Effects of Lifestyle Intervention on Childhood Outcomes in LGA Infants
Primary Purpose
Childhood Overweight
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Comprehensive lifestyle intervention
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Overweight focused on measuring large for gestational age
Eligibility Criteria
Inclusion Criteria:
- term
- large-for-gestational-age infants
Exclusion Criteria:
- major genetic disorder
- congenital anomalies
- severe digestive disease
Sites / Locations
- Xinhua HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lifestyle Intervention
control group
Arm Description
every 3 months within 1 year.
Regular follow-up every 6 months within 1 year.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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.
Carotid intima-media thickness (CIMT) at 2 years old
Carotid intima-media thickness (CIMT) will be measured by experienced Pediatric Cardiologist.
Association of BMI at 2 years old with biomarkers in cord blood
Biomarkers include: serum leptin, insulin, IGF - Ⅰ, blood lipid series, adiponectin
Association of BMI at 7 years old with biomarkers in cord blood
Biomarkers include: serum leptin, insulin, IGF - Ⅰ, blood lipid series, adiponectin
Blood pressure at 7 years old
Blood pressure will be measured by experienced nurses.
Carotid intima-media thickness (CIMT) at 7 years old
Carotid intima-media thickness (CIMT) will be measured by experienced Pediatric Cardiologist.
Full Information
NCT ID
NCT04661449
First Posted
November 1, 2020
Last Updated
February 2, 2021
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04661449
Brief Title
Effects of Lifestyle Intervention on Childhood Outcomes in LGA Infants
Official Title
Childhood Health Outcomes in Term, Large-for-gestational-age Infants: Effects of Lifestyle Intervention in the Postnatal First Year
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Overweight
Keywords
large for gestational age
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
138 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Intervention
Arm Type
Experimental
Arm Description
every 3 months within 1 year.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Regular follow-up every 6 months within 1 year.
Intervention Type
Other
Intervention Name(s)
Comprehensive lifestyle intervention
Intervention Description
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 Measure Information:
Title
Rate of overweight/obesity at 2 years old
Description
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
Title
Rate of overweight/obesity at 7 years old
Description
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 Outcome Measure Information:
Title
Neurodevelopmental assessment at 2 years old
Description
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
Title
Carotid intima-media thickness (CIMT) at 2 years old
Description
Carotid intima-media thickness (CIMT) will be measured by experienced Pediatric Cardiologist.
Time Frame
at 2 years old
Title
Association of BMI at 2 years old with biomarkers in cord blood
Description
Biomarkers include: serum leptin, insulin, IGF - Ⅰ, blood lipid series, adiponectin
Time Frame
at 2 years old
Title
Association of BMI at 7 years old with biomarkers in cord blood
Description
Biomarkers include: serum leptin, insulin, IGF - Ⅰ, blood lipid series, adiponectin
Time Frame
at 7 years old
Title
Blood pressure at 7 years old
Description
Blood pressure will be measured by experienced nurses.
Time Frame
at 7 years old
Title
Carotid intima-media thickness (CIMT) at 7 years old
Description
Carotid intima-media thickness (CIMT) will be measured by experienced Pediatric Cardiologist.
Time Frame
at 7 years old
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
term
large-for-gestational-age infants
Exclusion Criteria:
major genetic disorder
congenital anomalies
severe digestive disease
Facility Information:
Facility Name
Xinhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
2000892
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongping Xia, Dr
Phone
86-21-25078999
Ext
8392
Email
xiahongping@xinhuamed.com.cn
12. IPD Sharing Statement
Learn more about this trial
Effects of Lifestyle Intervention on Childhood Outcomes in LGA Infants
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