Born In Guangzhou Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,160
- 试验地点
- 2
- 主要终点
- Child growth parameters (3 years)
研究概览
简要总结
The main objective of this study is to test the efficacy of an intervention package (dietary, physical and lifestyle modification) during pregnancy in improving the clinical outcomes of mother-infant dyads.
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
- Double (Care Provider, 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
- •Pregnant women attending prenatal care at Guangzhou Women and Children's Medical Center (GWCMC) <20 weeks' gestation
- •Pregnant women plan to deliver at GWCMC
- •Pregnant women intend to reside in Guangzhou for at least 3 years
排除标准
- •Multiple pregnancies
- •Existing medical conditions (uncontrolled diabetes, hypertension or thyroid disease; other serious cardiovascular diseases, respiratory or systematic disorders)
- •Use of drugs (aspirin, metformin, low molecular weight heparin)
- •Women with reading and/or writing difficulties
- •Women with serious mental disorders
- •Women with eating disorders
研究组 & 干预措施
Proactive management during pregnancy
A combination of dietary, physical activity and lifestyle modification.
干预措施: Lifestyle modification (Behavioral)
Standard Care
No additional intervention beyond standard care procedure.
结局指标
主要结局
Child growth parameters (3 years)
时间窗: At three years of age
Weight measured with digital scales in kg, length measured in standing position in cm, using weight and length to derived body mass index, comparing against age and sex-specific references for Z-score.
Maternal gestational weight change
时间窗: From pregnancy until one month postpartum
Maternal weight prior to pregnancy (or within 8 weeks of pregnancy), at around 20, 26, 32 weeks' gestation, before delivery and one month postpartum will be determined by digital scales, changes in maternal weight during pregnancy will be recorded in kg.
Newborn size
时间窗: Day 1 after birth
Weight (kg) will be measured with digital scales and height/length (cm) will be measured in supine with tape, comparing against reference to derived gestational age and sex-specific growth parameter Z-scores. To identify whether the neonates was small/appropriate/large for gestational age.
Neonatal skinfold thickness (at birth)
时间窗: Day 1 after birth
Measured with skinfold caliper, a summation of skinfold thickness at several body sites including triceps, biceps, subscapular, suprailiac and thigh, will be derived in cm.
Child blood lipid profile (3 years)
时间窗: At three years of age
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.
Child blood glucose profile (3 years)
时间窗: At three years of age
Measured by autoanalyzer, blood glucose level in mmol/L.
Maternal blood glucose profile postpartum (3 years)
时间窗: Three years after delivery
Measured by autoanalyzer, blood glucose level in mmol/L.
Maternal blood insulin profile postpartum (3 years)
时间窗: Three years after delivery
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
Maternal blood lipid profile postpartum (3 years)
时间窗: Three years after delivery
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.
Child blood insulin profile (3 years)
时间窗: At three years of age
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
Incidence of pregnancy complications
时间窗: From 20 weeks' gestation until one month postpartum
Incidence of physician-diagnosed pregnancy complications, including gestational diabetes mellitus, hypertensive disorders
次要结局
- Child growth parameters (1 year)(At one year of age)
- Child growth parameters (6 years)(At six years of age)
- Maternal blood sugar profile postpartum (6 years)(Six years after delivery)
- Child skinfold thickness (6 months)(At six months of age)
- Child skinfold thickness (3 years)(At three years of age)
- Child skinfold thickness (6 years)(At six years of age)
- Child growth parameters (6 months)(At six months of age)
- Child blood sugar profile (6 years)(At six years of age)
- Maternal hand grip strength during pregnancy(Between 32-34 weeks' gestation)
- Maternal hand grip strength after delivery(At one month postpartum)
- Maternal blood lipid profile postpartum (6 years)(Six years after delivery)
- Child skinfold thickness (1 year)(At one year of age)
- Child blood lipid profile (6 years)(At six years of age)
- Child blood insulin profile (6 years)(At six years of age)
- Neurological development of child (1 year)(At one year of age)
- Neurological development of child (3 years)(At three years of age)
- Maternal blood insulin profile postpartum (6 years)(Six years after delivery)
- Maternal body composition postpartum(At one month postpartum)
研究者
Xiu Qiu
Director of the Department of Women's Health
Guangzhou Women and Children's Medical Center