Behavioral Sleep Intervention for Childhood Obesity
(Rx SLEEP Trial)
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.12345Why 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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Families receive either a behavioral sleep intervention or sleep education over 6 months
Follow-up
Participants are monitored for changes in sleep, diet, physical activity, and weight status
What Are the Treatments Tested in This Trial?
Interventions
- Optimize Sleep Primary Care (OSPC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Temple University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator