Healthy Start: Exploring the Fuel-mediated Programming of Neonatal Growth

Recruiting

• Conditions: Obesity; Pregnancy
• Interventions: Other: Maternal factors

• Registration Number: NCT02273297
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The purpose of this study is to establish and follow longitudinally a cohort of ethnically diverse pregnant women and their offspring, in order to explore the hypothesis that fetal over-nutrition is associated with obesity, metabolic, and cardiovascular abnormalities in the offspring.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2821

Inclusion Criteria

• Pregnant women and infants
• Prior to 23 completed weeks of gestation
• Live in Colorado

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Exclusion Criteria

• Multiple gestation

• Preexisting

  • cancer
  • psychiatric disease
  • steroid-dependent asthma, or
  • diabetes

• Previous premature delivery prior to 25 weeks gestation or fetal demise

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women and their offspring	Maternal factors	Ethnically diverse pregnant women and their offspring

Primary Outcome Measures

Name	Time	Method
Fat mass	5 years	Body composition assessed via air displacement plethysmography to calculate fat mass and fat-free mass.

Secondary Outcome Measures

Name	Time	Method
Fat mass	5 months	Body composition assessed via air displacement plethysmography to calculate fat mass and fat-free mass.

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States