The OHSU Pregnancy Exercise & Nutrition (PEN) Program

Gestational Diabetes Clinical Trial

— PEN  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719406
• Other study ID #: eIRB # 8895
• Status: Completed
• Phase: N/A
• First received: October 29, 2012
• Last updated: October 14, 2014
• Start date: November 2012
• Est. completion date: March 2014

Study information

• Verified date: January 2013
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Behavioral:
• Intervention, behavioral lifestyle education
Twenty interactive weekly sessions that are scripted curriculum and peer led.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pregnancy weight gain	Assess pregnancy weight gain, in which excessive weight gain is a risk factor for gestational diabetes.	20 weeks	No
Other	HemoglobinA1C	Assessing the average plasma glucose concentration over longer time periods.	Each trimester and 12-weeks post delivery	No
Primary	Achieving 30 minutes of daily exercise, four or more times each week	Assessment of daily exercise (in minutes) during pregnancy and 12 weeks post pregnancy for the duration of the study.	32 weeks	No
Secondary	Eating 5 or more servings of vegetables and/or fruits each day	Women will self-assess the number of servings of vegetables and fruits each day throughout the study.	32 weeks of the study	No