Sleep & Nutrition Education for Childhood Obesity

Overseen By Sara Dube, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Mother smokes, works nights, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

240 Participants Needed

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 willing to attend all study follow-up visits.

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.

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
• Centering Parenting

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.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Findings from Research

Out of 119 family-based interventions aimed at preventing childhood obesity, only 24 (20%) included strategies to promote child sleep, indicating that sleep promotion is currently underrepresented in these programs.

Most sleep-promoting interventions focused on educating parents about sleep hygiene and establishing bedtime routines, but only two studies examined sleep promotion independently, suggesting a need for more targeted research in this area.

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]

In a study of 109 children with overweight/obesity, parent-reported sleep-disordered breathing (SDB) symptoms were linked to increased behavioral and emotional issues, such as attention problems, depression, and anxiety.

Specifically, daytime sleepiness, a symptom of SDB, was associated with poorer adaptability and leadership skills, indicating that addressing SDB may improve emotional functioning in affected children.

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]

In a study of 528 infants followed from 4 to 60 months, longer nighttime sleep duration was linked to lower BMI z-scores, suggesting that adequate nighttime sleep may help prevent obesity in early childhood.

The research found that only nighttime sleep duration, not total or daytime sleep, was associated with healthier weight trajectories, highlighting the critical role of nighttime sleep in childhood development.

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]

In a study of 41 obese preschool-aged children enrolled in a weight management program, longer nocturnal sleep duration was linked to lower body mass index (BMI) after treatment, suggesting that better sleep may help reduce obesity in young children.

The research also found that increased sleep duration was associated with lower caloric intake, indicating that adequate sleep could play a crucial role in managing weight and eating habits in preschoolers.

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]

Children and adolescents with obesity reported shorter sleep duration and poorer sleep behaviors compared to their normal-weight peers, indicating a significant relationship between obesity and sleep quality.

Psychological factors such as anxiety and depression were found to be moderate predictors of unfavorable sleep outcomes, suggesting that these issues may need to be addressed in treatment programs for childhood obesity.

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]

The INSIGHT study, involving 279 mother-infant pairs, demonstrated that a responsive parenting intervention improved infant sleep behaviors, leading to shorter bedtime routines and earlier bedtimes at 16 and 40 weeks.

Infants in the RP group experienced longer nocturnal sleep durations by an average of 35, 25, and 22 minutes at 8, 16, and 40 weeks, respectively, indicating the intervention's effectiveness in promoting better sleep habits during infancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

A study involving 398 American Indian children aged 2-5 years found that longer overnight sleep duration is significantly associated with lower BMI z-scores, indicating a potential protective effect against obesity.

Children who slept 12 or more hours per night had significantly lower BMI z-scores compared to those who slept 8 to 10 hours or less than 8 hours, suggesting that adequate sleep may be an important factor in preventing obesity in this population.

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]

One-year-old children with a high risk of obesity, based on parental weight, exhibited poorer sleep patterns, including later bedtimes and longer time to fall asleep, compared to those with low obesity risk.

Child sleep patterns were significantly influenced by family obesity risk and parental sleep habits, indicating that improving parental sleep quality may benefit children's sleep and potentially their weight status.

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]

The study involved 91 families of pre-Kindergarten students in low-income urban communities and showed that an enhanced version of ParentCorps effectively improved parenting practices and reduced child behavior problems.

Children in the program exhibited increased knowledge about nutrition and physical activity, decreased television watching, and for boys, reduced sleep problems, highlighting the program's potential in preventing obesity in at-risk youth.

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]

Insufficient sleep in infancy and early childhood is linked to an increased risk of overweight and obesity, highlighting the importance of sleep duration in childhood health.

Interventions designed to improve sleep quality and quantity may be effective strategies for preventing childhood obesity, although more research is needed to fully understand the mechanisms involved.

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]

The study found that parents' education levels significantly influence their children's oral health and obesity rates, highlighting the importance of parental knowledge in promoting better health outcomes.

Obesity in children was identified as a potential risk factor for oral-related sleep disorders, such as snoring and sleep bruxism, indicating a link between physical health and oral health issues.

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]