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NCT05674799
NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks
NA trial testing NDPP-NextGen in Overweight or Obesity in 403 participants. Currently enrolling.
31 May 2027
Quick facts
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 403 |
| Start date | 8 April 2023 |
| Primary completion | 31 May 2027 |
| Estimated completion | 31 May 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- NDPP-NextGen
Conditions studied
- Overweight or Obesity — all drugs for Overweight or Obesity →
Sponsor
Wake Forest University Health Sciences
Who can join
Adults 18 to 39, female only, with Overweight or Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A pre-conception clinical trial to reduce intergenerational obesity and diabetes risks: The NDPP-NextGen trial protocol.
Sauder KA, Gamalski K, DeRoeck J, Vasquez FP, et al · · 2023 · cited 3× · PMID 37516162 · DOI 10.1016/j.cct.2023.107305
Verify or expand the search:
- PubMed search for NCT05674799
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Wake Forest University Health Sciences trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05674799 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
- Last refreshed: 27 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05674799.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing