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Clinical Trials/NCT00867425
NCT00867425
Completed
Not Applicable

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

University of Pittsburgh1 site in 1 country30 target enrollmentApril 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Pittsburgh
Enrollment
30
Locations
1
Primary Endpoint
Change in weight
Status
Completed
Last Updated
14 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
April 2009
End Date
March 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kathleen McTigue

Assistant Professor

University of Pittsburgh

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in weight

Time Frame: 4 months

Secondary Outcomes

  • 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)

Study Sites (1)

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