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OpenTrials
Completed

NCT Number: NCT01719406

The OHSU Pregnancy Exercise & Nutrition (PEN) Program

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

Intervention, behavioral lifestyle education

Behavioral

Twenty interactive weekly sessions that are scripted curriculum and peer led.

Other names: Lifestyle, Nutrition, Exercise, Stress management

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. Pregnancy weight gain

    Time frame: 20 weeks

    Assess pregnancy weight gain, in which excessive weight gain is a risk factor for gestational diabetes.

  2. HemoglobinA1C

    Time frame: Each trimester and 12-weeks post delivery

    Assessing the average plasma glucose concentration over longer time periods.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Randomized Control Pilot of a Behavior-based Exercise and Diet Intervention to Reduce Risk Factors for Gestational Diabetes Among Otherwise Healthy Pregnant Women.

Acronym: PEN

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 1, 2012
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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