Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06117631

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Infant Overweight Body Weight Diabetes Mellitus Risk Glucose Metabolism Disorders Hyperinsulinism Infant Development Infant Nutrition Disorders Infant Obesity Infant Overnutrition Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CommUnity Care: North Central Health Center

Austin, Texas, 78758, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Centering Parenting

Behavioral

See Arm description.

Bright By Text

Behavioral

See Arm description.

Primary outcomes

  1. Assess impact of group-based parent support coaching on infant feeding practices in first 2 years of child's life.

    Time frame: 2- to 24-months of infant age

    Assessment instruments include: Complementary Feeding History questionnaire, Nutrition Data System for Research, Expanded Food and Nutrition Education questionnaire, Infant Feeding Style Questionnaire.

  2. Assess impact of text-based parent support coaching on infant feeding practices in first 2 years of child's life.

    Time frame: 2- to 24-months of infant age

    Assessment instruments include: Complementary Feeding History questionnaire, Nutrition Data System for Research, Expanded Food and Nutrition Education questionnaire, Infant Feeding Style Questionnaire.

  3. Assess impact of group-based parent support coaching in first 2 years of child's life on responsive feeding and healthy sleep practices.

    Time frame: 2- to 24-months of infant age

    Assessment 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.

  4. Assess impact of text-based parent support coaching in first 2 years of child's life on responsive feeding and healthy sleep practices.

    Time frame: 2- to 24-months of infant age

    Assessment 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.

  5. Determine how parent support coaching and other predictors relate to infant and toddler growth in Latino children in first 2 years of life.

    Time frame: 2- to 24-months of infant age

    Assessment of variability of growth patterns by modeling of trajectories of weight gain in first 2 years of life.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 7, 2023
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.