Dietary Management of Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Changes in blood glucose levels over time
研究概览
简要总结
The goal of this clinical trial is to test effect of dietary management program based on the nudge strategy in gestational diabetes mellitus patients. The main questions it aims to answer is whether the dietary management program is effective for the diet management behavior of gestational diabetes mellitus patients.
Participants will receive a 12 week dietary management program. The intervention group will receive a diet management program based on the nudge strategy, and the control group will receive a routine dietary management program. Researchers will compare two group's glycemic control and pregnancy outcomes and to see if effective for the diet management behavior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meeting the diagnostic criteria related to GDM by oral glucose tolerance test (OGTT), etc.
- •Singleton pregnancy
- •Age ≥ 18 years
- •Gestational weeks 24-28
- •Informed consent for voluntary participation in this study
排除标准
- •1.Patients with significant heart, liver, lung and other organ failure and malignancy 2.Previous history of psychiatric disorders or existing psychiatric disorders 3.Diabetes combined with other complications such as gestational hypertension Dropout criteria
- •Lost to the study due to unforeseen circumstances
- •Voluntarily requested to withdraw from the study
- •Did not take the intervention as required by the relevant requirements
- •Condition was unstable and could not continue to cooperate.
结局指标
主要结局
Changes in blood glucose levels over time
时间窗: Pre-intervention, 1-month post-intervention and 3-months post-intervention
With the change of intervention and time, it is better for the fasting blood glucose to decrease; With the change of intervention and time, it is better that the 1hPG decreases; With the change of intervention and time, it is better that the 2hPG decreases.
次要结局
- pregnancy outcomes(During the delivery of pregnant women, the relevant data of pregnancy outcome were collected by consulting medical records or telephone follow-up.)
研究者
Wenyao Geng
Principal Investigator
Qingdao University