Active — Not RecruitingNot Applicable

Project Sueño: Sleep & Understanding Early Nutrition in Obesity

United States256 participantsStarted 2023-07-01

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 2- to 24-months of infant age

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

Timeframe: 2- to 24-months of infant age

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

Timeframe: 2- to 24-months of infant age

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

Timeframe: 2- to 24-months of infant age

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

Timeframe: 2- to 24-months of infant age

Trial details

NCT IDNCT06117631

SponsorUniversity of Texas at Austin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-31

View on ClinicalTrials.gov More Infant Overweight trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 2- to 24-months of infant age

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

Timeframe: 2- to 24-months of infant age

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

Timeframe: 2- to 24-months of infant age

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

Timeframe: 2- to 24-months of infant age

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

Timeframe: 2- to 24-months of infant age