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.|
|ClinicalTrials.gov Identifier: NCT01719406|
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : October 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes||Behavioral: Intervention, behavioral lifestyle education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
No Intervention: Control
Standard medical care
- 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.
- 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.
- Pregnancy weight gain [ Time Frame: 20 weeks ]Assess pregnancy weight gain, in which excessive weight gain is a risk factor for gestational diabetes.
- HemoglobinA1C [ Time Frame: Each trimester and 12-weeks post delivery ]Assessing the average plasma glucose concentration over longer time periods.
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 ClinicalTrials.gov identifier (NCT number): NCT01719406
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|