Translating the Diabetes Prevention Program Into a Virtual Lifestyle Management Program

NCT00867425 | Completed DMC

• 2 other identifiers: PRO08030183FWH20080195H
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabetes; Cardiovascular Disease

Keywords

Diabetes; Internet; Obesity; Obesity with high cardiovascular risks

Outcome Measures

Primary Outcomes (1)

• Change in weight

  4 months

Secondary Outcomes (6)

• Blood Pressure

  4 months

• Lipids

  4 months

• A1C (if applicable)

  4 months

• Physical Activity

  4 months

• Eating Behaviors

  4 months

Study Arms (1)

Intervention

EXPERIMENTAL

Behavioral: Virtual Lifestyle Management

Interventions

Virtual Lifestyle Management BEHAVIORAL

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).

Also known as: Diabetes Prevention Program

Intervention

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• U.S. Air Force Office of the Surgeon General: collaborator

Study Sites (1)

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

Related Publications (4)

• 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.

  PMID: 12453955 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 12610059 BACKGROUND

• 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.

  PMID: 14693923 BACKGROUND

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kathleen M McTigue, MD, MS, MPH

  University of Pittsburgh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: March 23, 2009
• Study Start: April 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 27, 2012

Record last verified: 2012-04

Locations

US (1)