Diabetes Prevention Program Pilot

Study Overview
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Brief Summary
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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
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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.

Official Title
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Penn State Health (PSH) Diabetes Prevention Program (DPP) Pilot

Conditions
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Pre-diabetes

Intervention / Treatment
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* Behavioral: Financial Incentives
* Behavioral: Motivational Message
* Behavioral: DPP Program


Participation Criteria
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Eligibility Criteria
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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 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 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) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control PSH DPP only<br>This group will be enrolled the PSH DPP program. There will be two cohorts for this arm. | Behavioral: DPP Program<br>* All Participants will be enrolled in the DPP program.<br>|
| Experimental: Treatment 1 Financial Incentives A<br>This group will receive gift cards as financial incentive to participate in the PSH DPP program. There will be two cohorts for this arm. | Behavioral: Financial Incentives<br>* Participants will be entered into a lottery to receive a gift card for class attendance.<br>Behavioral: DPP Program<br>* All Participants will be enrolled in the DPP program.<br>|
| Experimental: Treatment 2 Financial Incentives B<br>This group will receive gift cards as financial incentive to participate in the PSH DPP program. There will be two cohorts for this arm. | Behavioral: Financial Incentives<br>* Participants will be entered into a lottery to receive a gift card for class attendance.<br>Behavioral: DPP Program<br>* All Participants will be enrolled in the DPP program.<br>|
| Experimental: Treatment 3 Motivational Text Messaging<br>This group will receive text messages with motivational messages while participating in the PSH DPP program. There will be two cohorts for this arm. | Behavioral: Motivational Message<br>* Participants will be sent motivational messages through out their participation in the PSH DPP program.<br>Behavioral: DPP Program<br>* All Participants will be enrolled in the DPP program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | Patients will be monitored through out the study for healthy weight loss. | 12 months | 
| Subject Retention | Participants will be tracked for retention throughout the study. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Participant blood pressure will be monitored through out the study for change. | 12 months | 
| A1c | Participant A1c will be monitored through out the study for change. | 12 months | 
| Total Cholesterol | Participant total cholesterol will be monitored through out the study for change. | 12 months | 
| Pregnancy Status | Participant pregnancy status will be reported throughout the study if status changes from baseline. | 12 months | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Participants will complete the KOOS survey as part of this study. | 12 months | 
| Quality of Life (SF-36) | Participants will complete the SF-36 as part of this study. | 12 months | 
| Opinions about PSH DPP program | Participants will provide feedback and opinions about the PSH DPP program via survey at the conclusion of the study. | 12 months |