The OHSU Pregnancy Exercise and Nutrition (PEN) Program
Clinical Trial Seeking Participants
IRB 8895 (PI: PI: Linn Goldberg, MD)
The Division of Health Promotion and Sports Medicine, Department of Medicine is participating in a study to learn more about reducing and preventing gestational diabetes. The study sponsor is The OHSU Moore Institute.
Trial Status:
Open to Enrollment
Why is this study being done?
This proposal will assess the feasibility and pilot an intervention designed to reduce the risk of gestational diabetes mellitus, by improving nutrition and physical activity practices among women, beginning in their first trimester. Healthy women who are OHSU employees or spouses of employees in their first trimester of pregnancy will be recruited. Intervention participants will be engaged in an interactive in-person, scripted curriculum over twenty weeks (once/week), and an interactive website. This intervention is based on OHSU’s 12-week Healthy Team Healthy U worksite wellness program.
The purpose of this study is to:
The primary goal of this study is to implement and evaluate the newly developed 20-session team and web-based behavior education program among three teams (five women/team) of pregnant women, initiated during their first trimester, focusing on healthy nutrition, stress reduction, and physical activity. Primary outcomes to be assessed during each trimester and 12-weeks post-delivery will include dietary intake of fruit and vegetable servings and whole grains, daily physical activity, and assessments of weight gained during pregnancy, glucose, insulin, hemoglobin A1C, lipid and lipoprotein levels, vitamin D levels, and parameters of newborn health.
Who is eligible to participate?
Women between the ages of 18 and 45 who:
- Are pregnant in their first trimester
- Are OHSU employees or spouses of employees
- Are in good general health
What is the compensation for this study?
All participants will be compensated $200 for data completion. Those randomized to the intervention group will receive 5-months of paid gym membership. Those randomized to the intervention group who are OHSU benefit eligible employees will receive the compensation for completion of Healthy TEAM Healthy U for insurance premium reduction and a cash incentive of up to $125.
Whom do I contact for more information?
To find out more information and to learn if you are qualified to participate, email Maggie McLain at mclainma@ohsu.edu or call her at 971-404-6827.
