Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06117631
Study type Interventional
Source University of Texas at Austin
Contact Megan J Gray, MD,MPH,FAAP
Phone 512-495-3002
Email megan.gray@austin.utexas.edu
Status Recruiting
Phase N/A
Start date July 1, 2023
Completion date December 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04635202 - Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome N/A
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Completed NCT05343858 - Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Recruiting NCT05040958 - Carotid Atherosclerotic Plaque Load and Neck Circumference
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Completed NCT03289897 - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan N/A
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Active, not recruiting NCT03613740 - Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion Phase 2
Completed NCT04498455 - Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency Phase 4
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT03697382 - Effect of Daily Steps on Fat Metabolism N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT04509206 - Virtual Teaching Kitchen N/A
Completed NCT05124847 - TREating Pediatric Obesity N/A