SPARK: Smart Phone App for Gestational Diabetes Patients Supporting Key Lifestyle Behaviors and Glucose Control
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Glucose control
研究概览
简要总结
Gestational diabetes mellitus (GDM) is an increasing public health challenge. Innovative, effective and scalable lifestyle interventions to support women with GDM to manage their disease and to prevent adverse obstetric and neonatal outcomes as well as later morbidity are requested.The aim of this project is to evaluate whether a novel, mobile health (mHealth) platform (SPARK) can improve self-management of GDM and prevent adverse maternal and offspring outcomes. SPARK is a multi-centre randomised controlled trial recruiting women diagnosed with GDM in South Eastern Sweden. Women will be randomised to the control or intervention group. All women will receive standard care. The intervention group will also receive support through the SPARK platform for healthy eating, physical activity and glycaemic control. Pregnancy outcomes are glycaemic control (primary), diet, physical activity, metabolic and inflammatory biomarkers in gestational week 36-37 as well as adverse obstetric and neonatal outcomes. Secondary outcomes also include cardiometabolic risk, physical activity and healthy eating behaviours one-year postpartum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, 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
- 是
入选标准
- •a confirmed diagnosis of GDM detected by oral glucose tolerance test in accordance with the World Health Organization guidelines
排除标准
- •known pre-pregnancy diabetes
- •twin pregnancy
- •<18 years of age
- •severe co-morbidities that would limit participation or a previously diagnosed severe psychiatric illness.
研究组 & 干预措施
Control arm
Standard care i.e., the routine treatment program for GDM delivered by the care provider.
SPARK app
Access to the SPARK app which will provide support for a healthier diet and increased physical activity as well as daily monitoring of blood glucose levels.
干预措施: SPARK (Behavioral)
结局指标
主要结局
Glucose control
时间窗: At the end of the intervention in gestational weeks 36-37
Time in Range percent of time for glucose levels within clinical target levels using continous glucose monitoring
HbA1c
时间窗: At the end of the intervention in gestational weeks 36-37
Glycosylated hemoglobulin
次要结局
- Diet intake quality using three dietary recalls by means of the Riksmaten Flex method(One year post partum)
- Gestational weight gain(From pre-prepregnancy up to 40 weeks of gestation)
- Physical activity using accelerometry(One year post partum)
- Incidence of pre-eclampsia(Up to delivery)
- Incidence of Caesarean sections(Up to delivery)
- Incidence of pregnancy induced hypertension(Up to delivery)
- Metformin/insulin treatment(Up to delivery)
- Preterm birth(Up to delivery)
- Infant birth weight(At birth)
- Infant birth length(At birth)
- Infant Apgar score(At birth)
- Incidence of large-for gestational-age infant(At birth)
- Infant shoulder dystocia(At birth)
- Infant hypoglycaemia(At birth)
- Glucose control(From inclusion (baseline) to end of intervention in gestational week 36-37)
- Glycaemic variability I(At the end of the intervention in gestational week 36-37)
- Glycaemic variability II(At the end of the intervention in gestational week 36-37)
- Delivery complications(At delivery)
- Hospital stay(The first week post partum)
- Glucose- insulin treatment during delivery(During delivery)
- Metabolic and inflammatory biomarkers I(At gestational weeks 36-37)
- Metabolic and inflammatory biomarkers II(At gestational weeks 36-37)
- Metabolic and inflammatory biomarkers III(At gestational week 36-37)
- Metabolic and inflammatory biomarkers IV(At gestational week 36-37)
- Metabolic and inflammatory biomarkers V(At gestational week 36-37)
- Maternal cardiometabolic risk profile(One year post partum)
- Metabolic and inflammatory biomarkers VI(At gestational week 36-37)
- Glycaemic variability III(Full intervention period (up to 3 months))
- Microvascular function I(One year post partum)
- Microvascular function II(One year post partum)
研究者
Marie Löf, docent
Professor
Karolinska Institutet