Sleep & Nutrition Education for Childhood Obesity

Recruiting in Palo Alto (17 mi)

Overseen by Megan J Gray, MD,MPH,FAAP

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Texas at Austin

Disqualifiers: Mother smokes, works nights, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Bright by Text, Centering Parenting for childhood obesity?

Research shows that promoting good sleep habits in family-based programs can help reduce childhood obesity. Educating parents about sleep routines and limiting screen time are common strategies that have been used in similar interventions. ^{1 2 3 4 5}

Is the Sleep & Nutrition Education for Childhood Obesity treatment safe for children?

The interventions that include sleep promotion for childhood obesity, such as educating parents on sleep hygiene and bedtime routines, have been implemented safely in various settings like clinics and homes. These interventions are generally considered safe for children, as they focus on improving sleep habits and overall health. ^{1 6 7 8 9}

How does the Sleep & Nutrition Education treatment for childhood obesity differ from other treatments?

This treatment is unique because it focuses on improving sleep quality and quantity as a way to prevent childhood obesity, which is not commonly emphasized in other interventions. While most existing treatments target diet and physical activity, this approach highlights the role of sleep education and bedtime routines, making it a novel addition to obesity prevention strategies. ^{1 3 7 10 11}

Research Team

Megan J Gray, MD,MPH,FAAP

Principal Investigator

University of Texas at Austin - Dell Medical School

Eligibility Criteria

This trial is for Hispanic mothers over 18 with healthy, full-term infants under one month old who are patients of CommUnityCare. It's not for those who smoke, work mainly at night, or have babies with metabolic/chromosomal disorders, chronic neurological/respiratory conditions, or developmental disabilities.

Inclusion Criteria

My baby was born full term and is younger than 1 month.

The mother is of Latino/Hispanic ethnicity.

I am a mother and I am 18 years old or older.

Exclusion Criteria

The mother's primary work schedule is during the night.

The baby has certain medical conditions or disabilities.

The participant's mother is a smoker.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive community-embedded coaching on responsive feeding and sleep practices through group visits and text-based programs

22-24 months

8 group sessions, regular well-child checks

Follow-up

Participants are monitored for impact on infant feeding practices and sleep quality

2-4 months

Treatment Details

Interventions

• Bright by Text (Behavioral Intervention)
• Centering Parenting (Behavioral Intervention)

Trial Overview Project Sueño aims to prevent early obesity and metabolic syndrome by studying how support programs like Bright by Text and Centering Parenting can help mothers make better decisions about their baby's feeding and sleeping habits.

Participant Groups

Group I: Group A: Centering Parenting Experimental Treatment 1 Intervention

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 II: Group B: Bright by Text Active Control 1 Intervention

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 III: Group C: Standard of Care Active Control 1 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

CommUnity Care: North Central Health Center Austin, TX

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Patients Recruited

86,100+

American Diabetes Association

Collaborator

Trials

148

Patients Recruited

102,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inclusion of Sleep Promotion in Family-Based Interventions To Prevent Childhood Obesity. Agaronov, A., Ash, T., Sepulveda, M., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of Sleep-Related Outcomes with Behavioral and Emotional Functioning in Children with Overweight/Obesity. Torres-Lopez, LV., Cadenas-Sanchez, C., Migueles, JH., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nighttime sleep duration trajectories were associated with body mass index trajectories in early childhood. Zheng, M., Hesketh, KD., Wu, JHY., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between sleep duration and weight in treatment-seeking preschoolers with obesity. Clifford, LM., Beebe, DW., Simon, SL., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Childhood Obesity and Psychological Factors on Sleep. Mazurak, N., Cook, J., Weiland, A., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

INSIGHT Responsive Parenting Intervention and Infant Sleep. Paul, IM., Savage, JS., Anzman-Frasca, S., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overnight sleep duration and obesity in 2-5 year-old American Indian children. Ingram, DG., Irish, LA., Tomayko, EJ., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep differences in one-year-old children were related to obesity risks based on their parents' weight according to baseline longitudinal study data. Ekstedt, M., Darkeh, MH., Xiu, L., et al.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early childhood obesity prevention in low-income, urban communities. Dawson-McClure, S., Brotman, LM., Theise, R., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of short sleep duration with childhood obesity and weight gain: summary of a presentation to the National Academy of Science's Roundtable on Obesity Solutions. Ash, T., Taveras, EM.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between parent education level, oral health, and oral-related sleep disturbance. An observational crosssectional study. Minervini, G., Franco, R., Marrapodi, MM., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Inclusion of Sleep Promotion in Family-Based Interventions To Prevent Childhood Obesity. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Associations of Sleep-Related Outcomes with Behavioral and Emotional Functioning in Children with Overweight/Obesity. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Nighttime sleep duration trajectories were associated with body mass index trajectories in early childhood. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The association between sleep duration and weight in treatment-seeking preschoolers with obesity. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of Childhood Obesity and Psychological Factors on Sleep. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

INSIGHT Responsive Parenting Intervention and Infant Sleep. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Overnight sleep duration and obesity in 2-5 year-old American Indian children. [2022]

8. Norway pubmed.ncbi.nlm.nih.gov

Sleep differences in one-year-old children were related to obesity risks based on their parents' weight according to baseline longitudinal study data. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Early childhood obesity prevention in low-income, urban communities. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Associations of short sleep duration with childhood obesity and weight gain: summary of a presentation to the National Academy of Science's Roundtable on Obesity Solutions. [2022]

11. Italy pubmed.ncbi.nlm.nih.gov

The association between parent education level, oral health, and oral-related sleep disturbance. An observational crosssectional study. [2023]