Lifestyle changes to improve health outcomes in large-for-gestational-age infants
Childhood Health Outcomes in Term, Large-for-gestational-age Infants: Effects of Lifestyle Intervention in the Postnatal First Year
This study is testing if a special program to help parents with feeding and healthcare can improve the health and development of large-for-gestational-age infants and reduce their chances of being overweight as they grow up.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 1 Day to 1 Month |
| Sex | All |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04661449 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a comprehensive lifestyle intervention on large-for-gestational-age (LGA) infants to reduce the risk of childhood overweight and improve neurodevelopmental outcomes. Infants will be randomly assigned to either an intervention group, receiving regular follow-up and guidance on feeding and healthcare, or a control group with standard follow-up. The primary outcomes include rates of overweight/obesity at ages two and seven, along with assessments of neurodevelopment and cardiovascular health. The study also aims to explore the relationship between early biomarkers and later health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are term infants classified as large-for-gestational-age.
Not a fit: Patients with major genetic disorders, congenital anomalies, or severe digestive diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of childhood obesity and improve developmental health in LGA infants.
How similar studies have performed: Other studies have shown promising results with lifestyle interventions in similar populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * term * large-for-gestational-age infants Exclusion Criteria: * major genetic disorder * congenital anomalies * severe digestive disease
Where this trial is running
Shanghai, Shanghai Municipality
- Xinhua Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.