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

Recruiting now · Not applicable

Conditions studied: Overweight or Obesity

In brief

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.

Key facts

Study ID

NCT05674799

Run by

Wake Forest University Health Sciences

People needed

403

Starts

2023-04-08

Expected to finish

2028-05-31

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older, up to 39. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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