NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks
Wake Forest University Health Sciences
Summary
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.
Description
Intrauterine exposure to maternal overweight/obesity and diabetes transmits risks to offspring, triggering a disease cycle across generations. Over half of US women have overweight or obesity at conception and \~10% of pregnancies are affected by diabetes, exposing nearly 2 million infants each year. Prenatal lifestyle interventions are well-studied, yet begin too late to impact the critical period of conception and early pregnancy. Starting interventions before conception may be key to halting the disease cycle. However, prior research is limited, often lacks offspring outcomes (especially se…
Eligibility
- Age range
- 18–39 years
- Sex
- Female
- Healthy volunteers
- Yes
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)…
Interventions
- BehavioralNDPP-NextGen
NDPP-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.
Location
- Wake Forest University Health SciencesWinston-Salem, North Carolina