Text Size

The OHSU Pregnancy Exercise & Nutrition (PEN) Program

This study is currently recruiting participants.
Verified January 2013 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
Linn Goldberg, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01719406
First received: October 29, 2012
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Gestational Diabetes
 Behavioral: Intervention, behavioral lifestyle education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Achieving 30 minutes of daily exercise, four or more times each week [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    Assessment of daily exercise (in minutes) during pregnancy and 12 weeks post pregnancy for the duration of the study.


Secondary Outcome Measures:
  • Eating 5 or more servings of vegetables and/or fruits each day [ Time Frame: 32 weeks of the study ] [ Designated as safety issue: No ]
    Women will self-assess the number of servings of vegetables and fruits each day throughout the study.


Other Outcome Measures:
  • Pregnancy weight gain [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assessing the average plasma glucose concentration over longer time periods.


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719406

Contacts
Contact: Linn Goldberg, M.D. 503-494-3861 goldberl@ohsu.edu
Contact: Esther L Moe, Ph.D. 503-494-8051 moe@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Linn Goldberg, MD     503-494-6559     goldberl@ohsu.edu    
Contact: Esther L Moe, Ph.D.     503-494-5084     moe@ohsu.edu    
Sub-Investigator: Esther L Moe, Ph.D., MPH            
Sub-Investigator: Maggie McLain, MPH            
Sub-Investigator: Diane L Elliot, M.D.            
Sub-Investigator: Diane Stadler, Ph.D.            
Sub-Investigator: Jessica Voge, M.D.            
Sponsors and Collaborators
Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Linn Goldberg, Professor of Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01719406     History of Changes
Other Study ID Numbers: eIRB # 8895
Study First Received: October 29, 2012
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Gestational diabetes
Exercise
Diet
Fruits
 Vegetables
Whole grains
pregnancy weight

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

ClinicalTrials.gov processed this record on May 16, 2013