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| Sponsors and Collaborators: |
University of Pittsburgh U.S. Air Force Office of the Surgeon General |
|---|---|
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00867425 |
Purpose
The objective of this study is to evaluate the effectiveness of Virtual Lifestyle Management (VLM) as a behavior modification tool to promote weight loss, healthy eating and physical activity patterns, in the interest of reducing risk and adverse outcomes for individuals at high risk of type 2 diabetes (T2D) and cardiovascular disease (CVD) in a military population.
Specific Aim: To evaluate the effect of VLM on cardiovascular risk status in participants at high risk or individuals with T2D enrolled in the pilot study. The investigators hypothesize that participants will show greater improvement in weight as well as glucose, blood pressure, lipids, and self-reported diet and physical activity than will similar patients who are not enrolled in VLM.
| Condition | Intervention |
|---|---|
|
Obesity Diabetes Cardiovascular Disease |
Behavioral: Virtual Lifestyle Management |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | Translating the Diabetes Prevention Program Into a Virtual Lifestyle Management Program: A Pilot Study in a Military Community |
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2009 |
| Arms | Assigned Interventions |
|---|---|
| Intervention: Experimental |
Behavioral: Virtual Lifestyle Management
The VLM online lifestyle intervention will include elements of a behavioral lifestyle program developed by the Diabetes Prevention Program (1). VLM will assist individual participants with establishing appropriate weight loss goals, implementing dietary recommendations (including analysis of current diet), and defining exercise programs. Participants will be encouraged to complete 16 online, weekly lessons. The VLM curriculum provides standard information about healthy lifestyle, and behavioral techniques for integrating them into daily living. In each lesson, patients provide feedback about how they interpret the information, and ideas for integrating it into their lives. The VLM lifestyle coaching team will review these entries weekly, and provide support, feedback about progress, tips on how to problem-solve around lifestyle barriers, and guidance on how to use the "Keeping Track" functions of VLM (e.g. keeping track of weight, fat intake, calories or physical activity). |
As the epidemic of obesity continues to grow in both the United States and military populations, innovative lifestyle interventions that fit into the schedules of a busy population are critical. The rising costs of obesity (direct medical costs as well as societal costs) are staggering, and left unaddressed, they will overwhelm the budgets of many employers. Additionally, the costs in terms of military readiness are critical. As more career soldiers choose separation over weight reduction, the loss of institutional knowledge and intellectual capital are consequences that will continue to be felt. A program that is successful, scaleable, and transferable to remote locations could help stem this tide. VLM will begin the process of allowing the internet to be used not only as an informational and communication tool, but also as a means of accessing a comprehensive and well-validated lifestyle program from the internet-access point of greatest convenience.
Type 2 diabetes (T2D) affects 18 million Americans(2) and costs $132 billion in expenditures and lost productivity.(3) Treatment and prevention are essential, yet current recommendations,(4) combining medical care with self-care, are difficult to implement. Furthermore, strong evidence supports the use of comprehensive, intensive lifestyle interventions for obesity among primary care patients. While such programs may help reduce the risk of T2D onset, assist with glucose management among individuals who have T2D, and benefit other obesity-related health problems, such programs are commonly lacking in clinical practice.
This pilot study will test a model for the implementation of a VLM program that utilizes the internet to address good nutrition, safe weight loss methods and the importance of physical activity with the "virtual" support of a lifestyle coaching team to sustain participants in their weight loss and physical activity efforts. The focus of this initiative is to promote weight loss and healthy diet and exercise patterns, in the interest of preventing and treating T2D, and minimizing the risk of CVD in the military community. The study will be open to individuals who receive medical care through Wilford Hall Medical Center (WHMC) clinics.
Eligibility| Ages Eligible for Study: | 18 Years to 62 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Tina D Bhargava, MA | 412-692-4852 | bhargavat@upmc.edu |
| Contact: Kathleen M McTigue, MD, MS, MPH | mctiguekm@upmc.edu |
| United States, Texas | |
| Wilford Hall Medical Center | Recruiting |
| Lackland AFB, Texas, United States, 78236 | |
| Contact: Tina D Bhargava, MA 866-461-3218 bhargavat@upmc.edu | |
| Principal Investigator: Mark K Wallace, MD, USA, MC | |
| Study Director: | Kathleen M McTigue, MD, MS, MPH | University of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh ( Kathleen McTigue, MD, MS, MPH ) |
| Study ID Numbers: | PRO08030183, FWH20080195H |
| Study First Received: | March 20, 2009 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00867425 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Diabetes Internet Obesity Obesity with high cardiovascular risks |
|
Body Weight Signs and Symptoms Obesity Metabolic Diseases Diabetes Mellitus Nutrition Disorders |
Endocrine System Diseases Overweight Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
|
Body Weight Signs and Symptoms Obesity Metabolic Diseases Diabetes Mellitus Nutrition Disorders |
Endocrine System Diseases Overweight Overnutrition Cardiovascular Diseases Glucose Metabolism Disorders |
