Effects of Lifestyle Intervention on Childhood Outcomes in LGA Infants

Childhood Overweight Clinical Trial

Official title:

Childhood Health Outcomes in Term, Large-for-gestational-age Infants: Effects of Lifestyle Intervention in the Postnatal First Year

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04661449
• Other study ID #: XH-20-023
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2021
• Est. completion date: November 30, 2029

Study information

• Verified date: December 2020
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: November 30, 2029
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

• term

• large-for-gestational-age infants

Exclusion Criteria:

• major genetic disorder

• congenital anomalies

• severe digestive disease

Related Conditions & MeSH terms

• Childhood Overweight
• Overweight
• Pediatric Obesity

Intervention

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).

Locations

Country	Name	City	State
China	Xinhua Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	at 2 years old
Secondary	Carotid intima-media thickness (CIMT) at 2 years old	Carotid intima-media thickness (CIMT) will be measured by experienced Pediatric Cardiologist.	at 2 years old
Secondary	Association of BMI at 2 years old with biomarkers in cord blood	Biomarkers include: serum leptin, insulin, IGF - ?, blood lipid series, adiponectin	at 2 years old
Secondary	Association of BMI at 7 years old with biomarkers in cord blood	Biomarkers include: serum leptin, insulin, IGF - ?, blood lipid series, adiponectin	at 7 years old
Secondary	Blood pressure at 7 years old	Blood pressure will be measured by experienced nurses.	at 7 years old
Secondary	Carotid intima-media thickness (CIMT) at 7 years old	Carotid intima-media thickness (CIMT) will be measured by experienced Pediatric Cardiologist.	at 7 years old