Penn State Health Medical Group -- Park Avenue
State College, Pennsylvania, 16803, United States
NCT Number: NCT04651816
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.
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Notify Me18 year–64 year
All sexes
Interventional
Not applicable
State College, Pennsylvania, 16803, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be entered into a lottery to receive a gift card for class attendance.
Participants will be sent motivational messages through out their participation in the PSH DPP program.
All Participants will be enrolled in the DPP program.
Time frame: 12 months
Patients will be monitored through out the study for healthy weight loss.
Time frame: 12 months
Participants will be tracked for retention throughout the study.
Time frame: 12 months
Participant blood pressure will be monitored through out the study for change.
Time frame: 12 months
Participant A1c will be monitored through out the study for change.
Time frame: 12 months
Participant total cholesterol will be monitored through out the study for change.
Time frame: 12 months
Participant pregnancy status will be reported throughout the study if status changes from baseline.
Time frame: 12 months
Participants will complete the KOOS survey as part of this study.
Time frame: 12 months
Participants will complete the SF-36 as part of this study.
Time frame: 12 months
Participants will provide feedback and opinions about the PSH DPP program via survey at the conclusion of the study.
Penn State University
Other
Penn State Health (PSH) Diabetes Prevention Program (DPP) Pilot
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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