Clinical trial NCT00867425: Translating the Diabetes Prevention Program Into a Virtual Lifestyle Management Program
Official title: Translating the Diabetes Prevention Program Into a Virtual Lifestyle Management Program: A Pilot Study in a Military Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes
Cardiovascular Disease
Keywords: Diabetes
Internet
Obesity
Obesity with high cardiovascular risks
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: U.S. Air Force Office of the Surgeon General
First posted: 2009-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in weight
timeFrame: 4 months
Secondary outcomes:
measure: Blood Pressure
timeFrame: 4 months
measure: Lipids
timeFrame: 4 months
measure: A1C (if applicable)
timeFrame: 4 months
measure: Physical Activity
timeFrame: 4 months
measure: Eating Behaviors
timeFrame: 4 months
measure: Health Related Quality of Life
timeFrame: 4 months
Other outcomes:
Locations:
city: Lackland AFB
country: United States
facility: Wilford Hall Medical Center
state: Texas
Study officials:
affiliation: University of Pittsburgh
name: Kathleen M McTigue, MD, MS, MPH
role: STUDY_DIRECTOR
References:
citation: Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.
citation: ADA. All About Diabetes. found at http://www.diabetes.org/about-diabetes.jsp. 2004.
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. doi: 10.2337/diacare.26.3.917.
citation: American Diabetes Association. Standards of medical care in diabetes. Diabetes Care. 2004 Jan;27 Suppl 1:S15-35. doi: 10.2337/diacare.27.2007.s15. No abstract available.