Effects of Lifestyle Intervention on Childhood Outcomes in LGA Infants
- Conditions
- Childhood Overweight
- Interventions
- Other: Comprehensive lifestyle intervention
- Registration Number
- NCT04661449
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 138
- term
- large-for-gestational-age infants
- major genetic disorder
- congenital anomalies
- severe digestive disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lifestyle Intervention Comprehensive lifestyle intervention every 3 months within 1 year.
- Primary Outcome Measures
Name Time Method Rate of overweight/obesity at 7 years old 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 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
- Secondary Outcome Measures
Name Time Method Neurodevelopmental assessment at 2 years old at 2 years old Bayley III's assessment of infants is divided into five areas: cognition, language, body movement, social emotion and adaptive behavior.
Association of BMI at 2 years old with biomarkers in cord blood at 2 years old Biomarkers include: serum leptin, insulin, IGF - Ⅰ, blood lipid series, adiponectin
Association of BMI at 7 years old with biomarkers in cord blood at 7 years old Biomarkers include: serum leptin, insulin, IGF - Ⅰ, blood lipid series, adiponectin
Carotid intima-media thickness (CIMT) at 2 years old at 2 years old Carotid intima-media thickness (CIMT) will be measured by experienced Pediatric Cardiologist.
Blood pressure at 7 years old at 7 years old Blood pressure will be measured by experienced nurses.
Carotid intima-media thickness (CIMT) at 7 years old at 7 years old Carotid intima-media thickness (CIMT) will be measured by experienced Pediatric Cardiologist.
Trial Locations
- Locations (1)
Xinhua Hospital
🇨🇳Shanghai, Shanghai, China