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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 39
Healthy Volunteers: t
View:

• 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:

‣ 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)

Locations
United States
North Carolina
Wake Forest University Health Sciences
RECRUITING
Winston-salem
Contact Information
Primary
Katherine A Sauder, PhD
ksauder@wakehealth.edu
336-716-1280
Time Frame
Start Date: 2023-04-08
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 403
Treatments
Experimental: Healthy Lifestyle
Women in the Healthy Lifestyle group will be invited to attend the online NDPP-NextGen class which will cover how to eat healthy, be active, and lose weight before getting pregnant. The classes will be led by a trained Lifestyle Coach. Each class lasts about 1 hour. Classes initially meet about once a week (for the first 6 months), then twice a month (for the next 3 months), and then once a month (for the last 3 months). Classes will meet virtually through video-conference. Lifestyle coaches will also call participants in between classes to discuss how participants are doing, answer questions, and provide reminders for upcoming classes. Prior to the first class, women will also participate in a pre-session designed to increase NDPP engagement via discussion of diabetes risks and treatment options (i.e., clarify relevance) and motivational interviewing to resolve barriers.
No_intervention: Healthy Women
Women in the Healthy Women group get a packet of information standardly given in OB clinics about how to be healthy before, during and after pregnancy.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov