NCT04585581进行中（未招募）不适用
Before the Beginning: Preconception Lifestyle Interventions to Improve Future Metabolic Health
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Plasma glucose concentration
研究概览
简要总结
The aim of this study is to investigate whether the combination of high intensity exercise and time restricted eating before and during pregnancy can reduce the risk of hyperglycaemia during pregnancy.
详细描述
Women who are planning a pregnancy will be recruited into a parallel groups randomised controlled trial where the intervention will consist of high intensity training and time-restricted eating. The intervention will continue throughout pregnancy. The investigators will assess whether this lifestyle intervention can effect maternal and offspring cardiometabolic health.
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
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •contemplating pregnancy within the next six months
- •At least one of the following criteria: BMI ≥ 25 < 40 kg/m2, gestational diabetes in a previous pregnancy, previous infant > 4.5 kg, fasting plasma glucose > 5.3 mmol/L, or Non-European ethnicity
排除标准
- •On-going pregnancy
- •Trying to conceive ≥ 6 cycles at study entry
- •Known diabetes (type 1 or 2)
- •Shift work that includes night shifts > 2 days per week
- •Previous hyperemesis
- •Known cardiovascular diseases
- •High intensity exercise ≥ 2 hours/week the last 3 months
- •Habitual eating window ≤ 12 hours
结局指标
主要结局
Plasma glucose concentration
时间窗: Gestational week 28
Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose)
次要结局
- Head circumference of infant(Delivery)
- Fat mass(Baseline, intervention week 8, gestational week 12 and 28)
- Measured physical activity(From baseline and throughout the study period.)
- Plasma glucose concentration(Gestational week 12)
- HbA1c(Baseline, intervention week 8, gestational week 12 and 28)
- Glucose(Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery))
- Diet intake(Every 8 week throughout the trial.)
- Insulin(Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery))
- Cytokines(Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery))
- Total cholesterol(Baseline, intervention week 8, gestational week 12 and 28)
- Triglycerides(Baseline, intervention week 8, gestational week 12 and 28)
- Infant bone mass(Within 72 hours of birth and after 6 weeks post delivery)
- High density lipoprotein cholesterol(Baseline, intervention week 8, gestational week 12 and 28)
- Low density lipoprotein cholesterol(Baseline, intervention week 8, gestational week 12 and 28)
- Low density cholesterol(Baseline, intervention week 8, gestational week 12 and 28)
- Psychological general well being(Baseline, intervention week 8, gestational week 12 and 28, and every 8 week until delivery or until the participant is excluded from the trial due to not conceiving within 6 months from baseline)
- Time to pregnancy(From baseline to pregnancy (up to 36 weeks from enrollment))
- Birth weight (infant)(Delivery)
- Blood pressure (Infant)(Within 72 hours of birth and after 6 weeks post delivery)
- Homocysteine(Baseline, intervention week 8, gestational week 12 and 28)
- Continuous glucose monitoring(Baseline and 8 weeks intervention)
- Chronotype(Baseline, intervention week 8, gestational week 12 and 28, and every 8 week until delivery or until the participant is excluded from the trial due to not conceiving within 6 months from baseline)
- Apgar score(Delivery, after 1, 5 and 10 minutes)
- ICU admission(Delivery)
- Infant muscle mass(Within 72 hours of birth and after 6 weeks post delivery)
- Insulin sensitivity(Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery))
- Muscle mass(Baseline, intervention week 8, gestational week 12 and 28)
- Psychological well-being(Baseline, intervention week 8, gestational week 12 and 28 and every 8 week throughout the trial.)
- Cardiac function (Infant)(Within 72 hours of birth and after 6 weeks post delivery)
- Adipokines (Adiponectin, Leptin, Ghrelin)(Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery))
- Blood pressure(Baseline, intervention week 8, gestational week 12 and 28)
- Birth length (infant)(Delivery)
- Congenital malformation(Delivery)
- Gestational age at birth(Delivery)
- Length of stay at hospital(Delivery)
- Infant total body mass(Within 72 hours of birth and after 6 weeks post delivery)
- Infant fat mass(Within 72 hours of birth and after 6 weeks post delivery)
- Infant hydration status(Within 72 hours of birth and after 6 weeks post delivery)
- Total body mass(Baseline, intervention week 8, gestational week 12 and 28)
- Visceral fat area(Baseline, intervention week 8, gestational week 12 and 28)
- Cardiorespiratory fitness(Baseline and intervention week 8)
- Self-reported physical activity(Baseline, intervention week 8, gestational week 12 and 28, and every 8 week until delivery or until the participant is excluded from the trial due to not conceiving within 6 months from baseline)
- Sleep(Baseline, intervention week 8, gestational week 12 and 28, and every 8 week until delivery or until the participant is excluded from the trial due to not conceiving within 6 months from baseline)
研究者
研究点 (1)
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