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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jan 4, 2023

Keywords

ClinConnect Summary

The NDPP-NextGen clinical trial is designed to help young women who are overweight or obese reduce their risks of obesity and diabetes, especially before and during pregnancy. The study will involve 360 women aged 18 to 39 who are not currently pregnant but plan to conceive within the next two years. Participants will be divided into two groups: one will take part in a special online program for a year that focuses on healthy living, while the other group will receive general information on maintaining health during pregnancy. The trial aims to see how this program affects blood sugar levels, weight gain during pregnancy, and the health of the baby at birth.

To be eligible for this study, women must be established patients at specific health centers, speak either English or Spanish, and have a body mass index (BMI) of 25 or higher. Participants will complete up to four visits during the study, where they’ll answer questions about their health, have their body size measured, and give blood samples. They will also weigh themselves weekly at home. This trial is a great opportunity for women looking to improve their health and the health of their future children.

Gender

FEMALE

Eligibility criteria

• 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)
• Exclusion Criteria:
• • 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 (e.g., polycystic ovarian syndrome)
• • Documented infertility or unsuccessfully trying to conceive for ≥12 months
• • Prior participation in the NDPP
• • History of bariatric surgery
• • Use of GLP-1s in last year
• • Currently receiving clinical obesity treatment