Mobile Instant Messaging-based Lifestyle Interventions for Preventing Gestational Diabetes in High-risk Pregnant Women: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 944
- 试验地点
- 4
- 主要终点
- GDM diagnosis
研究概览
简要总结
The goal of this randomised controlled trial is to test the effectiveness of a mobile instant messaging-based lifestyle intervention in pregnant women at risk of gestational diabetes
详细描述
Gestational diabetes mellitus (GDM) is one of the most common medical conditions during pregnancy, affecting about 1 in 7 live births worldwide. There remains a lack of proven preventive strategies for GDM that could be readily adopted in clinical practice. Recent studies have suggested that lifestyle intervention delivered via mobile phone could help pregnant women prevent GDM, but more evidence is needed. This study aims to test a mobile instant messaging-based lifestyle intervention for GDM prevention in pregnant women at risk 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ethnic Chinese singleton pregnant woman in <14 weeks of gestation
- •Aged 18 years or above
- •Own a mobile phone with an instant messaging app
- •Not participating in similar trials on diabetes or lifestyle modifications
- •Have at least one of the following risk factors for GDM:
- •Age ≥35 years at the expected date of delivery
- •Body mass index (BMI) ≥ 25 kg/m2 pre-pregnancy or in the first trimester
- •Family history of diabetes in first-degree relative
- •Previous GDM or delivered a baby with birthweight ≥4 kg
排除标准
- •Pre-existing diabetes or other medical conditions that may affect metabolism (e.g., thyroid disorders) or psychiatric disorders
结局指标
主要结局
GDM diagnosis
时间窗: About 28th gestational week
GDM diagnosed by a 2-hour 75g oral glucose tolerance test interpreted according to the World Health Organization's 2013 criteria
次要结局
- Hypertensive disorders of pregnancy(During pregnancy)
- Gestational weight gain(From baseline to the end of pregnancy (delivery))
- Birthweight(At birth)
- Neonatal hypoglycaemia(At birth)
- Pharmacological therapy for hyperglycaemia(During pregnancy)
- Mode of birth(At delivery)
- Gestational age at birth(At delivery)
- Small for gestational age(At birth)
- Large for gestational age(At birth)
- Neonatal death(Within 28 days after birth)
- Preterm birth(At birth)
- Stillbirth(During pregnancy)
研究者
Tzu Tsun Luk
Research Assistant Professor
The University of Hong Kong