The OHSU Pregnancy Exercise & Nutrition (PEN) Program

Sponsor

Oregon Health and Science University (Other)

Overall Status

Completed

CT.gov ID

NCT01719406

Collaborator

(none)

Enrollment

Location

Arms

15.9

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Nov 1, 2012

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Achieving 30 minutes of daily exercise, four or more times each week [32 weeks]
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 [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

Pregnancy weight gain [20 weeks]
Assess pregnancy weight gain, in which excessive weight gain is a risk factor for gestational diabetes.
HemoglobinA1C [Each trimester and 12-weeks post delivery]
Assessing the average plasma glucose concentration over longer time periods.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

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.