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NCT01719406 · ClinicalTrials.gov registry record · NA
The OHSU Pregnancy Exercise & Nutrition (PEN) Program
A NA study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT01719406: Completed NA study, sponsored by Oregon Health and Science University.
NCT01719406 is a NA study that has completed, run by Oregon Health and Science University. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01719406, a NA study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
Assessment of daily exercise (in minutes) during pregnancy and 12 weeks post pregnancy for the duration of the study.
Interventions
- BEHAVIORAL Intervention, behavioral lifestyle education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-11 |
| Est. Completion | 2014-03 |
| Phase | NA |
What the finished NCT01719406 record still lists
NCT01719406 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Intervention, behavioral lifestyle education is the first listed.
NCT01719406 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01719406 about?
NCT01719406 is a clinical study titled "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 pro...
What is the current status of trial NCT01719406?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2012-11. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01719406?
The interventions under investigation include: Intervention, behavioral lifestyle education (BEHAVIORAL).
Who is sponsoring clinical trial NCT01719406?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01719406's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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