Prevention of Gestational Diabetes Mellitus With Mobile- and Hospital-based Lifestyle Intervention Among Women of Advanced Maternal Age: a Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 346
- 试验地点
- 1
- 主要终点
- incidence of gestational diabetes mellitus
研究概览
简要总结
This is a single-blind randomized controlled trial, aiming to evaluate the preventive effects of mobile-based combining with hospital-based lifestyle interventions on GDM among women with advanced maternal age. It will be conducted in Beijing, with a sample size of 346. All eligible pregnant women will be randomly assigned to either the intervention or control group, and followed up to delivery.
详细描述
After the adjustment of fertility policy in China, the prevalence of advanced maternal age (AMA) has become a crucial issue in maternal health care. AMA can greatly increase the risk of gestational diabetes mellitus (GDM) during pregnancy. However, there is still a lack of high-quality evidence on GDM preventive interventions for AMA pregnancy in China.
In this randomized study, the investigators aim to examine whether mobile-based combining with hospital-based lifestyle interventions have preventive effects on GDM in AMA pregnancies. The investigators will enroll a total of 346 singleton pregnant women in Peking University First Hospital and randomly assign them to either the intervention or control group. Information of maternal characteristics will be obtained at recruitment. At each prenatal visit, weight and blood pressure of all participants will be measured. For each participant, fasting venous blood samples will be collected at <14 weeks of gestation, 24-28 weeks of gestation and pre-labor, and respectively assayed for fasting plasma glucose, glycated hemoglobin. The primary outcome is the incidence of GDM. The secondary outcomes include maternal glycated hemoglobin level, maternal fasting plasma glucose level, maternal complications, pregnancy outcomes, etc.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •local resident in Beijing
- •Singleton pregnancy
- •Aged ≥35 years
- •Overweight or obesity (Body mass index is between 24 and 27.9 kg/m2 or ≥28 kg/m2)
- •≤12 weeks of gestation
- •written informed consent is obtained
排除标准
- •Diagnosed with type 1 or type 2 diabetes before pregnancy
- •Diagnosed with GDM or impaired glucose tolerance at enrollment
- •use of medication that influences glucose metabolism currently, such as metformin, etc.
- •multiple pregnancy
- •current substance abuse
- •unable to exercise due to physical disability
- •diagnosed severe psychiatric disorder
- •Other conditions not suitable for intervention as judged by physicians
研究组 & 干预措施
Lifestyle intervention group
Participants will be given mobile- and hospital-based lifestyle interventions. The mobile-based interventions including dietary guidance, exercise supervision and weight monitoring will be conducted by trained physicians through WeChat group on cell phone every 1 to 2 weeks. Participants need to report their physical activity and weight information every week through WeChat group. Hospital-based intervention is a ≥5 minutes one-to-one and face-to-face personalized lifestyle counselling leading by a trained physician every 4 weeks during <14 weeks of gestation, every 2 weeks during 14-28 weeks of gestation, and once a week during ≥28 weeks of gestation. Participants' dietary information will be collected for any 3 consecutive days chosen by participants during 12-14 weeks of gestation, 24-28 weeks of gestation and >36 weeks of gestation respectively using a food frequency questionnaire.
干预措施: mobile-based combining with hospital-based lifestyle interventions (Behavioral)
control group
Participants in control group will be managed in accordance with the standard practice.
结局指标
主要结局
incidence of gestational diabetes mellitus
时间窗: from 24 weeks of gestation to delivery.
diagnosed by the oral glucose tolerance test
次要结局
- low birthweight(at delivery)
- birthweight(at delivery)
- Macrosomia(at delivery)
- Gestational age at birth(at delivery)
- Premature delivery(at delivery)
- Apgar score(1 min and 5 min)
- maternal glycated hemoglobin level(at <14 weeks of gestation, 24-28 weeks of gestation, and pre-labor)
- maternal fasting plasma glucose level(at <14 weeks of gestation, 24-28 weeks of gestation, and pre-labor)
- maternal gestational weight gain(from recruitment to delivery)
- incidence of gestational hypertension(from 20 weeks of gestation to delivery.)
- incidence of pre-eclampsia(from 20 weeks of gestation to delivery.)
- delivery mode(at delivery)
- maternal dietary information(any 3 consecutive days chosen randomly by participants during 12-14 weeks of gestation, 24~28 weeks of gestation and >36 weeks of gestation respectively)
- maternal physical activity information(every 1-2 weeks during enrollment to delivery)