The Efficacy of Lifestyle Intervention in Preventing the the Recurrence of Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- GDM
研究概览
简要总结
Gestational diabetes mellitus(GDM) is a commom complication during pregnancy and associated with various adverse pregnancy outcomes for both the mother and her offspring. Imoportantly, with the gradual opening of a two-child policy, more and more Chinese women of reproductive age enter pregnancy have a history of GDM. Our previous study showed that regular exercise commenced in early pregnancy is effective in reducing the risk of developing GDM in Chinese overweight and obese pregant women. Thus, in this study, we want to evaluate the effect of lifestyle intervention with detailed information on how to eat and how to diet in preventing the recurrence of GDM.
详细描述
Gestational diabetes mellitus(GDM) is a commom complication during pregnancy. and the incidence has reached as high as 19.2% in China. GDM is associated with various adverse pregnancy outcomes for both the mother and her offspring, and not only during the perinatal phase, but also in the long term.Thus finding effective way to reduce the risk of GDM is of great importance,especial for women with high GDM risk factors. GDM history is one of the risk factors. Imoportantly, with the gradual opening of a two-child policy, more and more Chinese women of reproductive age enter pregnancy have a history of GDM. Our previous study showed that regular exercise commenced in early pregnancy is effective in reducing the risk of developing GDM in Chinese overweight and obese pregant women. Thus, in this study, we want to evaluate the effect of lifestyle intervention with detailed information on how to eat and how to diet in preventing the recurrence of GDM
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton;
- •non-smoking ;
- •before 12+6 weeks gestation.
排除标准
- •less than 18 years old;
- •unwilling to provide informed consent;
- •cervical insufficiency;
- •women on any medication for pre-existing hypertension, diabetes, cardiac disease, renal disease, systemic lupus erythematosus, thyroid disease or psychosis;
- •women who were currently being treated with metformin or corticosteroids.
研究组 & 干预措施
lifestyle intervention group
Pregnant women allocated to this group receive lifestyle intervention. With the dietary intervention we aimed to promote a healthy pattern of eating but not necessarily to restrict energy intake. With respect to advice on physical activity, we focused on incremental increases in walking from a pedometer assessed or encourage them to do moderate cycling.
干预措施: lifestyle intervention with dietary and exercise recommendation (Behavioral)
control group
Pregnant women allocated to this group receive standard prenatal care.
结局指标
主要结局
GDM
时间窗: 24-28 gestational weeks
According to the new criteria amended in August 2014 in China, GDM was diagnosed when any one value reaches or exceeds 5.1 mmol/L at 0 hours, 10.0 mmol/L at 1 hour, or 8.5 mmol/L at 2 hours. Values of 7.0 mmol/L at 0 hours or 11.1 mmol/L at 2 hours were diagnosed as DM, regardless of the pregnancy stage
次要结局
- birth weight(up to 43 gestational weeks)
- delivery mode(up to 43 gestational weeks)
- macrosomia(up to 43 gestational weeks)
- LGA(up to 43 gestational weeks)
- SGA(up to 43 gestational weeks)
- gestational weeks(up to 43 gestational weeks)
- gestational hypertention(up to 43 gestational weeks)
- pre-eclampsia(up to 43 gestational weeks)
研究者
Wang Chen
Principle investigator
Peking University First Hospital