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

Trial Summary

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 data supports the effectiveness of the NDPP-NextGen treatment for diabetes risk reduction?

The National Diabetes Prevention Program (NDPP) has been shown to help reduce the risk of developing type 2 diabetes by promoting healthy lifestyle changes, such as weight loss and increased physical activity. Studies have found that adapting the program to be more flexible and patient-centered can improve its effectiveness, and delivering it through mobile applications can make it more accessible. ^{1 2 3 4 5}

Is NDPP-NextGen safe for humans?

Incretin-based therapies, which may be similar to NDPP-NextGen, have been shown to be generally safe in humans. They do not seem to increase the risk of major cardiovascular events and are associated with weight-neutral or weight-reducing effects. ^{6 7 8 9 10}

How is the NDPP-NextGen treatment different from other diabetes prevention treatments?

The NDPP-NextGen treatment is unique because it focuses on lifestyle changes to prevent type 2 diabetes, rather than using medication. It involves a yearlong program that includes support from community organizations and can be delivered in-person or through a mobile app, making it accessible and adaptable to different needs. ^{1 3 4 11 12}

What is the purpose of this trial?

The goal of this clinical trial is to test an enhanced version of the National Diabetes Prevention Program (NDPP-NextGen) that is tailored to young women in childbearing years. The investigators will recruit 360 women aged 18-39 years with overweight/obesity who are not currently pregnant, but likely to conceive within 24 months. Women will be randomized to NDPP-NextGen or a usual care control group. The NDPP-NextGen group will participate in the adapted NDPP online group class across 12 months, and the control group will get a packet of information about how to be healthy before, during and after pregnancy. The main goals of the study are: 1. to assess effects of NDPP-NextGen on pre-pregnancy blood sugar and early pregnancy BMI 2. to assess effects of NDPP-NextGen on weight gain and behavioral outcomes during pregnancy 3. to explore effects of NDPP-NextGen on infant's percentage of fat tissue at birth All participants will complete up to 4 research visits: baseline, conception, mid-pregnancy, and delivery. These visits will include: 1. Questionnaires about health, diet, activity, smoking, self-confidence, and depression 2. Body size measurements 3. Fasted blood draws Participants will also be asked to weigh themselves weekly using home scales that are connected to the research database. At the delivery visit, investigators will measure the baby's body size and collect a cord blood sample.

Research Team

Katherine Sauder, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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, 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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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

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

New Medicare Diabetes Prevention Coverage May Limit Beneficiary Access and Widen Health Disparities. [2020]

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

Weight Loss Disparities Among Hispanic and Underserved Participants, Colorado, 2015-2018. [2021]

6. England pubmed.ncbi.nlm.nih.gov

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

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

The safety of incretin-based therapies--review of the scientific evidence. [2011]

8. 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]

9. England 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. [2021]

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

New therapeutic options: management strategies to optimize glycemic control. [2022]

11. Ireland pubmed.ncbi.nlm.nih.gov

Uptake, retention, and outcomes of the National Diabetes Prevention Program by enrollee characteristics and program type. [2023]

12. United States 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. [2022]