Project Sueño: Sleep & Understanding Early Nutrition in Obesity

Last updated: November 1, 2023
Sponsor: University of Texas at Austin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Metabolic Syndrome

High Cholesterol (Hyperlipidemia)

Obesity

Treatment

Centering Parenting

Bright by Text

Clinical Study ID

NCT06117631
STUDY00003961
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Mother smokes
  • Mother works primarily at night
  • Infant has metabolic or chromosomal disorders, chronic neurological or respiratoryconditions, or developmental disability

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: Centering Parenting
Phase:
Study Start date:
July 01, 2023
Estimated Completion Date:
December 31, 2025

Study Description

This study seeks to intervene just in time for families at highest risk of early life obesity and obesity-related comorbidities (such as Type 2 diabetes), to prevent intergenerational obesity and metabolic syndrome for Hispanic families. For those children exposed to gestational diabetes (GDM) or maternal overweight/obesity in utero, there is a critical need for effective early life strategies for secondary prevention of obesity, to interrupt intergenerational transmission. This study will offer community-embedded coaching to families learn how to responsively feed their babies using 2 models: group visits and text-based. The investigators will also assess responsive sleep practices; i.e. paying attention to an infant's sleep cues as well as hunger cues, breaking the feeding to sleep association, and not overfeeding at night. Infant and toddler sleep, both duration and quality, has not been well studied in this population for early life obesity prevention. This study is specifically exploring pathways from prenatal gestational diabetes and maternal overweight/obesity to dysregulated infant feeding and sleep. Few interventions around infant sleep exist for the Hispanic population, or resources in Spanish-language around sleep coaching; let alone analyses on parents' self-efficacy and behavior change. In this study, the investigators aim to better understand the complex socioenvironmental drivers of infant sleep and feeding behaviors, and the prenatal risks related to infant rapid weight gain, in order to target modifiable factors in this population.

Connect with a study center

  • CommUnity Care: North Central Health Center

    Austin, Texas 78758
    United States

    Active - Recruiting

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