Translating the Diabetes Prevention Program Into a Virtual Lifestyle Management Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Translating the Diabetes Prevention Program Into a Virtual Lifestyle Management Program: A Pilot Study in a Military Community

Conditions
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Obesity, Diabetes, Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Virtual Lifestyle Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight (BMI > 25 kg/m2) diagnosis of at least one of the following: hypertension, dyslipidemia, type 2 diabetes, glucose intolerance receive health care at the 59th Medical Wing of the US Air Force at least weekly access to a computer with high-speed internet at least weekly access to a scale able to attend an in-person orientation session able to understand and sign informed consent agree to participate in the VLM program and evaluation Exclusion Criteria: known deployment within 6 months Primary care physician determination that moderate physical activity and/or a low-fat diet are not safe or appropriate pregnancy breastfeeding current weight loss therapy history of bariatric surgery plans to have bariatric surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Virtual Lifestyle Management<br>* 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).<br>* Other names: Diabetes Prevention Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  | 4 months | 
| Lipids |  | 4 months | 
| A1C (if applicable) |  | 4 months | 
| Physical Activity |  | 4 months | 
| Eating Behaviors |  | 4 months | 
| Health Related Quality of Life |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Internet, Obesity, Obesity with high cardiovascular risks