Effects of Lifestyle Intervention on Childhood Outcomes in LGA Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Childhood Health Outcomes in Term, Large-for-gestational-age Infants: Effects of Lifestyle Intervention in the Postnatal First Year

Conditions
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Childhood Overweight

Intervention / Treatment
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* Other: Comprehensive lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: term large-for-gestational-age infants Exclusion Criteria: major genetic disorder congenital anomalies severe digestive disease

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Intervention<br>every 3 months within 1 year. | Other: Comprehensive lifestyle intervention<br>* 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).<br>|
| No Intervention: control group<br>Regular follow-up every 6 months within 1 year. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at 2 years old | 
| 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 | at 7 years old | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at 2 years old | 
| Carotid intima-media thickness (CIMT) at 2 years old | Carotid intima-media thickness (CIMT) will be measured by experienced Pediatric Cardiologist. | at 2 years old | 
| Association of BMI at 2 years old with biomarkers in cord blood | Biomarkers include: serum leptin, insulin, IGF - Ⅰ, blood lipid series, adiponectin | at 2 years old | 
| Association of BMI at 7 years old with biomarkers in cord blood | Biomarkers include: serum leptin, insulin, IGF - Ⅰ, blood lipid series, adiponectin | at 7 years old | 
| Blood pressure at 7 years old | Blood pressure will be measured by experienced nurses. | at 7 years old | 
| Carotid intima-media thickness (CIMT) at 7 years old | Carotid intima-media thickness (CIMT) will be measured by experienced Pediatric Cardiologist. | at 7 years old | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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large for gestational age