NDPP-Flex for Prediabetes

(NDPP-Flex Trial)

No longer recruiting at 1 trial location

Overseen By Jayna DeRoeck

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Denver Health and Hospital Authority

Must not be taking: Anti-hyperglycemics

Disqualifiers: Pregnancy, Diabetes, Prior NDPP, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two versions of a program to help people with prediabetes avoid developing diabetes. Participants will either follow the standard National Diabetes Prevention Program (NDPP) or a new version called NDPP-Flex, which allows personalized goal-setting and adjustments. The trial aims to determine which approach better improves blood sugar levels and helps more participants return to normal blood sugar. People diagnosed with prediabetes who are patients at Denver Health and have a BMI of 20 or higher (18.5 or higher for those identifying as Asian) may be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative diabetes prevention strategies.

Do I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anti-hyperglycemic medication like metformin.

Will I have to stop taking my current medications?

If you are taking anti-hyperglycemic medication (like metformin), you cannot participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What prior data suggests that NDPP-Flex and the standard NDPP are safe for participants with prediabetes?

Research has shown that the National Diabetes Prevention Program (NDPP), on which NDPP-Flex is based, effectively lowers the risk of developing type 2 diabetes. In use since 2012, this program is known to reduce diabetes risk by 50%. NDPP-Flex offers a more personalized approach, helping individuals manage their diabetes risk through flexible goal-setting. Studies have found that NDPP-Flex leads to better blood sugar control than the standard NDPP. No specific reports of side effects or safety issues have emerged with NDPP-Flex, indicating it is well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about NDPP-Flex for prediabetes because it offers a personalized approach to lifestyle changes. Unlike the traditional National Diabetes Prevention Program (NDPP), NDPP-Flex allows participants to set individually tailored goals that can be adjusted over time, rather than adhering to a one-size-fits-all plan. This flexibility helps participants avoid the discouragement of all-or-nothing thinking by focusing on achievable, personalized milestones. Additionally, the program includes a simple goal-setting worksheet designed to be accessible even for those with low literacy, potentially making it more inclusive and effective for a broader audience.

What evidence suggests that this trial's treatments could be effective for prediabetes?

Research has shown that the National Diabetes Prevention Program (NDPP), one of the treatment arms in this trial, effectively lowers the risk of developing diabetes. One study found that participants in the NDPP reduced their chances of developing diabetes by 58% through lifestyle changes. Participants also often lose a significant amount of weight, typically between 4.2% and 4.3%, which further helps reduce their diabetes risk. The NDPP-Flex, another treatment arm in this trial, is a new version of this program that focuses on setting personal goals and being flexible. Although specific data on NDPP-Flex's effectiveness is not yet available, its foundation on the successful NDPP suggests it could help manage prediabetes. ^{6 7 8 9 10}

Who Is on the Research Team?

Rocio Pereira, MD

Principal Investigator

Denver Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with prediabetes, indicated by an A1C level of 5.7-6.4%, who are patients at Denver Health and have a BMI ≥20 kg/m2 (or ≥18.5 kg/m2 if Asian). It's not open to those who've done NDPP before, take diabetes medication like metformin, are pregnant, or have been diagnosed with diabetes.

Inclusion Criteria

You have a condition called prediabetes, which means your blood sugar levels are higher than normal but not high enough to be called diabetes.

You need to have a certain amount of body weight for your height.

Established patient at Denver Health

Exclusion Criteria

Currently pregnant

I have diabetes (type 1 or 2).

You have previously taken part in the NDPP (National Diabetes Prevention Program).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants enroll in classes randomized to deliver NDPP-Flex or the standard NDPP, focusing on personalized goal setting and lifestyle intervention

12 months

Weekly sessions

Follow-up

Participants are monitored for changes in A1C and achievement of normoglycemia

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NDPP
• NDPP-Flex

Trial Overview The study compares NDPP-Flex—a modified version of the National Diabetes Prevention Program—with the standard program to see which is better at improving blood sugar levels and helping more people reach normal blood sugar levels.

How Is the Trial Designed?

Group I: NDPP-Flex Experimental Treatment 1 Intervention

NDPP-Flex. The primary difference between NDPP-Flex and the standard NDPP is the approach to goal setting. In NDPP-Flex, coaches use the latest CDC-published curriculum, but adapted such that participants are encouraged to 1) set attainable, individually-tailored goals for risk-reduction, 2) adjust goals over time as needed, and 3) avoid all-or-nothing assessments of goal attainment. At each session, coaches provide a goal setting worksheet (see excerpt) with a simple, fillable format to better accommodate low literacy (e.g., "I will limit my soda and sugary drinks to \_\_ per day").

Group II: National Diabetes Prevention Program Active Control 1 Intervention

The Diabetes Prevention Program was a successful clinical trial demonstrating that intensive lifestyle support for weight loss reduced diabetes incidence by 58%. The intervention was translated into the National Diabetes Prevention Program (NDPP) and disseminated by the Centers for Disease Control and Prevention as a yearlong group-based program since 2012.

NDPP is already approved in United States for the following indications:

Approved in United States as National Diabetes Prevention Program for:

• Type 2 diabetes prevention

Who Is Running the Clinical Trial?

Denver Health and Hospital Authority

Lead Sponsor

Trials

106

Recruited

403,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

The NHS Diabetes Prevention Programme (NDPP) significantly reduced the conversion rate from nondiabetic hyperglycaemia (NDH) to type 2 diabetes mellitus (T2DM), with a hazard ratio of 0.80, indicating a 20% lower risk for those referred to the program compared to those not referred.

In a cohort study of 18,470 patients referred to the NDPP, the probability of not converting to T2DM at 36 months was 87.3% for those referred, compared to 84.6% for those not referred, suggesting the program is effective in preventing diabetes in at-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Referral to the NHS Diabetes Prevention Programme and conversion from nondiabetic hyperglycaemia to type 2 diabetes mellitus in England: A matched cohort analysis. Ravindrarajah, R., Sutton, M., Reeves, D., et al.[2023]

The pilot program successfully delivered the National Diabetes Prevention Program (NDPP) content to prediabetic patients through a mobile device, indicating that digital platforms can be effective for health interventions.

Patient and staff feedback suggested positive engagement with the virtual health coach, highlighting the potential for mobile health solutions to support diabetes prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Findings of the Delivery of the National Diabetes Prevention Program via a Mobile Application. Tiase, VL., Licata, M., Fleck, EM.[2018]

The Norfolk Diabetes Prevention Study (NDPS) lifestyle intervention significantly improved glycaemic control in people with newly diagnosed type 2 diabetes, particularly when supported by trained peer mentors, showing a notable reduction in HbA1c levels after 12 months.

Participants under 65 years old experienced greater benefits from the intervention, and those using oral hypoglycaemic medications had even lower HbA1c levels in the intervention group, although the overall effect was modest and not sustained after 24 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Norfolk diabetes prevention lifestyle intervention (NDPS) on glycaemic control in screen-detected type 2 diabetes: a randomised controlled trial. Sampson, M., Clark, A., Bachmann, M., et al.[2023]

The National Diabetes Prevention Program (NDPP) delivered via Zoom by Cooperative Extension personnel showed promising results, with 44% of participants achieving a weight loss of 5% or more, compared to only 7% in the Facebook group.

Both delivery methods had similar attendance and retention rates, indicating that remote group formats can effectively engage rural residents with prediabetes in lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Comparative Effectiveness for the Delivery of the National Diabetes Prevention Program through Cooperative Extension in Rural Communities. Gorczyca, AM., Washburn, RA., Smith, P., et al.[2022]

The evaluation of an EHR-based referral system for prediabetes in two rural health care organizations identified key barriers, including challenges in timely communication and the need for more education for both patients and providers.

Best practices for successful implementation included starting with a small-scale approach, ensuring the referral process is manageable, and involving providers in discussions about referrals, highlighting the importance of collaboration among competing health organizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing electronic health record-based National Diabetes Prevention Program referrals in a rural county. Olsen, J., Peterson, S., Stevens, A.[2022]

The NDPP-Flex program, which allows participants to set flexible and personalized goals, resulted in a significant reduction in glycated hemoglobin (HbA1c) levels compared to the standard NDPP, indicating better blood sugar control.

While retention rates, physical activity, and weight loss were similar between NDPP-Flex and standard NDPP, NDPP-Flex participants were four times more likely to achieve normoglycemia, suggesting that a patient-centered approach may enhance diabetes management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Goal-Setting in the National Diabetes Prevention Program: A Pilot Study. Ritchie, ND., Sauder, KA., Kaufmann, PG., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7445538/

Current Perspectives on the Impact of the National ... Reports show a promising 4.2% mean weight loss for in-person NDPP classes and 4.3% weight loss for virtual programs. These are impressive ...

2. diabetesjournals.org diabetesjournals.org/care/article/48/7/1180/157485/Cost-effectiveness-of-the-National-Diabetes

Cost-effectiveness of the National Diabetes Prevention Program Compared with nonenrollees, each NDPP enrollee had an average reduction of $4,552 (95% CI −13,231, 2,014) in 2-year total direct medical costs.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0168822723005983

Uptake, retention, and outcomes of the National Diabetes ... Between 2012 and 2016, 36% of enrollees achieved 5% weight loss and 42% reported at least 150 min of physical activity per week [4]. CDC-recognized lifestyle ...

4. coveragetoolkit.org coveragetoolkit.org/about-national-dpp/evidence/

Evidence A total of 1,079 participants experienced a lifestyle intervention that resulted in a 58% reduction in the rate of diabetes.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12178621/

Cost-effectiveness of the National Diabetes Prevention ... Compared with nonenrollees, each NDPP enrollee had an average reduction of $4,552 (95% CI −13,231, 2,014) in 2-year total direct medical costs. Cost savings ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10234737/

Glycemic Improvement and Health Equity in the National ... Our findings align with new evidence that the NDPP reduces diabetes incidence by 46% in diverse populations, even without sustained weight loss (3). As diabetes ...

7. cdc.gov cdc.gov/diabetes-prevention/index.html

National Diabetes Prevention Program The National Diabetes Prevention Program is building a nationwide network for its lifestyle change program, which is proven to cut type 2 diabetes risk in half.

8. withpower.com withpower.com/trial/phase-prediabetic-state-9-2022-ebfeb

NDPP-Flex for Prediabetes · Info for Participants It offers a flexible and personalized approach to help people set and achieve their own health goals, which can reduce the risk of developing type 2 diabetes.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8546276/

Patient-Centered Goal-Setting in the National Diabetes ... Compared with the standard NDPP, NDPP-Flex did not increase retention, weight loss, or physical activity, but resulted in greater glycemic improvement (0.2% ...

10. coveragetoolkit.org coveragetoolkit.org/about-national-dpp/ndpp-overview/

National Diabetes Prevention Program Overview The CDC DPRP standards require that at least 35% of a program's participants be diagnosed with prediabetes through blood testing (or have a ...