Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2021-05-25
2023-08-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
PREVENTION
SINGLE
Study Groups
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Control PSH DPP only
This group will be enrolled the PSH DPP program. There will be two cohorts for this arm.
DPP Program
All Participants will be enrolled in the DPP program.
Treatment 1 Financial Incentives A
This group will receive gift cards as financial incentive to participate in the PSH DPP program. There will be two cohorts for this arm.
Financial Incentives
Participants will be entered into a lottery to receive a gift card for class attendance.
DPP Program
All Participants will be enrolled in the DPP program.
Treatment 2 Financial Incentives B
This group will receive gift cards as financial incentive to participate in the PSH DPP program. There will be two cohorts for this arm.
Financial Incentives
Participants will be entered into a lottery to receive a gift card for class attendance.
DPP Program
All Participants will be enrolled in the DPP program.
Treatment 3 Motivational Text Messaging
This group will receive text messages with motivational messages while participating in the PSH DPP program. There will be two cohorts for this arm.
Motivational Message
Participants will be sent motivational messages through out their participation in the PSH DPP program.
DPP Program
All Participants will be enrolled in the DPP program.
Interventions
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Financial Incentives
Participants will be entered into a lottery to receive a gift card for class attendance.
Motivational Message
Participants will be sent motivational messages through out their participation in the PSH DPP program.
DPP Program
All Participants will be enrolled in the DPP program.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
64 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Penn State University
OTHER
Responsible Party
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Dennis P. Scanlon
Distinguished Professor of Health Policy and Administration, Director of the Center for Health Care and Policy Research
Locations
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Penn State Health Medical Group -- Park Avenue
State College, Pennsylvania, United States
Countries
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Other Identifiers
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00010222
Identifier Type: -
Identifier Source: org_study_id
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