Tailored DPP Intervention for Prediabetes

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Not UCLA undergrad, Not T-UP eligible

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

Duration: 9 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to enhance reach and uptake of diabetes prevention among young adults, with a focus on recruiting underserved and high-need students who face additional challenges, including food and financial insecurity. The specific aims are to: 1) Evaluate the efficacy of adolescents and young adults (AYA)-tailored version of the University of California Diabetes Prevention Program (UC DPP) for mitigating type 2 diabetes risk (i.e., weight change) in a pre/post pilot trial. The investigators hypothesize that the AYA-tailored intervention will be effective at producing 5% weight loss from baseline to program completion (at 9-months); and, 2) Assess the feasibility and acceptability of an AYA-tailored version of the UC DPP program. The investigators hypothesize that it will be feasible to recruit the desired number of participants given proposed innovative outreach strategies, and that the AYA-tailored intervention will be deemed acceptable to participants both qualitatively and in regards to their retention in the program at rates similar to the larger UC DPP. The investigators will randomize participants to the AYA-tailored DPP cohort vs control cohort. Control participants will be offered the opportunity to participate in the AYA-tailored DPP in the following academic year. Participants will be organized into groups within their DPP cohort based on their student status and/or place of residence. The intervention will include 19 sessions (18 in-person and 1 on-demand) covering 24 DPP modules; each session is approximately an hour in length and will be moderated by a lifestyle coach. At the end of each session, intervention participants will receive an email/text with a unique link to a brief REDCap survey to ascertain acceptability of the session. Control group will receive access to materials about study habits, alcohol use, and financial literacy. Control group will receive materials via e-mail for participants to review on their own time and will receive acceptability surveys. A research assistant (RA) will meet with control participants via Zoom to explain the materials. Participants will complete baseline and 9-month follow-up assessments. Participants will complete a 30 minute questionnaire via REDCap and height/weight measurements will be collected by a RA. Participants will be asked to self-report weight and physical activity at the end of the fall and winter quarter; data will be collected via brief REDCap survey.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the Tailored DPP Intervention generally safe for humans?

DPP-4 inhibitors, which are part of the Tailored DPP Intervention, have been used for over 10 years in diabetes treatment and are generally considered safe. They do not increase the risk of major heart events and have a favorable safety profile, with ongoing studies to monitor any potential side effects like pancreatitis or hypoglycemia. ^{1 2 3 4 5}

How is the Tailored DPP Intervention treatment different from other treatments for prediabetes?

The Tailored DPP Intervention is unique because it adapts the traditional Diabetes Prevention Program (DPP) using technology, such as daily text messaging and Fitbit devices, to make it more accessible and easier to follow compared to in-person programs. This approach aims to overcome barriers like the commitment to a yearlong program by offering a more flexible and convenient option for people with prediabetes. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Tailored DPP Intervention for prediabetes?

The Tailored DPP Intervention is based on the Diabetes Prevention Program (DPP), which has been shown to prevent or delay type 2 diabetes in people with prediabetes. Additionally, a study found that using technology like text messaging and fitness trackers to deliver DPP content can effectively support lifestyle changes in primary care settings. ^{10 11 12 13 14}

Who Is on the Research Team?

Lauren Wisk, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for young adults at risk of type 2 diabetes, particularly those who are underserved and dealing with challenges like food and financial insecurity. Participants should be students willing to engage in a program aimed at preventing diabetes.

Inclusion Criteria

Participants who are currently enrolled (either full time or part time) as an undergraduate at UCLA and meet criteria for the T-UP Wellness Program (students who have a BMI of ≥25 (≥23 for those self-identifying as Asian) and either documented prediabetes or identified as high-risk on a CDC questionnaire)

Exclusion Criteria

Participants who are not currently enrolled (either full time or part time) as an undergraduate at UCLA and do not meet criteria for the T-UP Wellness Program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the AYA-tailored Diabetes Prevention Program intervention, including 19 sessions over the academic year

9 months

18 in-person sessions, 1 on-demand session

Control

Control group receives materials on study habits, alcohol use, and financial literacy via email, with Zoom sessions for explanation

9 months

3 Zoom sessions

Follow-up

Participants are monitored for changes in weight and quality of life at 9-month follow-up

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Tailored DPP Intervention

Trial Overview The study tests a tailored version of the UC Diabetes Prevention Program (DPP) designed for adolescents and young adults. It involves group sessions led by lifestyle coaches over nine months, aiming to reduce diabetes risk through weight loss.

How Is the Trial Designed?

Group I: Diabetes Prevention Program (DPP) group Experimental Treatment 1 Intervention

The DPP group will receive a tailored Diabetes Prevention Program.

Group II: Control group Active Control 1 Intervention

The control group will receive access to materials on study habits (fall), alcohol use (winter), and financial literacy (spring). The control group will receive the materials via e-mail for participants to review on their own time. A research assistant will meet with control participants via Zoom to explain the materials. The Zoom session will take approximately 1 hour.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Published Research Related to This Trial

Dipeptidyl peptidase (DPP)-4 inhibitors have been shown to neither increase nor decrease the risk of major cardiovascular events in high-risk patients, based on several completed cardiovascular safety trials.

The differences in outcomes between cardiovascular safety trials and earlier studies with metabolic endpoints may be attributed to the distinct patient populations and trial designs, highlighting the need for careful consideration of these factors when assessing drug efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analyses of Results From Cardiovascular Safety Trials With DPP-4 Inhibitors: Cardiovascular Outcomes, Predefined Safety Outcomes, and Pooled Analysis and Meta-analysis. Mannucci, E., Mosenzon, O., Avogaro, A.[2019]

A study analyzing FDA Adverse Event Reporting System data from January 2013 to March 2022 found that different DPP-4 inhibitors have varying risks for serious side effects, such as acute kidney injury and pemphigoid, which can guide treatment choices for diabetes patients.

Specifically, alogliptin showed a significantly lower risk of acute kidney injury compared to sitagliptin, but a higher risk of pemphigoid, highlighting the importance of selecting the appropriate DPP-4 inhibitor based on a patient's specific health concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Adverse Events Occurred During Administration of Dipeptidyl Peptidase-4 Inhibitor in Patients with Diabetes Using FDA Adverse Event Reporting System. Ogura, T., Shiraishi, C.[2023]

Incretin-based therapies, including DPP-4 inhibitors and GLP-1 receptor agonists, provide effective glycemic control in type 2 diabetes with lower rates of hypoglycemia compared to other diabetes medications, based on a review of 112 clinical trials lasting at least 26 weeks.

The most common side effects were infections for DPP-4 inhibitors and gastrointestinal issues for GLP-1 receptor agonists, but serious concerns like pancreatitis and thyroid tumors were rare, indicating a favorable safety profile, though long-term safety monitoring is still necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the safety of incretin-based therapies in type 2 diabetes. Evans, M., Bain, SC., Vora, J.[2019]

Technology-assisted diabetes prevention programs (DPP), including mobile text messaging, apps, and telehealth, have shown potential for clinically meaningful weight loss and cost-effectiveness in preventing type 2 diabetes.

These interventions can be widely distributed and sustained, making them accessible options for individuals at risk for diabetes, although further research is needed to identify the most effective combination of features for these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Technology-Assisted Interventions for Diabetes Prevention. Grock, S., Ku, JH., Kim, J., et al.[2022]

A systematic review of 11 trials found that lower-intensity lifestyle interventions for prediabetes showed limited effectiveness, with only one high-quality study demonstrating a 3-kg weight reduction and a 0.2% decrease in HbA1c over 6 months.

The overall evidence for these lower-intensity interventions is weak, highlighting the need for more robust research to explore their potential in diabetes prevention, especially given the low participation in traditional, high-intensity programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower-Intensity Interventions for Prediabetes: A Systematic Review. Tseng, E., Lam, KY., Meza, KA., et al.[2023]

The Intensive Lifestyle Intervention (ILI) in the Diabetes Prevention Program (DPP) effectively helped approximately 3800 high-risk adults with prediabetes achieve weight loss through dietary and exercise modifications, demonstrating a practical approach to delaying or preventing type 2 diabetes.

The DPP and its follow-up, the DPP Outcomes Study (DPPOS), highlight the importance of lifestyle changes in managing prediabetes, particularly in a diverse population, suggesting that these interventions can be tailored to various ethnic backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of Diabetes Through the Lifestyle Intervention: Lessons Learned from the Diabetes Prevention Program and Outcomes Study and its Translation to Practice. Hoskin, MA., Bray, GA., Hattaway, K., et al.[2019]

The Diabetes Prevention Program (DPP) effectively identified high-risk adults for type 2 diabetes, with 27% of participants showing impaired glucose tolerance and 13% having previously undiagnosed diabetes based on oral glucose tolerance tests (OGTT).

Fasting capillary glucose levels, along with age and BMI, significantly improved the screening process for high-risk individuals across various ethnic groups, suggesting it can enhance the efficiency of diabetes prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to identify adults at high risk for type 2 diabetes: the Diabetes Prevention Program. [2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Patient and provider prediabetes knowledge, attitudes, and behavior in a large urban family medicine practice. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

DPPFit: Developing and Testing a Technology-Based Adaptation of the Diabetes Prevention Program (DPP) to Address Prediabetes in a Primary Care Setting. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The effectiveness of goal setting on glycaemic control for people with type 2 diabetes and prediabetes: A systematic review and meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Study protocol: Behavioral economics and self-determination theory to change diabetes risk (BEST Change). [2023]

5. England pubmed.ncbi.nlm.nih.gov

Differential effect of interventions in patients with prediabetes stratified by a machine learning-based diabetes progression prediction model. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Analyses of Results From Cardiovascular Safety Trials With DPP-4 Inhibitors: Cardiovascular Outcomes, Predefined Safety Outcomes, and Pooled Analysis and Meta-analysis. [2019]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of Adverse Events Occurred During Administration of Dipeptidyl Peptidase-4 Inhibitor in Patients with Diabetes Using FDA Adverse Event Reporting System. [2023]

8. England pubmed.ncbi.nlm.nih.gov

A systematic review of the safety of incretin-based therapies in type 2 diabetes. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Ten years of experience with DPP-4 inhibitors for the treatment of type 2 diabetes mellitus. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Factors contributing to the adverse drug reactions associated with the dipeptidyl peptidase-4 (DPP-4) inhibitors: A scoping review. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

A Review of Technology-Assisted Interventions for Diabetes Prevention. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Lower-Intensity Interventions for Prediabetes: A Systematic Review. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Prevention of Diabetes Through the Lifestyle Intervention: Lessons Learned from the Diabetes Prevention Program and Outcomes Study and its Translation to Practice. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Strategies to identify adults at high risk for type 2 diabetes: the Diabetes Prevention Program. [2021]