NDPP-NextGen for Diabetes Risk Reduction

Recruiting at 1 trial location

Overseen By Katherine A Sauder, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Pregnancy, Diabetes, Long-acting contraceptives, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 12 months

403 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new online program called NDPP-NextGen, designed to help young women improve their health before and during pregnancy. It focuses on reducing the risk of developing diabetes and managing weight through virtual classes on healthy eating and exercise. Women who are overweight, planning to become pregnant within two years, and are patients at specific health centers can participate. Participants will learn lifestyle changes that may benefit both their health and their baby's health.

As an unphased trial, this study offers a unique opportunity for participants to proactively enhance their health and their future baby's health through innovative lifestyle changes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using long-acting contraceptives and plan to continue for more than a year, you may not be eligible to participate.

What prior data suggests that the NDPP-NextGen is safe for young women in childbearing years?

Research has shown that the Diabetes Prevention Program (DPP) effectively reduces the risk of developing type 2 diabetes. Studies found that participants in the DPP Lifestyle Change Program lowered their diabetes risk by 58%. This program involves lifestyle changes such as healthier eating and regular exercise.

The NDPP-NextGen is an improved version of this program, designed specifically for young women who may have children in the future. Although the NDPP-NextGen is new, many have successfully participated in the original DPP without experiencing serious side effects from the lifestyle changes it promotes.

Overall, the success of the DPP suggests that similar programs, like the NDPP-NextGen, are safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about NDPP-NextGen because it offers a unique approach to reducing diabetes risk by focusing on lifestyle changes before pregnancy. Unlike standard care options that typically address diabetes risk through medication or post-diagnosis intervention, this program emphasizes prevention through online classes led by trained Lifestyle Coaches. These classes teach women how to eat healthy, be active, and manage weight, all while providing ongoing support via video-conferencing and motivational interviewing. This proactive and personalized approach could effectively lower diabetes risk, empowering women with the tools they need to maintain a healthy lifestyle before, during, and after pregnancy.

What evidence suggests that NDPP-NextGen is effective for diabetes risk reduction in young women?

Initial findings suggest that the National Diabetes Prevention Program (NDPP) effectively lowers the risk of diabetes. Studies have shown that participants lose an average of about 4% of their body weight, with younger adults and women losing around 2%. The program also significantly reduces the chance of developing diabetes in people with prediabetes. In this trial, participants in the Healthy Lifestyle group will engage with the NDPP-NextGen, an improved version of the program, expected to enhance maternal health and further reduce diabetes risk in women. Overall, the NDPP offers a promising way to manage weight and decrease the risk of diabetes. ^{6 7 8 9 10}

Who Is on the Research Team?

Katherine Sauder, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for women aged 18-39 at Denver Health who are overweight or obese, not currently pregnant but considering pregnancy within the next two years. It's open to those who may become pregnant soon, including those not actively trying but open to it. Women with non-gestational diabetes, certain medical conditions or procedures preventing pregnancy, current participation in NDPP, or long-term contraception use aren't eligible.

Inclusion Criteria

Interested in pregnancy within 24 months: High interest (actively trying to conceive), General interest (wanting to become pregnant in the foreseeable future), Neutral interest (not planning pregnancy or using contraception for religious reasons)

Established patient at Denver Health or Atrium Health Wake Forest Baptist

My BMI is 25 or higher (23 or higher if I am Asian).

Exclusion Criteria

Currently pregnant

Medical procedures or conditions that impede pregnancy

Long-acting contraceptives with plans to continue for >1 year (barrier & short-acting hormonal contraception permitted)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-session

Participants engage in a motivational pre-session to increase NDPP engagement, discussing diabetes risks and treatment options

1 week

1 visit (virtual)

Treatment

Participants attend the NDPP-NextGen online group class, initially meeting weekly for 6 months, then bi-monthly for 3 months, and monthly for the last 3 months

12 months

Weekly virtual classes for 6 months, bi-monthly for 3 months, monthly for 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including research visits at conception, mid-pregnancy, and delivery

Up to 24 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NDPP-NextGen

Trial Overview

The NDPP-NextGen program is being tested against usual care in young women at risk of obesity and diabetes before and during pregnancy. The study will compare pre-pregnancy blood sugar control and BMI changes as well as weight gain during pregnancy between the group receiving online classes on health management and a control group given health information packets.

How Is the Trial Designed?

Group I: Healthy Lifestyle Experimental Treatment 1 Intervention

Women in the Healthy Lifestyle group will be invited to attend the online NDPP-NextGen class which will cover how to eat healthy, be active, and lose weight before getting pregnant. The classes will be led by a trained Lifestyle Coach. Each class lasts about 1 hour. Classes initially meet about once a week (for the first 6 months), then twice a month (for the next 3 months), and then once a month (for the last 3 months). Classes will meet virtually through video-conference. Lifestyle coaches will also call participants in between classes to discuss how participants are doing, answer questions, and provide reminders for upcoming classes. Prior to the first class, women will also participate in a "pre-session" designed to increase NDPP engagement via discussion of diabetes risks and treatment options (i.e., clarify relevance) and motivational interviewing to resolve barriers.

Group II: Healthy Women Active Control 1 Intervention

Women in the Healthy Women group get a packet of information standardly given in OB clinics about how to be healthy before, during and after pregnancy.

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

Approved in United States as National Diabetes Prevention Program for:

• Type 2 diabetes prevention
• Weight management

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Incretin-based therapies, such as DPP-4 inhibitors and GLP-1 agonists, provide effective glycemic control for type 2 diabetes patients without the weight gain often seen with traditional treatments, making them a favorable option for many.

Clinical trial data suggest that these therapies are safe, showing no negative effects on cardiovascular health, and their integration into treatment plans can enhance options for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New therapeutic options: management strategies to optimize glycemic control. Freeman, JS.[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]

In a study of 776 adults with prediabetes, those who participated in in-person classroom-based programs showed greater retention, weight loss, and physical activity compared to other program types.

Regardless of the program format—whether in-person or online—all participants experienced health benefits, including improvements in blood pressure and self-rated health, indicating that the National Diabetes Prevention Program is effective across different delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uptake, retention, and outcomes of the National Diabetes Prevention Program by enrollee characteristics and program type. Herman, WH., Villatoro, C., Joiner, KL., et al.[2023]

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]

The Medicare Diabetes Prevention Program (MDPP) offers a pay-for-performance model to provide lifestyle interventions for Medicare beneficiaries with prediabetes, but there is a significant financial gap between the costs of delivering the program ($800 per participant) and the projected average reimbursement ($138.52).

The study highlights that low reimbursement rates may limit access to the MDPP, particularly for diverse and low-income populations, potentially exacerbating health disparities in diabetes prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Medicare Diabetes Prevention Coverage May Limit Beneficiary Access and Widen Health Disparities. Ritchie, ND., Gritz, RM.[2020]

In a study of 1,007 participants in the National Diabetes Prevention Program, individuals lost an average of 4% of their initial body weight, with about one-third achieving over 5% weight loss, indicating the program's overall efficacy in promoting weight loss.

After controlling for program attendance and physical activity, no significant disparities in weight loss outcomes were found among different demographic groups, although lower attendance and physical activity levels were noted in non-Hispanic Black and Hispanic participants, suggesting a need for targeted strategies to enhance their engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Disparities Among Hispanic and Underserved Participants, Colorado, 2015-2018. Clennin, MN., Maytag, A., Ellis, J., et al.[2021]

A study identified 73 community pharmacies recognized by the CDC for the National Diabetes Prevention Program (NDPP), with 42% of them completing a survey about their program delivery and challenges, particularly during the COVID-19 pandemic.

Despite the pandemic significantly impacting operations, 67% of these pharmacies continued to offer the NDPP, highlighting their commitment to diabetes prevention even under challenging circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of CDC-recognized community pharmacies providing the National Diabetes Prevention Program and impact of the COVID-19 pandemic on program delivery. Spence, R., Sisson, EM., Dixon, DL.[2022]

Incretin-based therapies, which help manage diabetes, show potential benefits like weight loss and reduced inflammation, but their long-term safety regarding cardiovascular events remains unclear due to insufficient human data.

While there are case reports linking incretin therapies to pancreatitis, larger studies do not support a strong association, and concerns about their link to cancer are still unresolved, highlighting the need for ongoing research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of incretin-based therapies--review of the scientific evidence. Drucker, DJ., Sherman, SI., Bergenstal, RM., et al.[2011]

In a study involving approximately 32,800 users of exenatide, there was a modestly higher incidence of claims for thyroid malignancies compared to users of metformin or glyburide, but this association was not significant when focusing on inpatient claims.

Exenatide use was not linked to an increased risk of benign thyroid neoplasms or pancreatic cancer, suggesting it may be a safe option regarding these specific cancer risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of health insurance claims for thyroid neoplasm and pancreatic malignancy in association with exenatide: signal refinement using active safety surveillance. Dore, DD., Seeger, JD., Chan, KA.[2021]

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]

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 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]

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