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NCT Number: NCT04661449

Effects of Lifestyle Intervention on Childhood Outcomes in LGA Infants

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.

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Key information

Conditions

Childhood Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

1 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinhua Hospital

Shanghai, Shanghai Municipality, 2000892, China

Location status: Recruiting

Location contact

Hongping Xia, Dr

CONTACT

[email protected]

86-21-25078999 ext. 8392

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • term
  • large-for-gestational-age infants

Exclusion criteria

  • major genetic disorder
  • congenital anomalies
  • severe digestive disease

Treatment and study plan

Comprehensive lifestyle intervention

Other

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 outcomes

  1. Rate of overweight/obesity at 2 years old

    Time frame: 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

    Time frame: 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 outcomes

  1. Neurodevelopmental assessment at 2 years old

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: at 7 years old

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

  5. Blood pressure at 7 years old

    Time frame: at 7 years old

    Blood pressure will be measured by experienced nurses.

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

    Time frame: at 7 years old

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

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2029
First posted
Dec 10, 2020
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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