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The OHSU Pregnancy Exercise & Nutrition (PEN) Program

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01719406
Acronym
PEN
Enrollment
30
Registered
2012-11-01
Start date
2012-11-30
Completion date
2014-03-31
Last updated
2014-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

Keywords

Gestational diabetes, Exercise, Diet, Fruits, Vegetables, Whole grains, pregnancy weight

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.

Interventions

BEHAVIORALIntervention, behavioral lifestyle education

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

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
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. \-

Design outcomes

Primary

MeasureTime frameDescription
Achieving 30 minutes of daily exercise, four or more times each week32 weeksAssessment of daily exercise (in minutes) during pregnancy and 12 weeks post pregnancy for the duration of the study.

Secondary

MeasureTime frameDescription
Eating 5 or more servings of vegetables and/or fruits each day32 weeks of the studyWomen will self-assess the number of servings of vegetables and fruits each day throughout the study.

Other

MeasureTime frameDescription
Pregnancy weight gain20 weeksAssess pregnancy weight gain, in which excessive weight gain is a risk factor for gestational diabetes.
HemoglobinA1CEach trimester and 12-weeks post deliveryAssessing the average plasma glucose concentration over longer time periods.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026