NDPP-Flex for Prediabetes

(NDPP-Flex Trial)

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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares a personalized diabetes prevention program (NDPP-Flex) to the standard program in 200 adults with prediabetes. NDPP-Flex sets individual health goals to better manage blood sugar levels. The study aims to see if NDPP-Flex is more effective, especially for diverse and underserved groups. The National Diabetes Prevention Program (NDPP) aims to reduce diabetes incidence through modest weight loss.

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 data supports the idea that NDPP-Flex for Prediabetes is an effective treatment?

The available research shows that NDPP-Flex, a version of the National Diabetes Prevention Program, is effective in helping people with prediabetes. For example, a study found that when the program was delivered through a rural community service using Zoom, 44% of participants achieved a weight loss of 5% or more, which is a key goal for reducing diabetes risk. This was significantly better than another group using Facebook, where only 7% achieved the same weight loss. Additionally, the program helped many participants reach the goal of 150 minutes of physical activity per week, which is important for preventing diabetes. ^{1 2 3 4 5}

What data supports the effectiveness of the NDPP-Flex treatment for prediabetes?

The NDPP-Flex treatment, an adaptation of the National Diabetes Prevention Program, shows promise in helping individuals set and achieve personalized goals to reduce diabetes risk. A study found that a similar program delivered in rural areas led to significant weight loss and increased physical activity, which are key factors in preventing diabetes. ^{1 2 3 4 5}

What safety data is available for NDPP-Flex for prediabetes?

The provided research does not explicitly mention safety data for NDPP-Flex or its other names. The studies focus on the feasibility, effectiveness, and delivery methods of the National Diabetes Prevention Program (NDPP) and its adaptations, such as NDPP-Flex. However, they do not provide specific safety data or report any adverse effects related to the program. ^{1 2 3 4 6}

Is the NDPP-Flex program safe for humans?

The available research on the National Diabetes Prevention Program (NDPP) and its adaptations, including NDPP-Flex, does not report any safety concerns for participants. The studies focus on behavior change and lifestyle interventions, which are generally considered safe for human participants. ^{1 2 3 4 6}

Is NDPP-Flex a promising treatment for prediabetes?

Yes, NDPP-Flex is a promising treatment for prediabetes. 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. The program has shown potential in helping people lose weight and increase physical activity, which are important steps in preventing diabetes. ^{1 2 3 4 6}

How is the NDPP-Flex treatment different from other treatments for prediabetes?

NDPP-Flex is unique because it offers a more personalized approach to preventing diabetes by allowing patients to set and adjust their own goals, such as weight loss and physical activity, making it more adaptable to individual needs compared to standard programs. ^{1 2 3 4 6}

Research Team

Rocio Pereira, MD

Principal Investigator

Denver Health

Eligibility Criteria

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

I am 18 years old or older.

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.

Exclusion Criteria

Currently pregnant

I have diabetes (type 1 or 2).

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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]

References

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

Patient-Centered Goal-Setting in the National Diabetes Prevention Program: A Pilot Study. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Preliminary Findings of the Delivery of the National Diabetes Prevention Program via a Mobile Application. [2018]

3. United States 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. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Comparative Effectiveness for the Delivery of the National Diabetes Prevention Program through Cooperative Extension in Rural Communities. [2022]

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

Implementing electronic health record-based National Diabetes Prevention Program referrals in a rural county. [2022]

6. England 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. [2023]