Diabetes Mellitus, Type 2, Obesity
Conditions
Keywords
Diabetes Mellitus, Exercise, Obesity, Telemedicine
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.
Interventions
BEHAVIORALTLC-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.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-Day Physical Activity Recall (PAR) | six months | A self-report measure of minutes of physical activity over the previous 7 days. |
Countries
United States
Participant flow
Pre-assignment details
Of the 89 participants were enrolled in this study, only 66 participants were randomized. Of the difference, 18 were determined to be ineligible (17 for medical reasons, 1 for other reasons), and 5 participants dropped out before randomization.
Participants by arm
| Arm | Count |
|---|---|
| TLC-PED Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
Motivate physical activity in diabetic individuals.: 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. | 32 |
| Treatment as Usual 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. | 34 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Treatment as Usual | TLC-PED |
|---|---|---|---|
| 7 Day Physical Activity Recall | 355 minutes of physical activity in a week STANDARD_DEVIATION 339 | 341 minutes of physical activity in a week STANDARD_DEVIATION 329 | 370 minutes of physical activity in a week STANDARD_DEVIATION 251 |
| Age, Continuous | 63 years STANDARD_DEVIATION 10 | 62 years STANDARD_DEVIATION 11 | 63 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 63 Participants | 32 Participants | 31 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 32 | 3 / 34 |
| serious Total, serious adverse events | 5 / 32 | 6 / 34 |
Outcome results
Primary
7-Day Physical Activity Recall (PAR)
A self-report measure of minutes of physical activity over the previous 7 days.
Time frame: six months
Population: Participants analyzed varies from completed participants since the completed number comes from those who stayed in the study through the 12 months (6 months post intervention). In TAU, the number who completed exceeds the number analyzed since 1 participant did not show for the 6 month assessment but did show for the 12 month follow up assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TLC-PED | 7-Day Physical Activity Recall (PAR) | 319 minutes per week | Standard Deviation 251 |
| Treatment as Usual | 7-Day Physical Activity Recall (PAR) | 360 minutes per week | Standard Deviation 329 |