Diabetes Prevention Program Pilot

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Pre-diabetes

Treatments: Behavioral: DPP Program; Behavioral: Motivational Message; Behavioral: Financial Incentives

Study type: Interventional

Funder types: Other

Identifiers

NCT04651816

00010222

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be at least 18 years old and under age 65 AND

2. Body Mass Index ≥25 kg/m2 (≥23 kg/m2 if Asian) AND

3. Not be pregnant at time of enrollment AND

4. Have no previous diagnosis of type 1 or type 2 diabetes AND

5. Have a blood test result in the prediabetes range within the past year, meeting one of these specifications:

   1. Hemoglobin A1c: 5.7-6.4%, OR
   2. Fasting plasma glucose : 100-125 mg/dL, OR
   3. Two-hour plasma glucose (after a 75-gm glucose load): 140-199 mg/dL, OR
   4. Have a previous clinical diagnosis of gestational diabetes mellitus (GDM), AND

6. Not in hypertensive crisis with systolic over 180 and/or diastolic over 120

7. 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

8. Fluent in English AND

9. Own and carry an iPhone (running iOS version 10 or higher) or Android (running operating system 7 or higher) smartphone during waking hours

10. Internet access

11. Tablet or desktop/laptop computer with webcam for classes

12. Active email address

Exclusion criteria

1. Under 18 years old and over age 65

2. Body Mass Index <25 kg/m2 (<23 kg/m2 if Asian)

3. Pregnant at the time of enrollment

4. Previous diagnosis of type 1 or type 2 diabetes

5. Have a blood test result within the past year meeting one of these specifications:

   1. Hemoglobin A1c: not in range of 5.7-6.4%
   2. Fasting plasma glucose: not in range of 100-125 mg/dL
   3. Two-hour plasma glucose (after a 75-gm glucose load): not in range of 140-199 mg/dL
   4. No previous clinical diagnosis of gestational diabetes

6. 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)

7. 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)

8. Not fluent in English

9. Not own and carry an iPhone (running iOS version 10 or higher) or Android (running operating system 7 or higher) smartphone during waking hours.

10. Decisional impairment

11. Prisoner status

12. 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) .

13. Anyone who does not have internet access

14. Anyone who does not have tablet or desktop/laptop computer with webcam

15. Anyone who does not have an active email address

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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30 participants in 4 patient groups

Control PSH DPP only

Active Comparator group

Description:

This group will be enrolled the PSH DPP program. There will be two cohorts for this arm.

Treatment:

Behavioral: DPP Program

Treatment 1 Financial Incentives A

Experimental group

Description:

This group will receive gift cards as financial incentive to participate in the PSH DPP program. There will be two cohorts for this arm.

Treatment:

Behavioral: DPP Program

Behavioral: Financial Incentives

Treatment 2 Financial Incentives B

Experimental group

Description:

This group will receive gift cards as financial incentive to participate in the PSH DPP program. There will be two cohorts for this arm.

Treatment:

Behavioral: DPP Program

Behavioral: Financial Incentives

Treatment 3 Motivational Text Messaging

Experimental group

Description:

This group will receive text messages with motivational messages while participating in the PSH DPP program. There will be two cohorts for this arm.

Treatment:

Behavioral: DPP Program

Behavioral: Motivational Message