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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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreTrial 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.
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Who is running the clinical trial?
University of Texas at AustinLead Sponsor
353 Previous Clinical Trials
81,004 Total Patients Enrolled
8 Trials studying Diabetes Mellitus
1,571 Patients Enrolled for Diabetes Mellitus
American Diabetes AssociationOTHER
139 Previous Clinical Trials
99,366 Total Patients Enrolled
73 Trials studying Diabetes Mellitus
19,827 Patients Enrolled for Diabetes Mellitus
Megan J Gray, MD,MPH,FAAPPrincipal InvestigatorUniversity of Texas at Austin - Dell Medical School
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I a viable candidate for participating in this research?
"This clinical trial is accepting up to 240 patients who are between 18 and 45 years old, have been diagnosed with metabolic syndrome."
Answered by AI
How many individuals have registered for this research trial?
"Affirmative, the information available on clinicaltrials.gov suggests that this research is actively seeking participants. Having first been posted on July 1st 2023 and updated recently on November 1st of the same year, 240 people are required to take part in this trial at a single site."
Answered by AI
Is this research protocol permitting participants aged 25 and older?
"The study is seeking participants aged 18-45."
Answered by AI
Are there vacancies remaining for patients to participate in this experiment?
"Based on the information found online, this medical trial is actively engaging in recruitment. The first posting occurred on July 1st 2023 and the last update was made to the listing November 1st of that same year."
Answered by AI
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