Integrated Assessment of Sleep, Mental Health, Lifestyle Behaviors, Metabolic Markers, and Perinatal Outcomes in Women With Gestational Diabetes Mellitus: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Composite Adverse Perinatal Outcome
研究概览
简要总结
The goal of this observational study is to learn how sleep quality, mental health, lifestyle behaviors, and metabolic markers are related to glucose control and pregnancy outcomes in women with gestational diabetes mellitus (GDM). The main questions it aims to answer are:
- Do differences in sleep quality, anxiety levels, and eating behaviors relate to differences in glycemic control in women with GDM?
- Are maternal metabolic markers (such as glucose, liver enzymes, and lipid levels) associated with perinatal outcomes such as birth weight, cesarean delivery, and neonatal complications?
- To compare women who undergo short inpatient glucose monitoring with women who undergo home-based digital glucose monitoring to see if the mode of monitoring is related to differences in sleep, mental health, metabolic profiles, or perinatal outcomes.
Participants will:
- Complete questionnaires on sleep, anxiety, lifestyle, and eating behaviors
- Undergo routine laboratory testing, including metabolic and blood markers.
- Have glucose monitored either during a short hospital stay or through home use of the FreeStyle Libre sensor.
- Be followed from GDM diagnosis (24-34 weeks) until delivery to assess maternal and newborn outcomes
详细描述
Gestational diabetes mellitus (GDM) is associated with disturbances in glucose regulation as well as a range of behavioral, psychological, and metabolic factors that may contribute to pregnancy outcomes. This prospective observational cohort study follows pregnant women with newly diagnosed GDM to evaluate how sleep quality, anxiety, eating behaviors, physical activity, and metabolic markers relate to glycemic control and perinatal outcomes.
Participants are managed according to standard clinical pathways at a tertiary obstetric center and are allocated either to short inpatient glucose monitoring or to home-based digital monitoring using the FreeStyle Libre system. These pathways reflect real-world clinical indications and are not assigned by the research team. The study leverages this natural variation to compare differences in behavioral, metabolic, and perinatal profiles between groups.
At enrollment, participants complete validated questionnaires assessing sleep quality (PSQI), anxiety (STAI), and eating behaviors (TFEQ). Clinical assessments and laboratory testing include glucose measures, liver enzymes, blood counts, and other metabolic parameters routinely collected in GDM care. Glucose monitoring data are obtained either from inpatient capillary measurements or from downloaded home-based sensor data, depending on the participant's care pathway.
Participants are followed from diagnosis (24-34 weeks of gestation) until delivery. Perinatal outcomes-including birth weight, mode of delivery, neonatal hypoglycemia, and NICU admission-are collected from medical records after delivery. The study analyzes associations between behavioral factors, metabolic markers, and both glycemic and perinatal outcomes. It also evaluates whether differences in the mode of glucose monitoring correspond to differences in maternal psychological well-being or pregnancy outcomes.
This study aims to generate multidimensional insights that may inform more personalized and less burdensome care models for women with GDM, integrating behavioral, metabolic, and clinical information to improve maternal and neonatal health.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Pregnant women aged 18 years or older
- •New diagnosis of gestational diabetes mellitus (GDM) according to IADPSG criteria
- •Gestational age 24-34 weeks at enrollment
- •Able to complete study questionnaires (sleep, anxiety, eating behavior, lifestyle)
- •Able to provide informed consent
- •For participants in the home-monitoring pathway: ability to use a smartphone and the FreeStyle Libre device
排除标准
- •Pre-existing type 1 or type 2 diabetes mellitus
- •Current preeclampsia or major obstetric complications at enrollment
- •Major psychiatric disorders interfering with participation
- •Chronic use of sedatives or anxiolytic medications
- •Inability to complete questionnaires
- •Planned delivery outside the study's hospital network
- •Any condition judged by clinicians to interfere with participation or data reliability
结局指标
主要结局
Composite Adverse Perinatal Outcome
时间窗: At delivery/birth
Proportion of participants experiencing any of the following outcomes in the newborn: macrosomia (birth weight ≥4000 g), neonatal hypoglycemia requiring intervention, admission to neonatal intensive care unit (NICU), 5-minute Apgar score \<7, or stillbirth.
次要结局
- Sleep Quality (PSQI Score)(At enrollment (24-34 weeks of gestation))
- Anxiety Levels (STAI Score)(At enrollment (24-34 weeks of gestation))
- Eating Behaviors (TFEQ Subscales)(At enrollment (24-34 weeks of gestation))
- Mean Glucose Level(During the 24-36 hour monitoring period (home or inpatient))
研究者
Ivana Pavlinac Dodig
Assoc Prof
University of Split, School of Medicine