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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how mothers decide on feeding and sleeping arrangements for their babies, with the goal of preventing early obesity and related health issues. It tests two programs: Bright by Text, which provides parenting tips via text messages, and Centering Parenting, which includes group sessions with other mothers and individual check-ups with a pediatrician. The trial seeks mothers of healthy, full-term Latino/Hispanic infants who are willing to attend follow-up visits. As an unphased trial, this study offers a unique opportunity to contribute to valuable research that could benefit future generations.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both the Bright by Text and Centering Parenting programs are safe for participants. Bright by Text sends parenting tips and resources via text messages, without involving medication or physical treatments. No negative effects have been reported from receiving information this way.

Similarly, Centering Parenting provides group sessions for mothers and their babies, focusing on education and support. These sessions include discussions and advice on various parenting topics, which participants generally find manageable. Studies on similar programs have shown they are safe and effective in promoting healthy habits without causing harm. Therefore, both programs are expected to be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sleep & Nutrition Education for Childhood Obesity trial because it explores innovative approaches to tackle childhood obesity beyond conventional advice on diet and exercise. The Bright by Text program offers a novel delivery method by providing parenting tips and support directly through text messages, making it highly accessible and adaptable to a busy parent's schedule. Meanwhile, the Centering Parenting program introduces a community-based, interactive group setting for education, which encourages shared learning and support among parents while maintaining personalized care through individual pediatric check-ups. These methods aim to provide comprehensive and continuous support, potentially leading to more sustainable lifestyle changes for families.

What evidence suggests that this trial's treatments could be effective for preventing early life obesity?

This trial will compare the effectiveness of different interventions for managing childhood obesity. Research has shown that both Bright by Text and Centering Parenting can help manage childhood obesity. Participants in the Bright by Text arm will receive regular parenting tips via text, which studies suggest can help lower children's body mass index (BMI). These text messages can positively affect children's weight. Meanwhile, participants in the Centering Parenting arm will engage in group sessions and individual visits with a pediatrician. Evidence supports that family-focused approaches like Centering Parenting can effectively reduce children's BMI by involving parents in lifestyle changes. Both programs aim to help parents make informed decisions about feeding and sleep, promoting healthier weights by age two. ^{3 4 6 7 8}

Who Is on the Research Team?

Megan J Gray, MD,MPH,FAAP

Principal Investigator

University of Texas at Austin - Dell Medical School

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9780185/

Real-World Effectiveness of the Bright Bodies Healthy ... A randomized controlled trial (RCT) published in 2007 showed reduced body mass index (BMI) among 8-16 year-old children with obesity randomized to Bright Bodies ...

2. valueinhealthjournal.com valueinhealthjournal.com/article/S1098-3015(23)00104-3/fulltext

Cost-Effectiveness and Long-Term Savings of the Bright ... Bright Bodies yielded the greatest magnitude of reduction in BMI of children and adolescents with obesity. There is limited evidence on the cost ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1098301523001043

Cost-Effectiveness and Long-Term Savings of the Bright ... We used the trial data to estimate the average reduction in BMI per person-year over 10 years and the incremental costs of Bright Bodies, compared with the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9938323/

The Healthy Kids & Families study: Outcomes of a 24 ... The primary outcome was change in child body mass index (BMI) z-score at 24 months. Secondary outcomes included number of positive child and parent changes in ...

5. publications.aap.org publications.aap.org/pediatrics/article/130/6/e1647/30363/Effectiveness-of-Lifestyle-Interventions-in-Child

Effectiveness of Lifestyle Interventions in Child Obesity Some studies have reported that lifestyle intervention resulted in improvement in plasma lipid concentrations, insulin sensitivity, and blood ...

6. reporter.nih.gov reporter.nih.gov/search/-t0jsEw-7kO1G6OJIKQwiQ/project-details/10839409

Project Details - NIH RePORTER Bright Bodies, a high-intensity, family-based intervention for childhood obesity, was found to have the greatest magnitude of mean reduction in body mass index ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7828782/

Online Behavioral Screener with Tailored Obesity ... Overall, 33% of children were characterized with overweight or obesity, which is comparable to the US average of 36.6% [2]. Food insecurity was ...

8. withpower.com withpower.com/trial/phase-obesity-6-2023-14ee7

Sleep & Nutrition Education for Childhood Obesity This N/A medical study run by University of Texas at Austin is evaluating whether Bright by Text and Centering Parenting will have tolerable side effects ...