Study Summary
This trial will evaluate if enhancing sleep, either alone or along with other activities that impact self-regulatory pathways related to sleep, can help prevent obesity in children.
Eligible Conditions
- Sleep
- Obesity
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 11 Secondary · Reporting Duration: Change from baseline in MVPA at 6 months
Month 6
Change in BMIz
Month 6
Change in Insulin Resistance
Month 6
Change in Insulin Sensitivity Index (ISI)
Month 6
Change in Blood Glucose Levels
Month 6
Change in Eating in the Absence of Hunger (EAH)
Month 6
Change in Percent Time spent in Moderate to Vigorous Physical Activity (MVPA)
Month 6
Change in Non-HDL cholesterol (non-HDL-C)
Month 6
Change in Caloric Intake
Month 6
Change in Food Reinforcement
Month 6
Change in Sleep Period
Month 6
Change in Body Composition
Month 6
Change in Waist Circumference
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Optimize Sleep (OS)
1 of 2
Optimize Sleep-Plus (OS-Plus)
1 of 2
Active Control
204 Total Participants · 2 Treatment Groups
Primary Treatment: Optimize Sleep (OS) · No Placebo Group · N/A
Optimize Sleep (OS)
Behavioral
ActiveComparator Group · 1 Intervention: Optimize Sleep (OS) · Intervention Types: BehavioralOptimize Sleep-Plus (OS-Plus)
Behavioral
ActiveComparator Group · 1 Intervention: Optimize Sleep-Plus (OS-Plus) · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline in mvpa at 6 months
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,588 Previous Clinical Trials
46,945,498 Total Patients Enrolled
30 Trials studying Sleep
56,965 Patients Enrolled for Sleep
National Institutes of Health (NIH)NIH
2,441 Previous Clinical Trials
24,567,333 Total Patients Enrolled
4 Trials studying Sleep
1,102 Patients Enrolled for Sleep
Temple UniversityLead Sponsor
269 Previous Clinical Trials
74,171 Total Patients Enrolled
4 Trials studying Sleep
713 Patients Enrolled for Sleep
Chantelle N Hart, PhDPrincipal InvestigatorTemple University
1 Previous Clinical Trials
37 Total Patients Enrolled
1 Trials studying Sleep
37 Patients Enrolled for Sleep
Eligibility Criteria
Age 6 - 11 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are 18 years of age or older.
You are a caregiver of a child aged 6-11 years.
You have 9 or more hours of sleep every day.\n
You are able to understand and complete the protocol.
You like food that is used in the eating regulation paradigms.
References
- Spaeth, Andrea M., Nicola L. Hawley, Hollie A. Raynor, Elissa Jelalian, Ashley Greer, Scott E. Crouter, Donna L. Coffman, et al.. 2019. “Sleep, Energy Balance, and Meal Timing in School-aged Children”. Sleep Medicine. Elsevier BV. doi:10.1016/j.sleep.2019.02.003.
- 2018. "Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors-Renewal". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03186508.
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Conditions
Cancer Related
Treatments