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Diabetes Prevention Program Pilot

Primary Purpose

Pre-diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Financial Incentives

Motivational Message

DPP Program

About this trial

This is an interventional prevention trial for Pre-diabetes

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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:
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
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:
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
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

Sites / Locations

Penn State Health Medical Group -- Park Avenue

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Control PSH DPP only

Treatment 1 Financial Incentives A

Treatment 2 Financial Incentives B

Treatment 3 Motivational Text Messaging

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Weight Loss

Patients will be monitored through out the study for healthy weight loss.

Subject Retention

Participants will be tracked for retention throughout the study.

Secondary Outcome Measures

Blood Pressure

Participant blood pressure will be monitored through out the study for change.

A1c

Participant A1c will be monitored through out the study for change.

Total Cholesterol

Participant total cholesterol will be monitored through out the study for change.

Pregnancy Status

Participant pregnancy status will be reported throughout the study if status changes from baseline.

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Participants will complete the KOOS survey as part of this study.

Quality of Life (SF-36)

Participants will complete the SF-36 as part of this study.

Opinions about PSH DPP program

Participants will provide feedback and opinions about the PSH DPP program via survey at the conclusion of the study.

Full Information

NCT ID

NCT04651816

First Posted

November 24, 2020

Last Updated

September 1, 2023

Sponsor

Penn State University

Collaborators

Milton S. Hershey Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04651816

Brief Title

Diabetes Prevention Program Pilot

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

May 25, 2021 (Actual)

Primary Completion Date

August 8, 2023 (Actual)

Study Completion Date

August 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Penn State University

Collaborators

Milton S. Hershey Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pre-diabetes

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Participant

Masking Description

Participants will not know what intervention group they will be assigned to (motivational messaging, incentives or control group).

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control PSH DPP only

Arm Type

Active Comparator

Arm Description

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

Arm Title

Treatment 1 Financial Incentives A

Arm Type

Experimental

Arm 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.

Arm Title

Treatment 2 Financial Incentives B

Arm Type

Experimental

Arm 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.

Arm Title

Treatment 3 Motivational Text Messaging

Arm Type

Experimental

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

Financial Incentives

Intervention Description

Participants will be entered into a lottery to receive a gift card for class attendance.

Intervention Type

Behavioral

Intervention Name(s)

Motivational Message

Intervention Description

Participants will be sent motivational messages through out their participation in the PSH DPP program.

Intervention Type

Behavioral

Intervention Name(s)

DPP Program

Intervention Description

All Participants will be enrolled in the DPP program.

Primary Outcome Measure Information:

Title

Weight Loss

Description

Patients will be monitored through out the study for healthy weight loss.

Time Frame

12 months

Title

Subject Retention

Description

Participants will be tracked for retention throughout the study.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Blood Pressure

Description

Participant blood pressure will be monitored through out the study for change.

Time Frame

12 months

Title

A1c

Description

Participant A1c will be monitored through out the study for change.

Time Frame

12 months

Title

Total Cholesterol

Description

Participant total cholesterol will be monitored through out the study for change.

Time Frame

12 months

Title

Pregnancy Status

Description

Participant pregnancy status will be reported throughout the study if status changes from baseline.

Time Frame

12 months

Title

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Description

Participants will complete the KOOS survey as part of this study.

Time Frame

12 months

Title

Quality of Life (SF-36)

Description

Participants will complete the SF-36 as part of this study.

Time Frame

12 months

Title

Opinions about PSH DPP program

Description

Participants will provide feedback and opinions about the PSH DPP program via survey at the conclusion of the study.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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 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

Facility Information:

Facility Name

Penn State Health Medical Group -- Park Avenue

City

State College

State/Province

Pennsylvania

ZIP/Postal Code

16803

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Do to be determined.

Learn more about this trial

Diabetes Prevention Program Pilot

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