403 Participants Needed

NDPP-NextGen for Diabetes Risk Reduction

Recruiting at 1 trial location
SC
KA
Overseen ByKatherine A Sauder, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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.12345

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.678910

Who Is on the Research Team?

KS

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).
See 2 more

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)
See 3 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Healthy LifestyleExperimental Treatment1 Intervention
Group II: Healthy WomenActive Control1 Intervention

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

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as National Diabetes Prevention Program for:

Find a Clinic Near You

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.
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.
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 formatโ€”whether in-person or onlineโ€”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.
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]

Citations

Effectiveness of the National Diabetes Prevention Program ...Outcomes have been well-documented for most participants; e.g., ~4% weight loss overall; ~2% weight loss for younger adults, women, racial and ethnic minority ...
The US National Diabetes Prevention Program (NDPP ...The absolute risk difference of 2.8% translates to a number needed to treat of 36 people for 2 years to prevent one case of diabetes. Past ...
A pre-conception clinical trial to reduce intergenerational ...This clinical trial will evaluate an intervention model (NDPP-NextGen) with potential to improve maternal health among the >50% of US females with overweight/ ...
NDPP-NextGen for Diabetes Risk ReductionThe NHS Diabetes Prevention Programme (NDPP) significantly reduced the conversion rate from nondiabetic hyperglycaemia (NDH) to type 2 diabetes mellitus (T2DM), ...
What Is the National DPP? | National Diabetes Prevention ...Results from the study showed that this structured lifestyle change programโ€”in which participants achieved weight loss of 5 to 7 percent of ...
Diabetes Prevention Program (DPP) - NIDDKAfter about 3 years, the DPP showed that participants in the DPP Lifestyle Change Program lowered their chances of developing type 2 diabetes by 58 percent ...
NIDDK's Journey Into the Prevention of Type 2 Diabetes and ...After mean 2.8 years, ILS reduced diabetes risk by 58% and metformin by 31%, leading to study termination ahead of schedule due to demonstrated ...
Retention and outcomes of National Diabetes Prevention ...Aims: To evaluate retention and outcomes of insured adults with prediabetes who enrolled or did not enroll in National Diabetes Prevention Programs (NDPPs).
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 ...
New Data from Diabetes Prevention Program Outcomes ...The DPP demonstrated lifestyle intervention, aimed at achieving weight loss, and metformin treatment reduced the risk of T2D development by 58% and 31%, ...
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