跳至主要内容
临床试验/NCT01489163
NCT01489163已完成不适用

Translational Diabetes Prevention in GDM

Kaiser Permanente1 个研究点 分布在 1 个国家目标入组 352 人开始时间: 2011年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
352
试验地点
1
主要终点
postpartum body weight

研究概览

简要总结

The purpose of this research study is to implement and evaluate a lifestyle program designed to help women who have high glucose levels during pregnancy make healthful diet and physical activity changes to lose weight. Eligible women will be randomly assigned to life-style intervention or usual medical care.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Women receiving prenatal care at Kaiser Permanente Santa Clara, Santa Teresa, Hayward, and Oakland
  • •Pregnancy complicated by high glucose levels starting November 2011

排除标准

  • •Recognized DM prior to pregnancy
  • •Uncontrolled hypertension during pregnancy
  • •Severe active thyroid disease during pregnancy
  • •Severe diseases of the cardio-pulmonary system
  • •Diagnosis of a severe psychiatric disorder
  • •Diagnosis of cancer
  • •Conditions that lead to diet changes
  • •Addiction to alcohol or illegal drugs
  • •Current corticosteroid medicine use

研究组 & 干预措施

Control

No Intervention

Lifestyle Counseling

Experimental

干预措施: Lifestyle Counseling (Behavioral)

结局指标

主要结局

postpartum body weight

时间窗: through 24 months postpartum

次要结局

  • time spent in physical activity (PA) by intensity(through 24 months postpartum)
  • the proportion of women who reach body weight goals(through 24 months postpartum)
  • percent of calories from fat(through 24 months postpartum)
  • postpartum glycemia(through 24 months postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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