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:to assess effects of NDPP-NextGen on pre-pregnancy blood sugar and early pregnancy BMIto assess effects of NDPP-NextGen on weight gain and behavioral outcomes during pregnancyto explore effects of NDPP-NextGen on infant's percentage of fat tissue at birthAll 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 depressionBody size measurementsFasted 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.

Inclusion Criteria:Established patient at Denver HealthBiologically female (inclusive of all gender identities)Aged 18-39 yearsEnglish- or Spanish-speakingBMI ≥25 kg/m2 (≥23 kg/m2 if Asian race)Activities that lead to pregnancy in past 3 monthsInterested 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 pregnantNon-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 monthsPrior participation in the NDPP