Penn State Health (PSH) Diabetes Prevention Program (DPP) Pilot
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pre-diabetes
- Sponsor
- Penn State University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Subject Retention
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This initiative, which is a partnership between State College area Penn State Health ambulatory care clinics located off campus in the State College area, has two primary goals: 1) improve the health and quality of life of Penn State Health patients with pre-diabetes and 2) decrease associated health care costs due to type 2 diabetes and its complications. The results from the study may serve as a model for additional chronic disease prevention programs to implement in additional Penn State Health clinics in the future.
Detailed Description
Through this initiative, providers in Penn State Health ambulatory health care clinics (PSH clinics) will identify pre-diabetic patients to take part in a Diabetes Prevention Program (DPP), modeled after the Centers for Disease Control's (CDC) program. The DPP is a CDC-recognized lifestyle change program developed specifically to prevent type 2 diabetes. It is designed for people who have prediabetes or are at risk for type 2 diabetes, but who do not already have diabetes. We will be using the DPP distance learning program which allows online delivery of classes. A trained lifestyle coach leads the program to help subjects change certain aspects of their lifestyle, like eating healthier, reducing stress, and getting more physically activity. The program also includes group support. The DPP is a year-long program focused on long-term changes and lasting results. Key components of the program include a CDC-approved curriculum with lessons, handouts, and other resources; a lifestyle coach, specifically trained to lead the program; and a support group of people with similar goals and challenges. To that end, this study has multiple arms that will test whether participation in the PSH DPP - and exposure to motivational messages that encourage physical activity or participation in lotteries, an increasingly common strategy for behavioral motivation, - significantly improves program retention and health-related outcomes, compared to those who only participate in the PSH DPP.
Investigators
Dennis P. Scanlon
Distinguished Professor of Health Policy and Administration, Director of the Center for Health Care and Policy Research
Penn State University
Eligibility Criteria
Inclusion Criteria
- •Be at least 18 years old and under age 65 AND
- •Body Mass Index ≥25 kg/m2 (≥23 kg/m2 if Asian) AND
- •Not be pregnant at time of enrollment AND
- •Have no previous diagnosis of type 1 or type 2 diabetes AND
- •Have a blood test result in the prediabetes range within the past year, meeting one of these specifications:
- •Hemoglobin A1c: 5.7-6.4%, OR
- •Fasting plasma glucose : 100-125 mg/dL, OR
- •Two-hour plasma glucose (after a 75-gm glucose load): 140-199 mg/dL, OR
- •Have a previous clinical diagnosis of gestational diabetes mellitus (GDM), AND
- •Not in hypertensive crisis with systolic over 180 and/or diastolic over 120
Exclusion Criteria
- •Under 18 years old and over age 65
- •Body Mass Index \<25 kg/m2 (\<23 kg/m2 if Asian)
- •Pregnant at the time of enrollment
- •Previous diagnosis of type 1 or type 2 diabetes
- •Have a blood test result within the past year meeting one of these specifications:
- •Hemoglobin A1c: not in range of 5.7-6.4%
- •Fasting plasma glucose: not in range of 100-125 mg/dL
- •Two-hour plasma glucose (after a 75-gm glucose load): not in range of 140-199 mg/dL
- •No previous clinical diagnosis of gestational diabetes
- •Active hypertensive crisis with systolic over 180 and/or diastolic over 120 (patients in this category would be referred to primary care provider for immediate visit)
Outcomes
Primary Outcomes
Subject Retention
Time Frame: 12 months
Participants will be tracked for retention throughout the study.
Weight Loss
Time Frame: 12 months
Patients will be monitored through out the study for healthy weight loss.
Secondary Outcomes
- Total Cholesterol(12 months)
- Blood Pressure(12 months)
- Pregnancy Status(12 months)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(12 months)
- Opinions about PSH DPP program(12 months)
- A1c(12 months)
- Quality of Life (SF-36)(12 months)