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

Wake Forest University Health Sciences · with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT05674799

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–39 · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
403
US sites recruiting
1
Study start
April 8, 2023
Record last updated
February 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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. 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

  • to assess effects of NDPP-NextGen on pre-pregnancy blood sugar and early pregnancy BMI
  • to assess effects of NDPP-NextGen on weight gain and behavioral outcomes during pregnancy
  • 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:

  • Questionnaires about health, diet, activity, smoking, self-confidence, and depression
  • Body size measurements
  • 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.

Being studied: NDPP-NextGen

Conditions: Overweight or Obesity

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Wake Forest University Health Sciences

    Winston-Salem, NC 27157

    Site contact: Katherine A Sauder, PhD · 336-716-1280 · Katherine.Sauder@advocatehealth.org

Study contacts (from the official record)

  • Katherine A Sauder, PhD · 336-716-1280 · Katherine.Sauder@advocatehealth.org
All weight loss studies in North Carolina →
NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity… (NCT05674799) | Bored Studies