The OHSU Pregnancy Exercise & Nutrition (PEN) Program (PEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01719406
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : October 15, 2014
Information provided by (Responsible Party):
Linn Goldberg, 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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Behavioral: Intervention, behavioral lifestyle education Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Control Pilot of a Behavior-based Exercise and Diet Intervention to Reduce Risk Factors for Gestational Diabetes Among Otherwise Healthy Pregnant Women.
Study Start Date : November 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Behavioral: Intervention, behavioral lifestyle education
Twenty interactive weekly sessions that are scripted curriculum and peer led.
Other Names:
  • Lifestyle
  • Nutrition
  • Exercise
  • Stress management

No Intervention: Control
Standard medical care

Primary Outcome Measures :
  1. Achieving 30 minutes of daily exercise, four or more times each week [ Time Frame: 32 weeks ]
    Assessment of daily exercise (in minutes) during pregnancy and 12 weeks post pregnancy for the duration of the study.

Secondary Outcome Measures :
  1. Eating 5 or more servings of vegetables and/or fruits each day [ Time Frame: 32 weeks of the study ]
    Women will self-assess the number of servings of vegetables and fruits each day throughout the study.

Other Outcome Measures:
  1. Pregnancy weight gain [ Time Frame: 20 weeks ]
    Assess pregnancy weight gain, in which excessive weight gain is a risk factor for gestational diabetes.

  2. HemoglobinA1C [ Time Frame: Each trimester and 12-weeks post delivery ]
    Assessing the average plasma glucose concentration over longer time periods.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01719406

United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University

Responsible Party: Linn Goldberg, Professor of Medicine, Oregon Health and Science University Identifier: NCT01719406     History of Changes
Other Study ID Numbers: eIRB # 8895
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: January 2013

Keywords provided by Linn Goldberg, Oregon Health and Science University:
Gestational diabetes
Whole grains
pregnancy weight

Additional relevant MeSH terms:
Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases