← Back to Search

Sleep & Nutrition Education for Childhood Obesity

N/A

Recruiting

Led By Megan J Gray, MD,MPH,FAAP

Research Sponsored by University of Texas at Austin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2- to 24-months of infant age

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help moms feed and put their babies to sleep better, with the goal of preventing obesity in high-risk populations.

Who is the study for?

This trial is for Hispanic mothers over 18 with healthy, full-term infants under one month old who are patients of CommUnityCare. It's not for those who smoke, work mainly at night, or have babies with metabolic/chromosomal disorders, chronic neurological/respiratory conditions, or developmental disabilities.

What is being tested?

Project Sueño aims to prevent early obesity and metabolic syndrome by studying how support programs like Bright by Text and Centering Parenting can help mothers make better decisions about their baby's feeding and sleeping habits.

What are the potential side effects?

Since this study focuses on understanding behaviors rather than testing medical treatments, there are no direct side effects from interventions like Bright by Text or Centering Parenting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2- to 24-months of infant age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2- to 24-months of infant age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2- to 24-months of infant age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group A: Centering ParentingExperimental Treatment1 Intervention

At each well-child check from 2- to 24-months, a trained bilingual facilitator from the CommUnityCare Centering Parenting program will present curriculum in person during 2-hour visits in a room with 3-8 mother-baby pairs per group. During each session, each mother-baby pair will be pulled out to a private medical room for a brief individual well child appointment with the pediatrician. During this appointment, infant measurements, physical exam, and discussion of unique concerns will take place before the pair returns to the session. There are 8 scheduled well child checks by the age of two, where regular parenting topics will be covered (i.e. discipline, safety, co-parenting, sibling relationships, childcare, development). Each Centering session is expected to last approximately 2 hours, for a total commitment of approximately 16 hours across 8 group sessions over the course of 22 months for each participant. Total time of enrollment should be approximately 22-24 months.

Group II: Group B: Bright by TextActive Control1 Intervention

This group will receive standard of care individual well child checks with their regular CommUnityCare pediatrician, with standard anticipatory guidance on feeding and sleep. Additionally, this group will be enrolled in a text-based parenting coaching program. The Bright by Text program will provide parenting tips two to three times weekly; tailored through community partner United Way of Central Texas offering local parent support and resources. The Bright by Text program is a message subscription program rather than an application. Participants may decide on their own how much to engage with the text-based program, so total time commitment cannot be estimated. Total time of enrollment should be approximately 22-24 months.

Group III: Group C: Standard of CareActive Control1 Intervention

This group will receive standard of care individual well child checks with their regular pediatrician, with standard anticipatory guidance on feeding and sleep. Total time of enrollment should be approximately 22-24 months.

Do I qualify?Apply below to find out