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