Effects of Lifestyle Intervention on Childhood Outcomes in LGA Infants

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04661449
• Collaborator: (none)
• Enrollment: 138
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 106.3
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Overweight	Other: Comprehensive lifestyle intervention	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 138 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized controlled trialrandomized controlled trial
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Childhood Health Outcomes in Term, Large-for-gestational-age Infants: Effects of Lifestyle Intervention in the Postnatal First Year
• Actual Study Start Date: Jan 22, 2021
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Nov 30, 2029

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Rate of overweight/obesity at 2 years old [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

2. Rate of overweight/obesity at 7 years old [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

1. Neurodevelopmental assessment at 2 years old [at 2 years old]

   Bayley III's assessment of infants is divided into five areas: cognition, language, body movement, social emotion and adaptive behavior.

2. Carotid intima-media thickness (CIMT) at 2 years old [at 2 years old]

   Carotid intima-media thickness (CIMT) will be measured by experienced Pediatric Cardiologist.

3. Association of BMI at 2 years old with biomarkers in cord blood [at 2 years old]

   Biomarkers include: serum leptin, insulin, IGF - Ⅰ, blood lipid series, adiponectin

4. Association of BMI at 7 years old with biomarkers in cord blood [at 7 years old]

   Biomarkers include: serum leptin, insulin, IGF - Ⅰ, blood lipid series, adiponectin

5. Blood pressure at 7 years old [at 7 years old]

   Blood pressure will be measured by experienced nurses.

6. Carotid intima-media thickness (CIMT) at 7 years old [at 7 years old]

   Carotid intima-media thickness (CIMT) will be measured by experienced Pediatric Cardiologist.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 1 Month
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• term

• large-for-gestational-age infants

Exclusion Criteria:

• major genetic disorder

• congenital anomalies

• severe digestive disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xinhua Hospital	Shanghai	Shanghai	China	2000892

Sponsors and Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT04661449
• Other Study ID Numbers: XH-20-023
• First Posted: Dec 10, 2020
• Last Update Posted: Feb 5, 2021
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: large for gestational age
• Additional relevant MeSH terms: Pediatric Obesity; Overweight

Study Results

No Results Posted as of Feb 5, 2021