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NCT03186508 · ClinicalTrials.gov registry record · NA
Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors-Renewal
A NA study of Obesity and Sleep, sponsored by Temple University.
- Completed
- Registry status
- NA
- Development phase
- 149
- Enrollment target
- 1
- Study location
NCT03186508: Completed NA study of Obesity and Sleep, sponsored by Temple University.
NCT03186508 is a NA study of Obesity and Sleep that has completed, run by Temple University. The registered enrollment target is 149 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03186508, a NA study of Obesity and Sleep, has completed, sponsored by Temple University.
- COMPLETED
- Registry status
- NA
- Development phase
- 149 participants
- Enrollment target
- 1
- Study location
Study Summary
Enhancing children's sleep may be a novel approach for prevention of obesity and cardiovascular (CV) disturbance. Observational studies with children demonstrate that short sleep increases risk of obesity and other CV risk factors. Randomized controlled trials with children 8-11 years old demonstrate that enhancing sleep duration leads to positive changes in eating and activity behaviors and weight status, particularly for children who enhance their sleep the most. Enhancing sleep may be particularly important for racial minority children and those from lower socioeconomic backgrounds given their increased risk for short sleep, obesity and CV risk factors. In this study two active obesity preventive interventions will be evaluated: a) enhancing sleep alone (Optimize Sleep \[OS\]), and b) enhancing sleep along with eating and activity behaviors that have demonstrated efficacy for obesity prevention and are implicated in self-regulatory pathways related to sleep (i.e., energy dense snack foods and beverages, TV viewing, and physical activity) (OS-Plus). Two hundred four children 6-11 years old who are primarily African American/black, primarily from low socioeconomic backgrounds, and who sleep \< 9.5 hours/night into a 12-month study will be enrolled. Children will be randomly assigned to either OS or OS-Plus. Over the 6-month treatment phase, all children will attend an 8-session treatment; monthly phone contacts will occur during maintenance (6-12 months). Primary aim is to determine the efficacy of OS-Plus relative to OS on change in body mass index z-score (BMIz) at end of treatment. Secondary aims will assess efficacy of OS-Plus relative to OS on additional cardiometabolic risk factors, eating and activity behaviors. Exploratory aims will assess maintenance of effects at 12 months.
Primary Outcome
change in body mass index z-score (accounting for child age and sex)
Interventions
- BEHAVIORAL Optimize Sleep (OS)
- BEHAVIORAL Optimize Sleep-Plus (OS-Plus)
Study Locations (1)
Pennsylvania
- Temple University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2018-02-28 |
| Est. Completion | 2023-09-19 |
| Phase | NA |
What the finished NCT03186508 record still lists
NCT03186508 is an interventional study that assigns participants to a tested intervention. The registered 149 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Optimize Sleep (OS) is the first listed.
NCT03186508 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03186508 about?
NCT03186508 is a clinical study titled "Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors-Renewal". Enhancing children's sleep may be a novel approach for prevention of obesity and cardiovascular (CV) disturbance. Observational studies with children demonstrate that short sleep increases risk of obesity and other CV risk factors. Randomized controlled trials with children 8-11 years old demonstrat...
What is the current status of trial NCT03186508?
This trial is currently completed. It is a NA study. The enrollment target is 149 participants. The study started on 2018-02-28. Estimated completion is 2023-09-19.
What conditions does trial NCT03186508 study?
This clinical trial studies the following conditions: Obesity, Sleep.
What interventions are being tested in trial NCT03186508?
The interventions under investigation include: Optimize Sleep (OS) (BEHAVIORAL), Optimize Sleep-Plus (OS-Plus) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03186508?
This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03186508 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03186508's enrollment target sits among peer trials
149 387th of 1053 higher than 666 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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