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Project Sueño: Sleep & Understanding Early Nutrition in Obesity

First Thousand Days: Prevention of Early Life Obesity in Latino Infants and Toddlers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06117631
Enrollment
256
Registered
2023-11-07
Start date
2023-07-01
Completion date
2027-12-31
Last updated
2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Risk, Infant Development, Infant Obesity, Infant Overnutrition, Infant Overweight, Metabolic Syndrome

Keywords

infant feeding, infant sleep, parenting practices, rapid weight gain, intergenerational obesity, diabetes prevention

Brief 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.

Detailed 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.

Interventions

BEHAVIORALCentering Parenting

See Arm description.

BEHAVIORALBright by Text

See Arm description.

Sponsors

University of Texas at Austin
Lead SponsorOTHER
American Diabetes Association
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Assess impact of group-based parent support coaching on infant feeding practices in first 2 years of child's life.2- to 24-months of infant ageAssessment instruments include: Complementary Feeding History questionnaire, Nutrition Data System for Research, Expanded Food and Nutrition Education questionnaire, Infant Feeding Style Questionnaire.
Assess impact of text-based parent support coaching on infant feeding practices in first 2 years of child's life.2- to 24-months of infant ageAssessment instruments include: Complementary Feeding History questionnaire, Nutrition Data System for Research, Expanded Food and Nutrition Education questionnaire, Infant Feeding Style Questionnaire.
Assess impact of group-based parent support coaching in first 2 years of child's life on responsive feeding and healthy sleep practices.2- to 24-months of infant ageAssessment of parental responsive feeding practices, and infant sleep and temperament. Assessment instruments include: Complementary Feeding History questionnaire, Nutrition Data System for Research, Expanded Food and Nutrition Education questionnaire, Infant Feeding Style Questionnaire, Brief Infant Sleep Questionnaire, Children's Sleep Habits Questionnaire, Infant Toddler Temperament Tool. Sleep will additionally be assessed using 1-week sleep diaries and accelerometry at 2-, 6-, 12-, 18-, and 24-months of age.
Assess impact of text-based parent support coaching in first 2 years of child's life on responsive feeding and healthy sleep practices.2- to 24-months of infant ageAssessment of parental responsive feeding practices, and infant sleep and temperament. Assessment instruments include: Complementary Feeding History questionnaire, Nutrition Data System for Research, Expanded Food and Nutrition Education questionnaire, Infant Feeding Style Questionnaire, Brief Infant Sleep Questionnaire, Children's Sleep Habits Questionnaire, Infant Toddler Temperament Tool. Sleep will additionally be assessed using 1-week sleep diaries and accelerometry at 2-, 6-, 12-, 18-, and 24-months of age.
Determine how parent support coaching and other predictors relate to infant and toddler growth in Latino children in first 2 years of life.2- to 24-months of infant ageAssessment of variability of growth patterns by modeling of trajectories of weight gain in first 2 years of life.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMegan J Gray, MD,MPH,FAAP

University of Texas at Austin - Dell Medical School

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026