NCT05674799Recruiting
NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 403 (estimated)
- First submitted
- 21 Nov 2022
- Start date
- 8 Apr 2023
- Primary completion date
- 31 May 2027
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Obesity
- NCT number
- NCT05674799
What you commit to
- Study type: Interventional
- Planned participants: 403
- From 8 Apr 2023 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Prior participation in the NDPP
- Currently receiving clinical obesity treatment
Other illness
- Non-gestational diabetes (type 1, type 2)
- Medical procedures (e.g., tubal ligation, hysterectomy) or conditions that impede pregnancy
- History of bariatric surgery
Other
- Currently pregnant
- Documented infertility or unsuccessfully trying to conceive for ≥12 months
- Use of GLP-1s in last year
Who the study is looking for
- 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)
Age in the registry: 18 years to 39 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.