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NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks
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:
🦠 Overweight or Obesity
🗓️ Study Start (Actual) 8 April 2023
🗓️ Primary Completion (Estimated) 31 May 2027
✅ Study Completion (Estimated) 31 May 2028
👥 Enrollment (Estimated) 403
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Winston-Salem, North Carolina, United States

📋 Eligibility Criteria

Description

    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:
    • 1. High interest (actively trying to conceive)
    • 2. General interest (not actively trying but wanting to become pregnant in the foreseeable future)
    • 3. 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 (e.g., polycystic ovarian syndrome)
    • * Documented infertility or unsuccessfully trying to conceive for ≥12 months
    • * Prior participation in the NDPP
Ages Eligible for Study: 18 Years to 39 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 November 2022
  • First Submitted that Met QC Criteria 4 January 2023
  • First Posted 6 January 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 May 2024
  • Last Update Posted 3 May 2024
  • Last Verified March 2024
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