Childhood Overweight
Conditions
Keywords
large for gestational age
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.
Interventions
Feeding 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).
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
No
Inclusion criteria
* term * large-for-gestational-age infants
Exclusion criteria
* major genetic disorder * congenital anomalies * severe digestive disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| Blood pressure at 7 years old | at 7 years old | Blood pressure will be measured by experienced nurses. |
| 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. |
Countries
China
Outcome results
None listed