NDPP-NextGen: Reducing Obesity and Diabetes Risks Across Generations

This study is testing an updated version of the National Diabetes Prevention Program called NDPP-NextGen. This program is designed for young women who are overweight or have obesity and are planning to become pregnant. The goal is to see if NDPP-NextGen can help improve blood sugar levels before pregnancy and reduce body mass index (BMI) in early pregnancy. This could help prevent health problems for both mothers and their children. You might be able to join if you are a woman between 18 and 39 years old, have a BMI of 25 or higher (or 23 if you are of Asian descent), are English or Spanish-speaking, and are interested in becoming pregnant within the next two years. The study aims to enroll 403 participants, but the current recruitment status is unclear.

Study design
This is an interventional study where 403 women will be randomly assigned to either receive the NDPP-NextGen program or a packet of information about healthy pregnancy.
What's involved
Participants in the NDPP-NextGen group will take part in an online group class over 12 months. The control group will receive an information packet.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, BMI in early pregnancy, is measured at 6-8 weeks gestation.

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NCT05674799

NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks

Recruiting
NAAges 18–39InterventionalPrevention
Wake Forest University Health Sciences
~403 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:NDPP-NextGen

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
BMI in early pregnancy
Measured over 6-8 weeks gestation
Overweight or Obesity
1 sites across 1 states
North Carolina1
  • Katherine Sauder, PhD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

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Eligibility criteria

Inclusion

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:

Exclusion

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
  • BMI in early pregnancy6-8 weeks gestation

    Height and weight will be measured and combined to report BMI at the post-conception research visit occurring at 6-8 weeks gestation.