NCT05674799 · Wake Forest University Health Sciences
NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Established patient at Denver Health or Atrium Health Wake Forest Baptist
- Biologically female (inclusive of all gender identities)
- Aged 18-39 years
- English- or Spanish-speaking
- BMI ≥25 kg/m2 (≥23 kg/m2 if Asian race)
- Activities that lead to pregnancy in past 3 months
- Interested in pregnancy within 24 months, including:
- High interest (actively trying to conceive)
- General interest (not actively trying but wanting to become pregnant in the foreseeable future)
- Neutral interest (not planning pregnancy or using contraception for religious reasons)
Exclusion criteria
- Currently pregnant
- Non-gestational diabetes (type 1, type 2)
- Long-acting contraceptives (intrauterine device, implant, injection) with plans to continue for \>1 year (barrier \& short-acting hormonal contraception permitted given ease of discontinuing to facilitate pregnancy)
- Medical procedures (e.g., tubal ligation, hysterectomy) or conditions that impede pregnancy
- Documented infertility or unsuccessfully trying to conceive for ≥12 months
- Prior participation in the NDPP
- History of bariatric surgery
- Use of GLP-1s in last year
- Currently receiving clinical obesity treatment
Where
- Winston-Salem, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations