Penn State Health (PSH) Diabetes Prevention Program (DPP) Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Subject Retention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants will not know what intervention group they will be assigned to (motivational messaging, incentives or control group).
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Be an established patient at a Penn State Health clinic in State College, PA (i.e. have at least one visit in past 18 months) AND
- •Fluent in English AND
- •Own and carry an iPhone (running iOS version 10 or higher) or Android (running operating system 7 or higher) smartphone during waking hours
- •Internet access
- •Tablet or desktop/laptop computer with webcam for classes
- •Active email address
排除标准
- •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)
- •Not be an established patient at a Penn State Health clinic in State College, PA (i.e. have not had at least one visit in the past 18 months)
- •Not fluent in English
- •Not own and carry an iPhone (running iOS version 10 or higher) or Android (running operating system 7 or higher) smartphone during waking hours.
- •Decisional impairment
- •Prisoner status
- •Actively taking any of the following drug classes: Biguanides, Sulfonylureas (SU), Thiazolidendiones (TZD), Meglitinides, Alpha-glucosidase inhibitors, Dipetidyl Peptidase-IV (DPP4) inhibitors, Insulin , Sodiumglucose transporter 2 (SGLT2) inhibitors, glucagon-like peptide-1 (GLP-1) .
- •Anyone who does not have internet access
- •Anyone who does not have tablet or desktop/laptop computer with webcam
- •Anyone who does not have an active email address
结局指标
主要结局
Subject Retention
时间窗: 12 months
Participants will be tracked for retention throughout the study.
Weight Loss
时间窗: 12 months
Patients will be monitored through out the study for healthy weight loss.
次要结局
- 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)
研究者
Dennis P. Scanlon
Distinguished Professor of Health Policy and Administration, Director of the Center for Health Care and Policy Research
Penn State University