The OHSU Pregnancy Exercise & Nutrition (PEN) Program

Not Applicable

Completed

• Conditions: Gestational Diabetes
• Interventions: Behavioral: Intervention, behavioral lifestyle education

• Registration Number: NCT01719406
• Lead Sponsor: Oregon Health and Science University

Brief Summary

Personal behaviors can influence development of Gestational Diabetes Mellitus (GDM), a condition that can adversely affect the pregnant woman, her developing fetus and future events for both. To reduce GDM risk, we will develop and implement an in-person team and web-based nutrition and exercise program for women, beginning in their first trimester. A scripted, peer-led, 20-week educational program, tailored for pregnant women working in teams (5 women/team), will be developed and implemented among pregnant employees and/or their spouses. Each weekly thirty minute session will focus on achieving 30-minutes of moderate daily physical activity with nutrition targets of five servings of fruits and vegetables, 3 servings of whole grains and lower fat food choices. Diet, exercise and lab assessments will occur before enrollment during the first trimester, each subsequent trimester and 12 weeks after delivery. In addition to exercise and diet survey results, we will assess fasting glucose, insulin, hemoglobin A1C levels, pregnancy weight gain, blood pressure, lipid and lipoprotein levels, pedometer records, weekly accelerometer data, each trimester and at 12 weeks post delivery, as well as gestational birth age, Apgar score, delivery mode and infant birth weight, and weekly health thermometer self-ratings during the assessment period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-30
• Study Start: 2012-11
• Study First Posted: 2012-11-01
• Status Verified: 2013-01
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Healthy first trimester pregnant women -

Exclusion Criteria

hypertension, diabetes, known cardiopulmonary disease; orthopedic problems or other conditions that would prevent regular physical activity.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention, behavioral lifestyle education	Intervention, behavioral lifestyle education	Pregnant women will participate in 20 educational sessions designed to promote daily exercise, vegetable and fruit intake, maintain a diet that is relatively lower in fat and rich in whole grains.

Primary Outcome Measures

Name	Time	Method
Achieving 30 minutes of daily exercise, four or more times each week	32 weeks	Assessment of daily exercise (in minutes) during pregnancy and 12 weeks post pregnancy for the duration of the study.

Secondary Outcome Measures

Name	Time	Method
Eating 5 or more servings of vegetables and/or fruits each day	32 weeks of the study	Women will self-assess the number of servings of vegetables and fruits each day throughout the study.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States