Clinical trial

Project Sueño: Sleep & Understanding Early Nutrition in Obesity

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06117631

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 45 Years
SexFemale
Healthy volunteersAccepted
ConditionInfant Overweight, Infant Obesity, Infant Overnutrition, Infant Development, Metabolic Syndrome, Diabetes Mellitus Risk

Full registry criteria

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

Treatments and study arms

Centering Parenting

Behavioral

See Arm description.

Bright by Text

Behavioral

See Arm description.

Primary outcomes

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 age

Assessment 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 age

Assessment 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 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.

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 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.

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 age

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

CommUnity Care: North Central Health Center🇺🇸 Austin, Texas, United States