About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
term
large-for-gestational-age infants
Disqualifiers
major genetic disorder
congenital anomalies
severe digestive disease
Trial design
Parallel
Treatments tested in this trial
Comprehensive lifestyle intervention
Other interventionFeeding guidance: promoting exclusive breastfeeding and healthy diet (Pediatrician). Motor development assessment and guidance: Alberta Infant movement scale (AIMS) evaluation, guidance for motor development (Rehabilitation Therapist). Healthcare education: improvement of environmental exposure (Pediatrician).
Treatment groups
Trial outcomes
Primary outcomes
Rate of overweight/obesity 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
Rate of overweight/obesity 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
Secondary outcomes
Neurodevelopmental assessment at 2 years old
Bayley III's assessment of infants is divided into five areas: cognition, language, body movement, social emotion and adaptive behavior.
Carotid intima-media thickness (CIMT) at 2 years old
Carotid intima-media thickness (CIMT) will be measured by experienced Pediatric Cardiologist.
Association of BMI at 2 years old with biomarkers in cord blood
Biomarkers include: serum leptin, insulin, IGF - Ⅰ, blood lipid series, adiponectin
Association of BMI at 7 years old with biomarkers in cord blood
Biomarkers include: serum leptin, insulin, IGF - Ⅰ, blood lipid series, adiponectin
Sponsors and contacts
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