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Project Sueño: Sleep & Understanding Early Nutrition in Obesity
The purpose of the study is to understand how mothers think and feel about feeding their babies and putting them to sleep, understand more about programs that can support mothers taking care of babies, and how professionals can be most helpful in helping mothers make decisions about their baby's feeding and sleeping. The overarching goal is to prevent early life obesity and progression to metabolic syndrome in high-risk populations, starting with healthy toddler weights by age 2 years.
Conditions:
🦠 Infant Overweight 🦠 Infant Obesity 🦠 Infant Overnutrition 🦠 Infant Development 🦠 Metabolic Syndrome 🦠 Diabetes Mellitus Risk
🗓️ Study Start (Actual) 1 July 2023
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 240
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Austin, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Mother to infant born full term \> 37 weeks, and are under 1 month of age
    • * Infant is singleton
    • * Infant has no identified health problems
    • * Infant is patient of CommUnityCare
    • * Mother is 18 years of age
    • * Mother is Latino/Hispanic ethnicity
    • * Mother is willing to commit to study follow-up visits

    Exclusion Criteria:

    • * Mother smokes
    • * Mother works primarily at night
    • * Infant has metabolic or chromosomal disorders, chronic neurological or respiratory conditions, or developmental disability
Ages Eligible for Study: 18 Years to 45 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 May 2023
  • First Submitted that Met QC Criteria 1 November 2023
  • First Posted 7 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 November 2023
  • Last Update Posted 7 November 2023
  • Last Verified November 2023
I'm interested ...!!