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NCT03124446 · ClinicalTrials.gov registry record · NA
Mindfulness-Based College: Stage 1
A NA study of Sleep and Physical Activity, sponsored by Brown University.
- Completed
- Registry status
- NA
- Development phase
- 96
- Enrollment target
- 1
- Study location
NCT03124446: Completed NA study of Sleep and Physical Activity, sponsored by Brown University.
NCT03124446 is a NA study of Sleep and Physical Activity that has completed, run by Brown University. The registered enrollment target is 96 participants, below the 4,165-participant average among 151 other Sleep trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03124446, a NA study of Sleep and Physical Activity, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- NA
- Development phase
- 96 participants
- Enrollment target
- 1
- Study location
Study Summary
Mindfulness interventions are increasingly offered to undergraduate students at universities world-wide, however the evidence base is very limited. The objective is to evaluate effects of a customized mindfulness intervention (called Mindfulness-Based College) on undergraduate student health. A superiority randomized controlled trial with parallel groups will be performed with 30 participants in each arm. Participants will be randomly assigned to Mindfulness-Based College or health education waitlist control. Investigators will be blinded to treatment allocation. Participants will be assessed at baseline, 10 weeks, and six months. The primary outcome is a college health summary score, including seven evidence-based determinants of health particularly relevant to college student well-being: body mass index, physical activity, diet, alcohol consumption, sleep quantity, perceived stress, and loneliness. Primary intention-to-treat analyses will evaluate whether MB-College vs. control is associated with the summary score, utilizing generalized linear models. Secondary analyses will evaluate which, if any, of the seven determinants of health are driving associations.
Primary Outcome
The primary outcome is change in a college health summary score from baseline to 6 months follow-up, assessed using the following 7 evidence-based determinants of health relevant to college student well-being: body mass index; physical activity (MET minutes and step counts per week, using validated actigraphy and IPAQ); diet (mean daily fruit and vegetable consumption, utilizing validated food frequency questionnaire); alcohol consumption (mean drinks per day); sleep quantity (mean sleep hours p
Conditions Studied
Interventions
- BEHAVIORAL Mindfulness-Based College
- BEHAVIORAL Enhanced Usual Care Control
Study Locations (1)
Rhode Island
- Brown University School of Public Health - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2016-09-01 |
| Est. Completion | 2018-09-09 |
| Phase | NA |
What the finished NCT03124446 record still lists
NCT03124446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 4,165-participant average among 151 other Sleep trials with a reported enrollment target (98% lower).
The record links to 7 conditions, with Sleep appearing as the primary indexed condition, and to 2 interventions - of which Mindfulness-Based College is the first listed.
NCT03124446 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT03124446 about?
NCT03124446 is a clinical study titled "Mindfulness-Based College: Stage 1". Mindfulness interventions are increasingly offered to undergraduate students at universities world-wide, however the evidence base is very limited. The objective is to evaluate effects of a customized mindfulness intervention (called Mindfulness-Based College) on undergraduate student health. A supe...
What is the current status of trial NCT03124446?
This trial is currently completed. It is a NA study. The enrollment target is 96 participants. The study started on 2016-09-01. Estimated completion is 2018-09-09.
What conditions does trial NCT03124446 study?
This clinical trial studies the following conditions: Sleep, Physical Activity, Stress, Psychological, Loneliness, Diet Habit.
What interventions are being tested in trial NCT03124446?
The interventions under investigation include: Mindfulness-Based College (BEHAVIORAL), Enhanced Usual Care Control (BEHAVIORAL).
Who is sponsoring clinical trial NCT03124446?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03124446 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sleep
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03124446's enrollment target sits among peer trials
96 70th of 151 higher than 81 of 151 other Sleep trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep 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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