The OHSU Pregnancy Exercise & Nutrition (PEN) Program

NCT ID: NCT01719406

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-03-31

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.

Conditions

Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intervention, behavioral lifestyle education

Intervention Type: BEHAVIORAL

Twenty interactive weekly sessions that are scripted curriculum and peer led.

Control

Standard medical care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention, behavioral lifestyle education

Twenty interactive weekly sessions that are scripted curriculum and peer led.

Intervention Type: BEHAVIORAL

Other Intervention Names

Lifestyle; Nutrition; Exercise; Stress management

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Linn Goldberg

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

eIRB # 8895

Identifier Type: -

Identifier Source: org_study_id