NCT02763150已完成不适用
Gestational Diabetes Prevention Program
California Polytechnic State University-San Luis Obispo4 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2017年12月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 4
- 主要终点
- Incidence of Gestational Diabetes Mellitus
研究概览
简要总结
The overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women with overweight or obesity.
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
- 是
入选标准
- •Prior diagnosis of gestational diabetes.
- •BMI > 25 kg/m2
- •Planning to have a baby in the next 1-3 years
- •English or Spanish speaking
排除标准
- •Age less than 18 years
- •Women with Type 2 or Type 1 diabetes
- •Current pregnancy
- •Relocating in the next 2 years
- •Medications that affect weight/diabetes
- •Serious current physical disease
- •History of eating disorders
- •History of bariatric surgery
- •Current problems with drug abuse
- •Current treatment of a serious psychological disorder
结局指标
主要结局
Incidence of Gestational Diabetes Mellitus
时间窗: 26 weeks gestation
次要结局
- Changes in maternal levels of fasting glucose(study entry, 16 weeks, 26 weeks gestation)
- Changes in maternal levels of fasting insulin(study entry, 16 weeks, 26 weeks gestation)
- Incidence of cesarean delivery(Delivery)
- Daily caloric intake(study entry, 16 weeks, 26 weeks gestation)
- Changes in maternal levels of systolic and diastolic blood pressure(study entry, 16 weeks, 26 weeks gestation)
- Changes in maternal levels of C-reactive protein(study entry, 16 weeks, 26 weeks gestation)
- Incidence of preeclampsia(Delivery)
- Minutes per week of moderate physical activity(study entry, 16 weeks, 26 weeks gestation)
- Weight changes(study entry, 16 weeks, 26 weeks gestation)
研究者
Suzanne Phelan
Professor
California Polytechnic State University-San Luis Obispo
研究点 (4)
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