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.
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
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
Parallel
NDPP-NextGen
BehavioralNDPP-NextGen will incorporate content on preconception/prenatal health into standard NDPP. Participants will be encouraged to make sustainable improvements in diet and activity, but without pre-set goals to better accommodate diverse, low-income populations. Upon pregnancy, recommendations will adjust to support appropriate GWG, breastfeeding, and postpartum weight loss. We will provide education on diet and activity during pregnancy/postpartum, including sufficient energy intake and exercise safety to support the growing fetus. NDPP-NextGen will include 3 strategies to better engage young women. (1) "Pre-sessions" to increase knowledge of diabetes risks, self-efficacy, and readiness to change using motivational interviewing techniques. (2) Delivering classes remotely (via phone- and video-conference) to facilitate participation regardless of inclement weather, dependent care, illness, transportation, etc. (3) Offering classes specially for young women to increase personal relevance.
BMI in early pregnancy
Height and weight will be measured and combined to report BMI at the post-conception research visit occurring at 6-8 weeks gestation.
Glycemia in early pregnancy
Fasting glucose
Peri-conceptional BMI
BMI at conception will be collected with cellular-enabled scales (BodyTrace®) that facilitate weekly at-home measurement to obtain weight closer to conception. Scales automatically transfer weights to a HIPAA-compliant database that is accessible only by the research team. Research staff will monitor for ≥1 transmitted weight each week, and provide prompts and assistance as needed. Investigators will average the two weights from before/after estimated date of conception to calculate approximate peri-conceptional BMI.
Rate and timing of gestational weight gain (GWG)
Primary method of collection will be through the use of home cellular scale weights. We will also abstract all weights from prenatal medical records as a secondary method to assess GWG. GWG will be analyzed as the difference from conception to delivery and gain within each trimester, adjusting for BMI at conception. We will also analyze GWG trajectories using linear mixed models with repeated measures drawn from the home scales and/or prenatal clinical weights. We will then classify women as having inadequate, appropriate, or excessive GWG based on BMI category, and analyze using logistic regression, again adjusting for BMI at conception.
A1C in early pregnancy
Fasted blood draw
Glycemic status in early pregnancy
Fasted blood draw to classify as normoglycemia, pre-diabetes, or type 2 diabetes at conception per American Diabetes Association definitions
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
