50 Participants Needed

Behavioral Sleep Intervention for Childhood Obesity

(Rx SLEEP Trial)

AO
CN
Overseen ByChantelle N Hart, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Temple University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to help children aged 6-11 improve sleep to address obesity. One group will work directly with a nurse to learn effective sleep strategies through the Optimize Sleep Primary Care (OSPC) program, while the other will receive educational materials about the benefits of a good night's sleep. Families will participate in assessments to track progress, including questionnaires, sleep and activity monitoring, and dietary reports. This trial suits families whose children sleep less than 9 hours a night and have a Body Mass Index (BMI) within a specific range. As an unphased trial, this study offers families the chance to contribute to valuable research that could enhance children's health and well-being.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes participants who use medications that may impact sleep or weight status.

What prior data suggests that these sleep interventions are safe for children?

Research has shown that behavioral sleep programs for children are generally safe and well-tolerated. These programs aim to improve sleep habits and routines without medication or other medical treatments. Studies have not reported significant negative effects from similar methods.

In this trial, children will either work with nurses to improve their sleep or learn about the benefits of good sleep. Both approaches emphasize guidance and education rather than physical treatments, reducing the chance of side effects.

Although specific data on negative effects for this type of program is lacking, the nature of the treatment suggests it is safe for children. Parents considering this trial can feel reassured that the focus is on improving sleep behavior, which is typically a low-risk approach.12345

Why are researchers excited about this trial?

Unlike traditional treatments for childhood obesity, which often focus on diet and exercise, the Behavioral Sleep Intervention targets sleep patterns to help manage weight. Researchers are excited about this approach because it emphasizes optimizing sleep as a critical component of a healthy lifestyle, potentially leading to more sustainable weight management. By enhancing sleep quality, this intervention may also improve children's overall well-being and energy levels, distinguishing it from standard options that don't address sleep directly.

What evidence suggests that this trial's treatments could be effective for childhood obesity?

Research shows that improving sleep can help manage childhood obesity. In this trial, researchers will assign participants to one of two groups. One group will receive the Optimize Sleep Primary Care (OSPC) intervention, which aims to improve both sleep quality and duration for children. The other group will receive Sleep Education, which includes advice on sleep, diet, and exercise. Previous studies found that when nurses helped children sleep better, the kids achieved healthier weights. Additionally, research suggests that good sleep habits play a key role in preventing and managing obesity in children, as evidenced by improvements in BMI (Body Mass Index) percentiles.12367

Who Is on the Research Team?

CN

Chantelle N Hart, PhD

Principal Investigator

Temple University

Are You a Good Fit for This Trial?

This trial is for children aged 6-11 who sleep less than 9 hours most nights, have a BMI between the 10th and 95th percentile for their age and sex, and are patients at Temple Pediatrics. Their parents must be over 18, primary caregivers, willing to follow the study's procedures, and open to being randomly assigned to one of two groups.

Inclusion Criteria

I am a patient at Temple Pediatrics.
My child sleeps less than 9 hours most nights.
My child is between 6 and 11 years old.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Families receive either a behavioral sleep intervention or sleep education over 6 months

6 months
6 sessions (combination of in-person, virtual, and phone follow-ups)

Follow-up

Participants are monitored for changes in sleep, diet, physical activity, and weight status

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Optimize Sleep Primary Care (OSPC)
Trial Overview The study compares two methods aimed at improving children's sleep: personalized coaching from a nurse on behavioral strategies or receiving educational materials about good sleep practices. Families will engage in six sessions with assessments at the start, after two months, and six months including questionnaires, activity monitoring devices worn by children, dietary reports, and height/weight measurements.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Sleep EducationExperimental Treatment1 Intervention
Group II: Behavioral Sleep InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials
321
Recruited
89,100+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Published Research Related to This Trial

Family-based behavioral interventions are effective and safe for treating childhood obesity and should be prioritized as a first-line treatment option.
Primary care providers play a crucial role in identifying childhood obesity early and referring families to evidence-based treatments, emphasizing the importance of comprehensive, family-involved strategies for successful long-term management.
Current approaches to the management of pediatric overweight and obesity.Coppock, JH., Ridolfi, DR., Hayes, JF., et al.[2021]
In a study of 83 obese adolescents, those who reported getting more sleep during the week were more likely to experience a reduction in BMI after 3 months in a weight management program.
Adolescents who lost at least 1 kg/m² in BMI reported an average of 60.7 hours of sleep per week, compared to 56.4 hours for those with less weight loss, suggesting that improving sleep duration could be beneficial for weight management.
Longer weekly sleep duration predicts greater 3-month BMI reduction among obese adolescents attending a clinical multidisciplinary weight management program.Sallinen, BJ., Hassan, F., Olszewski, A., 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.
Impact of Childhood Obesity and Psychological Factors on Sleep.Mazurak, N., Cook, J., Weiland, A., et al.[2021]

Citations

Brief Behavioral Sleep Intervention for Obesity Prevention ...The goal of this study is to compare two different approaches to help families with children 6-11 years enhance nighttime sleep: 1) working one-on-one with ...
A Pediatric Primary Care Practice-based Obesity Intervention ...Of the children, 26.8% were overweight, 55.4% obese, and 17.8% severely obese. Mean (SD) age was 10.5 (1.4), 47.5% were female. BMI percentile improved in both ...
Behavioral Sleep Intervention for Childhood ObesityThe Optimize Sleep Primary Care (OSPC) treatment is unique because it focuses on improving sleep quality and duration as a way to prevent and manage childhood ...
Optimizing intervention components for sleep promotion in ...This paper presents the protocol for a randomized optimization trial using the Multiphase Optimization Strategy (MOST) to develop a mobile health platform.
Primary Care Can Succeed in Treating Childhood Obesity ...The program included both the children themselves and a legal guardian for a year, and it offered advice on diet, physical activity, and sleep.
Inclusion of Sleep Promotion in Family-Based Interventions To ...Out of 119 eligible family-based interventions to prevent childhood obesity, 24 (20%) promoted child sleep. In contrast, 106 (89%) interventions targeted diet, ...
Implementing an Electronic Health Record–Integrated ...During implementation and across age groups, 9.7% of patients endorsed snoring, 12.2% sleep problems, and 34.4% insufficient sleep, and 6.5% of ...
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