Clinical trial NCT06117631: Project Sueño: Sleep & Understanding Early Nutrition in Obesity
Official title: First Thousand Days: Prevention of Early Life Obesity in Latino Infants and Toddlers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2023-11-07
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess impact of group-based parent support coaching on infant feeding practices in first 2 years of child's life.
timeFrame: 2- to 24-months of infant age
measure: Assess impact of text-based parent support coaching on infant feeding practices in first 2 years of child's life.
timeFrame: 2- to 24-months of infant age
measure: Assess impact of group-based parent support coaching in first 2 years of child's life on responsive feeding and healthy sleep practices.
timeFrame: 2- to 24-months of infant age
measure: Assess impact of text-based parent support coaching in first 2 years of child's life on responsive feeding and healthy sleep practices.
timeFrame: 2- to 24-months of infant age
measure: Determine how parent support coaching and other predictors relate to infant and toddler growth in Latino children in first 2 years of life.
timeFrame: 2- to 24-months of infant age
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CommUnity Care: North Central Health Center
state: Texas
Study officials:
affiliation: University of Texas at Austin - Dell Medical School
name: Megan J Gray, MD,MPH,FAAP
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.
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.
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.
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.