Effects of Lifestyle Intervention on Childhood Outcomes in LGA Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Comprehensive lifestyle intervention.
- Who it may be relevant to
- Registry conditions: Childhood Overweight. Basic parameters: 1 Day — 1 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Childhood Health Outcomes in Term, Large-for-gestational-age Infants: Effects of Lifestyle Intervention in the Postnatal First Year
Overview
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
- Other Comprehensive lifestyle 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).
Primary outcome measures
- Rate of overweight/obesity at 2 years old [Time frame: at 2 years old]
- Rate of overweight/obesity at 7 years old [Time frame: at 7 years old]
Secondary outcome measures (6)
- Neurodevelopmental assessment at 2 years old [Time frame: at 2 years old]
- Carotid intima-media thickness (CIMT) at 2 years old [Time frame: at 2 years old]
- Association of BMI at 2 years old with biomarkers in cord blood [Time frame: at 2 years old]
- Association of BMI at 7 years old with biomarkers in cord blood [Time frame: at 7 years old]
- Blood pressure at 7 years old [Time frame: at 7 years old]
- Carotid intima-media thickness (CIMT) at 7 years old [Time frame: at 7 years old]
Eligibility criteria
Inclusion criteria
- term
- large-for-gestational-age infants
Exclusion criteria
- major genetic disorder
- congenital anomalies
- severe digestive disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Xinhua Hospital — Shanghai
Identifiers
NCT: NCT04661449 · XH-20-023