Actively Recruiting

Phase Not Applicable
Age: 18Years - 39Years
FEMALE
Healthy Volunteers
NCT05674799

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

Led by Wake Forest University Health Sciences · Updated on 2026-02-27

403

Participants Needed

1

Research Sites

268 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial 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: 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 39Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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, general, or neutral interest
Not Eligible

You will not qualify if you...

  • Currently pregnant
  • Non-gestational diabetes (type 1 or type 2)
  • Long-acting contraceptives with plans to continue for more than 1 year (barrier and short-acting hormonal contraception allowed)
  • Medical procedures or conditions that prevent pregnancy (e.g., tubal ligation, hysterectomy)
  • Documented infertility or trying to conceive without success for 12 months or more
  • Prior participation in the NDPP
  • History of bariatric surgery
  • Use of GLP-1 medications in the last year
  • Currently receiving clinical obesity treatment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

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Research Team

K

Katherine A Sauder, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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