Project Sueño: Sleep & Understanding Early Nutrition in Obesity

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117631
• Other study ID #: STUDY00003961
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: University of Texas at Austin
• Contact: Megan J Gray, MD,MPH,FAAP
• Phone: 512-495-3002
• Email: megan.gray[@]austin.utexas.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus Risk
• Infant Development
• Infant Nutrition Disorders
• Infant Obesity
• Infant Overnutrition
• Metabolic Syndrome
• Obesity
• Overnutrition
• Overweight
• Pediatric Obesity

Intervention

Behavioral:
• Centering Parenting
See Arm description.
• Bright by Text
See Arm description.

Locations

Country	Name	City	State
United States	CommUnity Care: North Central Health Center	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	American Diabetes Association

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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