Effects of Lifestyle Intervention on Childhood Outcomes in LGA Infants

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-1
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

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 volunteers

Qualifiers

term

large-for-gestational-age infants

Disqualifiers

major genetic disorder

congenital anomalies

severe digestive disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Comprehensive lifestyle intervention

    Other intervention

    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).

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: Lifestyle InterventionExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
at 2 years old
2

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

Time frame
at 7 years old

Secondary outcomes

1

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.

Time frame
at 2 years old
2

Carotid intima-media thickness (CIMT) at 2 years old

Carotid intima-media thickness (CIMT) will be measured by experienced Pediatric Cardiologist.

Time frame
at 2 years old
3

Association of BMI at 2 years old with biomarkers in cord blood

Biomarkers include: serum leptin, insulin, IGF - Ⅰ, blood lipid series, adiponectin

Time frame
at 2 years old
4

Association of BMI at 7 years old with biomarkers in cord blood

Biomarkers include: serum leptin, insulin, IGF - Ⅰ, blood lipid series, adiponectin

Time frame
at 7 years old

Other outcomes

Sponsors and contacts

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