Clinical trial NCT00334113: Telerehabilitation Intervention to Promote Exercise for Diabetes
Official title: Telerehabilitation Intervention to Promote Exercise for Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Keywords: Diabetes Mellitus
Exercise
Obesity
Telemedicine
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-06-06
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 7-Day Physical Activity Recall (PAR)
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Medical Center, Jamaica Plain Campus
state: Massachusetts
Study officials:
affiliation: VA Medical Center, Jamaica Plain Campus
name: Deanna L Mori, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seligowski AV, Pless Kaiser AP, Niles BL, Mori DL, King LA, King DW. Sleep quality as a potential mediator between psychological distress and diabetes quality of life in veterans with type 2 diabetes. J Clin Psychol. 2013 Oct;69(10):1121-31. doi: 10.1002/jclp.21866. Epub 2012 May 25.