Project Sueño: Sleep & Understanding Early Nutrition in Obesity

NCT06117631 | Active Not Recruiting

• 1 other identifier: STUDY00003961
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant Overweight; Infant Obesity; Infant Overnutrition; Infant Development; Metabolic Syndrome; Diabetes Mellitus Risk

Keywords

infant feeding; infant sleep; parenting practices; rapid weight gain; intergenerational obesity; diabetes prevention

Outcome Measures

Primary Outcomes (5)

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

  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.

  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.

  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.

  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.

  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

Study Arms (3)

Group A: Centering Parenting

EXPERIMENTAL

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

Group B: Bright by Text

ACTIVE COMPARATOR

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

Group C: Standard of Care

NO 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.

Interventions

Centering Parenting BEHAVIORAL

See Arm description.

Group A: Centering Parenting

Bright by Text BEHAVIORAL

See Arm description.

Group B: Bright by Text

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Mother smokes
• Mother works primarily at night
• Infant has metabolic or chromosomal disorders, chronic neurological or respiratory conditions, or developmental disability

Sponsors & Collaborators

• University of Texas at Austin: lead
• American Diabetes Association: collaborator

Study Sites (1)

CommUnity Care: North Central Health Center

Austin, Texas, 78758, United States

Location

Related Publications (8)

• Lavner JA, Stansfield BK, Beach SRH, Brody GH, Birch LL. Sleep SAAF: a responsive parenting intervention to prevent excessive weight gain and obesity among African American infants. BMC Pediatr. 2019 Jul 5;19(1):224. doi: 10.1186/s12887-019-1583-7.

  PMID: 31277694 BACKGROUND

• Baxter KA, Nambiar S, So THJ, Gallegos D, Byrne R. Parental Feeding Practices in Families Experiencing Food Insecurity: A Scoping Review. Int J Environ Res Public Health. 2022 May 5;19(9):5604. doi: 10.3390/ijerph19095604.

  PMID: 35564998 BACKGROUND

• Gross RS, Mendelsohn AL, Arana MM, Messito MJ. Food Insecurity During Pregnancy and Breastfeeding by Low-Income Hispanic Mothers. Pediatrics. 2019 Jun;143(6):e20184113. doi: 10.1542/peds.2018-4113. Epub 2019 May 14.

  PMID: 31088893 BACKGROUND

• Hall WA, Liva S, Moynihan M, Saunders R. A comparison of actigraphy and sleep diaries for infants' sleep behavior. Front Psychiatry. 2015 Feb 12;6:19. doi: 10.3389/fpsyt.2015.00019. eCollection 2015.

  PMID: 25729371 BACKGROUND

• Van Hoorn M, Feuling MB, Allen K, Berry R, Brown S, Sullivan CM, Goday PS. Evaluation and Management of Reduced Dietary Diversity in Children with Pediatric Feeding Disorder. J Autism Dev Disord. 2023 Mar;53(3):1290-1297. doi: 10.1007/s10803-022-05715-8. Epub 2022 Aug 22.

  PMID: 35996036 BACKGROUND

• Li X, Haneuse S, Rueschman M, Kaplan ER, Yu X, Davison KK, Redline S, Taveras EM. Longitudinal association of actigraphy-assessed sleep with physical growth in the first 6 months of life. Sleep. 2022 Jan 11;45(1):zsab243. doi: 10.1093/sleep/zsab243.

  PMID: 34676870 BACKGROUND

• Yalcin SS, Tezol O, Caylan N, Erat Nergiz M, Yildiz D, Cicek S, Oflu A. Evaluation of problematic screen exposure in pre-schoolers using a unique tool called "seven-in-seven screen exposure questionnaire": cross-sectional study. BMC Pediatr. 2021 Oct 25;21(1):472. doi: 10.1186/s12887-021-02939-y.

  PMID: 34696746 BACKGROUND

• Nadeau KJ, Anderson BJ, Berg EG, Chiang JL, Chou H, Copeland KC, Hannon TS, Huang TT, Lynch JL, Powell J, Sellers E, Tamborlane WV, Zeitler P. Youth-Onset Type 2 Diabetes Consensus Report: Current Status, Challenges, and Priorities. Diabetes Care. 2016 Sep;39(9):1635-42. doi: 10.2337/dc16-1066. Epub 2016 Aug 2.

  PMID: 27486237 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity; Infant Nutrition Disorders; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Megan J Gray, MD,MPH,FAAP

  University of Texas at Austin - Dell Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics and Population Health

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: November 7, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)