Effects of Lifestyle Intervention on Childhood Outcomes in LGA Infants
Childhood Health Outcomes in Term, Large-for-gestational-age Infants: Effects of Lifestyle Intervention in the Postnatal First Year
1 other identifier
interventional
138
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2020
CompletedFirst Posted
Study publicly available on registry
December 10, 2020
CompletedStudy Start
First participant enrolled
January 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2029
ExpectedFebruary 5, 2021
December 1, 2020
2.9 years
November 1, 2020
February 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Neurodevelopmental assessment at 2 years old
at 2 years old
Carotid intima-media thickness (CIMT) at 2 years old
at 2 years old
Association of BMI at 2 years old with biomarkers in cord blood
at 2 years old
Association of BMI at 7 years old with biomarkers in cord blood
at 7 years old
Blood pressure at 7 years old
at 7 years old
- +1 more secondary outcomes
Study Arms (2)
Lifestyle Intervention
EXPERIMENTALevery 3 months within 1 year.
control group
NO INTERVENTIONRegular follow-up every 6 months within 1 year.
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).
Eligibility Criteria
You may qualify if:
- term
- large-for-gestational-age infants
You may not qualify if:
- major genetic disorder
- congenital anomalies
- severe digestive disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xinhua Hospital
Shanghai, Shanghai Municipality, 2000892, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2020
First Posted
December 10, 2020
Study Start
January 22, 2021
Primary Completion
November 30, 2023
Study Completion (Estimated)
November 30, 2029
Last Updated
February 5, 2021
Record last verified: 2020-12