NCT04661449|Recruiting
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
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Childhood Health Outcomes in Term, Large-for-gestational-age Infants: Effects of Lifestyle Intervention in the Postnatal First Year
Sponsor study identifier
interventional
138
1 country
1
Study Start
January 22, 2021
Actual (reported)Primary Completion
November 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2020
Actual (reported)December 10, 2020
Actual (reported)January 22, 2021
Actual (reported)November 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
every 3 months within 1 year.
Regular follow-up every 6 months within 1 year.
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Xinhua Hospital
Shanghai, Shanghai Municipality, 2000892, China
First Submitted
November 1, 2020
First Posted
December 10, 2020
Study Start
January 22, 2021
Actual (reported)Primary Completion
November 30, 2023
Sleep and Stigma: Novel Moderators in the Relationship Between Weight Status and Cognitive Function
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 5, 2021
Record last verified: 2020-12
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Source: ClinicalTrials.gov.
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