Project Sueño: Sleep & Understanding Early Nutrition in Obesity

November 1, 2023 updated by: Megan Gray, University of Texas at Austin

First Thousand Days: Prevention of Early Life Obesity in Latino Infants and Toddlers

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • CommUnity Care: North Central Health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Centering Parenting
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.
Behavioral: Centering Parenting
See Arm description.
Active Comparator: Group B: Bright by Text
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.
Behavioral: Bright by Text
See Arm description.
No Intervention: Group C: Standard of Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess impact of group-based parent support coaching on infant feeding practices in first 2 years of child's life.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
2- to 24-months of infant age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

American Diabetes Association

Investigators

  • Principal Investigator: Megan J Gray, MD,MPH,FAAP, University of Texas at Austin - Dell Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003961

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared with individuals who are collaborating with the research team on this study; these investigators will be added to the IRB and/or only provided with a limited deidentified dataset.

Limited, de-identified aggregate data will also be shared with the following data repositories:

  • National Sleep Research Resource (NSRR): will share physiological signals and de-identified clinical data
  • National Children's Study (NCS) Archive: will share intervention protocol and program feedback to serve as a guide for future interventions
  • Harvard Dataverse: will share qualitative data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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