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

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.

Study Overview

• Status: Recruiting
• Conditions: Childhood Overweight
• Intervention / Treatment: Other: Comprehensive lifestyle intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 2000892
      • Recruiting
      • Xinhua Hospital
      • Contact: Hongping Xia, Dr; Phone Number: 8392 86-21-25078999; Email: xiahongping@xinhuamed.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• term
• large-for-gestational-age infants

Exclusion Criteria:

• major genetic disorder
• congenital anomalies
• severe digestive disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle Intervention; every 3 months within 1 year.	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).
No Intervention: control group; Regular follow-up every 6 months within 1 year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Association of BMI at 2 years old with biomarkers in cord blood	Biomarkers include: serum leptin, insulin, IGF - Ⅰ, blood lipid series, adiponectin	at 2 years old
Association of BMI at 7 years old with biomarkers in cord blood	Biomarkers include: serum leptin, insulin, IGF - Ⅰ, blood lipid series, adiponectin	at 7 years old
Blood pressure at 7 years old	Blood pressure will be measured by experienced nurses.	at 7 years old
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

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2021
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): November 30, 2029

Study Registration Dates

• First Submitted: November 1, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: large for gestational age
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Pediatric Obesity; Overweight
• Other Study ID Numbers: XH-20-023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No