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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 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.

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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.

Interventions

  • BEHAVIORAL Mindfulness-Based College
  • BEHAVIORAL Enhanced Usual Care Control

Study Locations (1)

Rhode Island

  • Brown University School of Public Health - Providence

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2016-09-01
Est. Completion 2018-09-09
Phase NA

Sponsor

Brown University

231 total trials

What the Registry Record Tells You About NCT03124446

The ClinicalTrials.gov registry entry for NCT03124446 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,165-participant average among 151 other Sleep trials with a reported enrollment target (98% lower). The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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