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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 39 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 64 days
  • Procedures mentioned: Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Questionnaires about health, diet, activity, smoking, self-confidence, and depression 2."
  • "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."
  • "For example, young women attended the 12-month NDPP for 64 days longer after receiving a pre-session, with 2.0 kg/m2 lower preconception BMI and 0.4% lower A1c in early pregnancy, than controls."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a 12-month online diabetes prevention program made for young women who may become pregnant. It is for women ages 18–39 with overweight or obesity who are not pregnant now but may become pregnant within 2 years. Researchers will compare the program with a health information packet and study blood sugar, weight, health habits, and babies’ body fat at birth.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Already a patient at Denver Health or Atrium Health Wake Forest Baptist.
  • Biologically female; all gender identities are welcome.
  • Age 18–39.
  • Speak English or Spanish.
  • Have a BMI of at least 25, or at least 23 if Asian. BMI is a measure based on height and weight.
  • Have taken part in activities that could lead to pregnancy in the past 3 months.
  • May become pregnant within 2 years: actively trying, wanting pregnancy in the future, or neither planning pregnancy nor using birth control for religious reasons.

Who can't join

  • Pregnant now.
  • Have type 1 or type 2 diabetes, rather than diabetes only during pregnancy.
  • Use an IUD, birth control implant, or birth control shot and plan to continue for more than 1 year.
  • Have had a procedure or have a health condition that makes pregnancy difficult or impossible.
  • Have a record of infertility, or have tried to become pregnant for at least 12 months without success.
  • Have taken part in the National Diabetes Prevention Program before.
  • Have had weight-loss surgery or are getting medical treatment for obesity now.
  • Have used a GLP-1 medicine, a type used for diabetes or weight loss, in the past year.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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: 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 * 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

Study sites (1)

NC