Project Sueño: Sleep & Understanding Early Nutrition in Obesity

NCT ID: NCT06117631

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Centering Parenting

Intervention Type: BEHAVIORAL

See Arm description.

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.

Group Type: ACTIVE_COMPARATOR

Bright by Text

Intervention Type: BEHAVIORAL

See Arm description.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Centering Parenting

See Arm description.

Intervention Type: BEHAVIORAL

Bright by Text

See Arm description.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Megan Gray

Associate Professor of Pediatrics and Population Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Megan J Gray, MD,MPH,FAAP

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin - Dell Medical School

Locations

CommUnity Care: North Central Health Center

Austin, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Megan J Gray, MD,MPH,FAAP

Role: CONTACT

megan.gray@austin.utexas.edu

512-495-3002

Sara Dube, MPH

Role: CONTACT

sara.dube@austin.utexas.edu

512-471-0941

Facility Contacts

Megan Gray, MD, MPH, FAAP

Role: primary

megan.gray@austin.utexas.edu

512-495-3002

References

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.

Reference Type: BACKGROUND

PMID: 31277694 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35564998 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31088893 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25729371 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35996036 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34676870 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34696746 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27486237 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00003961

Identifier Type: -

Identifier Source: org_study_id