Diabetes Prevention Program Pilot

NCT04651816 | Completed

• 1 other identifier: 00010222
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Blood Pressure

  12 months

• A1c

  12 months

• Total Cholesterol

  12 months

• Pregnancy Status

  12 months

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  12 months

Study Arms (4)

Control PSH DPP only

ACTIVE COMPARATOR

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

Behavioral: DPP Program

Treatment 1 Financial Incentives A

EXPERIMENTAL

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; Behavioral: DPP Program

Treatment 2 Financial Incentives B

EXPERIMENTAL

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; Behavioral: DPP Program

Treatment 3 Motivational Text Messaging

EXPERIMENTAL

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; Behavioral: DPP Program

Interventions

Financial Incentives BEHAVIORAL

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

Treatment 1 Financial Incentives A; Treatment 2 Financial Incentives B

Motivational Message BEHAVIORAL

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

Treatment 3 Motivational Text Messaging

DPP Program BEHAVIORAL

All Participants will be enrolled in the DPP program.

Control PSH DPP only; Treatment 1 Financial Incentives A; Treatment 2 Financial Incentives B; Treatment 3 Motivational Text Messaging

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• Milton S. Hershey Medical Center: collaborator

Study Sites (1)

Penn State Health Medical Group -- Park Avenue

State College, Pennsylvania, 16803, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know what intervention group they will be assigned to (motivational messaging, incentives or control group).
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Health Policy and Administration, Director of the Center for Health Care and Policy Research

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 3, 2020
• Study Start: May 25, 2021
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-09

Locations

US (1)