition capabilities will occur weekly over a 6 month period. During these calls, participants' physical activity will be monitored, new physical activities goals will be set, information about physical activity and the associated health benefits will be provided, and barriers to physical activity will be explored.
Behavioral: TLC-PED
Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program.
No Intervention: Arm 2
This is the "treatment as usual" condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity.

Outcome Measures

Primary Outcome Measures :
  1. 7-Day Physical Activity Recall (PAR) [ Time Frame: six months ]
    A self-report measure of minutes of physical activity over the previous 7 days.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of type 2 diabetes mellitus
  • Receive a medical clearance from physician
  • Be sedentary
  • Be interested in exercising
  • Have a BMI > 25 kg/m2
  • Have an HbA1c between 7 & 10%
  • Be on medication for diabetes

Exclusion Criteria:

  • Significant peripheral neuropathy
  • Active psychosis
  • Psych admission or substance abuse in the last 6 months
  • Severe brain dysfunction
  • Abnormal ECG
  • Orthopedic related limitations
  • Unable to understand English
  • No direct access to telephone
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334113

United States, Massachusetts
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Deanna L Mori, PhD VA Medical Center, Jamaica Plain Campus
More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00334113     History of Changes
Other Study ID Numbers: F4202-I
First Posted: June 6, 2006    Key Record Dates
Results First Posted: November 27, 2014
Last Update Posted: January 6, 2015
Last Verified: December 2014

Keywords provided by VA Office of Research and Development:
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases