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临床试验/NCT01719406
NCT01719406已完成不适用

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

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Achieving 30 minutes of daily exercise, four or more times each week

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy first trimester pregnant women -

排除标准

  • hypertension, diabetes, known cardiopulmonary disease; orthopedic problems or other conditions that would prevent regular physical activity.

结局指标

主要结局

Achieving 30 minutes of daily exercise, four or more times each week

时间窗: 32 weeks

Assessment of daily exercise (in minutes) during pregnancy and 12 weeks post pregnancy for the duration of the study.

次要结局

  • Eating 5 or more servings of vegetables and/or fruits each day(32 weeks of the study)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Linn Goldberg

Professor of Medicine

Oregon Health and Science University

研究点 (2)

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The OHSU Pregnancy Exercise & Nutrition (PEN) Program | 临床试验