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

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.

Conditions

• Overweight or Obesity

Interventions

BEHAVIORAL

NDPP-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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Katherine Sauder, PhD · Wake Forest University Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

39 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-04-08

Primary Completion

2027-05-31

Completion

2028-05-31

Countries

• United States

Study Locations