Pre-diabetesNCT04651816
Diabetes Prevention Program Pilot
A study testing Financial Incentives, Motivational Message and DPP Program in people with Pre-diabetes, run by Penn State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- Financial Incentives, Motivational Message and DPP Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2021to 8 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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%
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Health Medical Group -- Park Avenue
State College, Pennsylvania, 16803
About this study
Official title: Penn State Health (PSH) Diabetes Prevention Program (DPP) Pilot
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.
Read the 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.
- Conditions
- Pre-diabetes
- Being tested
- Financial Incentives, Motivational Message, DPP Program
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial IncentivesBehavioural
Participants will be entered into a lottery to receive a gift card for class attendance.
Motivational MessageBehavioural
Participants will be sent motivational messages through out their participation in the PSH DPP program.
DPP ProgramBehavioural
All Participants will be enrolled in the DPP program.
| Study group | Role | What they receive |
|---|---|---|
| Control PSH DPP only | Active comparator | This group will be enrolled the PSH DPP program. There will be two cohorts for this arm. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Motivational Message; Behavioral: DPP Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Patients will be monitored through out the study for healthy weight loss.
Measured: 12 months
Subject Retention
Participants will be tracked for retention throughout the study.
Measured: 12 months
Secondary outcomes (7)
Blood Pressure
Participant blood pressure will be monitored through out the study for change.
Measured: 12 months
A1c
Participant A1c will be monitored through out the study for change.
Measured: 12 months
Total Cholesterol
Participant total cholesterol will be monitored through out the study for change.
Measured: 12 months
Pregnancy Status
Participant pregnancy status will be reported throughout the study if status changes from baseline.
Measured: 12 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Participants will complete the KOOS survey as part of this study.
Measured: 12 months
Quality of Life (SF-36)
Participants will complete the SF-36 as part of this study.
Measured: 12 months
Opinions about PSH DPP program
Participants will provide feedback and opinions about the PSH DPP program via survey at the conclusion of the study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start25 May 2021
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Milton S. Hershey Medical Center
- Responsible party
- Principal investigator, Dennis P. Scanlon, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651816
- Sponsor's protocol ID
- 00010222
- Status last verified
- Sep 2023
- First submitted
- 24 Nov 2020
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Do to be determined.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penn State Health (PSH) Diabetes Prevention Program (DPP) Pilot
- ClinicalTrials.gov ID
- NCT04651816
- Acronym / sponsor ID
- 00010222
- Conditions
- Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Milton S. Hershey Medical Center
- Study start
- 25 May 2021 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control PSH DPP only | Active comparator | Behavioral: DPP ProgramThis group will be enrolled the PSH DPP program. There will be two cohorts for this arm. |
| Treatment 1 Financial Incentives A | Experimental | Behavioral: Financial Incentives, Behavioral: DPP ProgramThis group will receive gift cards as financial incentive to participate in the PSH DPP program. There will be two cohorts for this arm. |
| Treatment 2 Financial Incentives B | Experimental | Behavioral: Financial Incentives, Behavioral: DPP ProgramThis group will receive gift cards as financial incentive to participate in the PSH DPP program. There will be two cohorts for this arm. |
| Treatment 3 Motivational Text Messaging | Experimental | Behavioral: Motivational Message, Behavioral: DPP ProgramThis group will receive text messages with motivational messages while participating in the PSH DPP program. There will be two cohorts for this arm. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (19 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial IncentivesParticipants will be entered into a lottery to receive a gift card for class attendance. | Behavioural | Treatment 1 Financial Incentives A, Treatment 2 Financial Incentives B |
| Motivational MessageParticipants will be sent motivational messages through out their participation in the PSH DPP program. | Behavioural | Treatment 3 Motivational Text Messaging |
| DPP ProgramAll Participants will be enrolled in the DPP program. | Behavioural | Control PSH DPP only, Treatment 1 Financial Incentives A, Treatment 2 Financial Incentives B, Treatment 3 Motivational Text Messaging |
Primary outcome
Weight Loss
Time frame: 12 months
Patients will be monitored through out the study for healthy weight loss.
Subject Retention
Time frame: 12 months
Participants will be tracked for retention throughout the study.
7 secondary outcomes
Blood Pressure
Time frame: 12 months
A1c
Time frame: 12 months
Total Cholesterol
Time frame: 12 months
Pregnancy Status
Time frame: 12 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 12 months
Quality of Life (SF-36)
Time frame: 12 months
Opinions about PSH DPP program
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: Undecided. Do to be determined.
Related trials for Pre-diabetes
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruiting
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Not yet recruiting
Effects of Mango on Insulin Sensitivity in Prediabetes
Pre Diabetes
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Incentives, Motivational Message and DPP Program in people with Pre-diabetes, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.