Childhood Health Outcomes in Term, Large-for-gestational-age Infants: Effects of Lifestyle Intervention in the Postnatal First Year
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Rate of overweight/obesity at 7 years old
研究概览
简要总结
Large-for-gestational-age (LGA) infants have a higher risk of metabolic disease later in life, and their postnatal growth in early childhood may be associated with long-term adverse outcomes. The purpose of this study is to explore whether comprehensive lifestyle intervention in the first year after birth in LGA infants will reduce the rate of overweight/obesity at childhood and improve neurodevelopmental outcomes and its possible mechanism.
详细描述
Term LGA infants will be randomly divided into two groups shortly after birth: intervention group and control group. Infants in intervention group will attend the follow-up clinic and motor development assessment and guidance will be provided every three months in the first year. Other lifestyle interventions include feeding guidance and healthcare education. Infants in control group will routinely attend the follow-up clinic every six months. Primary outcome is the rate of overweight/obesity at two years old and seven years old. Neurodevelopmental assessment, carotid intima-media thickness (CIMT) and blood pressure at childhood will also be evaluated. The association of the outcome of LGA infants at two years old and the biomarkers in cord blood will be investigated, which includes serum leptin, insulin, insulin-like growth factors -1 (IGF-1), blood lipid series and adiponectin.
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
- 1 Day 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •large-for-gestational-age infants
排除标准
- •major genetic disorder
- •congenital anomalies
- •severe digestive disease
研究组 & 干预措施
Lifestyle Intervention
every 3 months within 1 year.
干预措施: Comprehensive lifestyle intervention (Other)
control group
Regular follow-up every 6 months within 1 year.
结局指标
主要结局
Rate of overweight/obesity at 7 years old
时间窗: at 7 years old
Weight and height will be combined to report BMI in kg/m\^2. According to the intergrowth-21st age-specific BMI standard issued in 2014, BMI ≥ 85th percentile is defined as overweight; BMI ≥ 95th percentile is defined as obesity
Rate of overweight/obesity at 2 years old
时间窗: at 2 years old
Weight and height will be combined to report BMI in kg/m\^2. According to the intergrowth-21st age-specific BMI standard issued in 2014, BMI ≥ 85th percentile is defined as overweight; BMI ≥ 95th percentile is defined as obesity
次要结局
- Neurodevelopmental assessment at 2 years old(at 2 years old)
- Association of BMI at 2 years old with biomarkers in cord blood(at 2 years old)
- Association of BMI at 7 years old with biomarkers in cord blood(at 7 years old)
- Carotid intima-media thickness (CIMT) at 2 years old(at 2 years old)
- Blood pressure at 7 years old(at 7 years old)
- Carotid intima-media thickness (CIMT) at 7 years old(at 7 years old)