Translating the Diabetes Prevention Program Into a Virtual Lifestyle Management Program

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00867425
• Other study ID #: PRO08030183
• Secondary ID: FWH20080195H
• Status: Completed
• Phase: N/A
• First received: March 20, 2009
• Last updated: April 26, 2012
• Start date: April 2009
• Est. completion date: March 2010

Study information

• Verified date: April 2012
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 62 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Obesity

Intervention

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).

Locations

Country	Name	City	State
United States	Wilford Hall Medical Center	Lackland AFB	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	U.S. Air Force Office of the Surgeon General

Country where clinical trial is conducted

United States, 

References & Publications (4)

ADA. All About Diabetes. found at http://www.diabetes.org/about-diabetes.jsp. 2004.

American Diabetes Association. Standards of medical care in diabetes. Diabetes Care. 2004 Jan;27 Suppl 1:S15-35. Review. — View Citation

Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. — View Citation

Hogan P, Dall T, Nikolov P; American Diabetes Association. Economic costs of diabetes in the US in 2002. Diabetes Care. 2003 Mar;26(3):917-32. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight		4 months	No
Secondary	Blood Pressure		4 months	No
Secondary	Lipids		4 months	No
Secondary	A1C (if applicable)		4 months	No
Secondary	Physical Activity		4 months	No
Secondary	Eating Behaviors		4 months	No
Secondary	Health Related Quality of Life		4 months	No