NCT03124446

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2018

Completed
Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

2 years

First QC Date

April 14, 2017

Last Update Submit

June 10, 2019

Conditions

Diet HabitPhysical ActivitySleepLonelinessEmotional RegulationAlcohol Consumption, YouthStress, Psychological

Keywords

mindfulness, meditation, emerging adults, young adults, undergraduate students, stress, health

Outcome Measures

Primary Outcomes (1)

  • Health Summary Score

    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 per night); perceived stress (validated Perceived Stress Scale score); and loneliness (validated R-UCLA Loneliness Scale score). Secondary analyses will evaluate which of the seven domains are most driving associations. Further secondary analyses will determine if participant-identified health domains to focus on showed improvements in MB-College vs. control, restricting only to health domains identified by participants as having high readiness to change.

    Baseline, 3-month, 6-month

Secondary Outcomes (3)

  • Self-Awareness

    Baseline, 3-month, 6-month

  • Attention Control

    Baseline, 3-month, 6-month

  • Self-Compassion

    Baseline, 3-month, 6-month

Study Arms (2)

Mindfulness-Based College

EXPERIMENTAL

MB-College is an 8-week, 9-session curriculum providing systematic and intensive training in mindfulness meditation practices, applied to health behaviors relevant to college students. The curriculum is based on the manualized and standardized Mindfulness-Based Stress Reduction. The course builds a foundation of mindfulness self-regulation skills, including attention control, self-awareness and emotion regulation. It then directs those skills towards participants' relationships with health-related factors particularly salient in college undergraduates, including physical activity, diet, alcohol consumption, sleep, stress, social relationships, cognitive performance, and emotion regulation. Health behavior goal setting, and support for behavior change are integrated in the curriculum.

Behavioral: Mindfulness-Based College

Enhanced Usual Care Control

ACTIVE COMPARATOR

Participants in the enhanced usual care control group were spoken with by trained study staff, and as part of the enhanced usual care, were offered a referral to the study's psychiatrist and University counseling resources, if anxiety, depression, or suicidal ideation levels at baseline or follow-up reached clinical levels on the Beck Anxiety Inventory or the Revised Centers for Epidemiologic Studies Depression (CESD-R) scale. Participants in the control group were eligible to take the MB-College program during the following university term.

Behavioral: Enhanced Usual Care Control

Interventions

Mindfulness-Based CollegeBEHAVIORAL

MB-College is an 8-week, 9-session curriculum providing systematic and intensive training in mindfulness meditation practices, applied to health behaviors relevant to college students. The curriculum is based on the manualized and standardized Mindfulness-Based Stress Reduction. The course builds a foundation of mindfulness self-regulation skills, including attention control, self-awareness and emotion regulation. It then directs those skills towards participants' relationships with health-related factors particularly salient in college undergraduates, including physical activity, diet, alcohol consumption, sleep, stress, social relationships, cognitive performance, and emotion regulation. Health behavior goal setting, and support for behavior change are integrated in the curriculum.

Mindfulness-Based College
Enhanced Usual Care ControlBEHAVIORAL

Participants in the enhanced usual care control group were spoken with by trained study staff, and as part of the enhanced usual care, were offered a referral to the study's psychiatrist and University counseling resources, if anxiety, depression, or suicidal ideation levels at baseline or follow-up reached clinical levels on the Beck Anxiety Inventory or the Revised Centers for Epidemiologic Studies Depression (CESD-R) scale. Participants in the control group were eligible to take the MB-College program during the following university term.

Enhanced Usual Care Control

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02912, United States

Location

Related Publications (3)

  • Nardi WR, Elshabassi N, Spas J, Zima A, Saadeh F, Loucks EB. Students experiences of an 8-week mindfulness-based intervention at a college of opportunity: a qualitative investigation of the mindfulness-based college program. BMC Public Health. 2022 Dec 13;22(1):2331. doi: 10.1186/s12889-022-14775-5.

    PMID: 36514082DERIVED

  • Nardi WR, Harrison A, Saadeh FB, Webb J, Wentz AE, Loucks EB. Mindfulness and cardiovascular health: Qualitative findings on mechanisms from the mindfulness-based blood pressure reduction (MB-BP) study. PLoS One. 2020 Sep 23;15(9):e0239533. doi: 10.1371/journal.pone.0239533. eCollection 2020.

    PMID: 32966308DERIVED

  • Loucks EB, Nardi WR, Gutman R, Saadeh FB, Li Y, Vago DR, Fiske LB, Spas JJ, Harrison A. Mindfulness-Based College: A Stage 1 Randomized Controlled Trial for University Student Well-Being. Psychosom Med. 2021 Jul-Aug 01;83(6):602-614. doi: 10.1097/PSY.0000000000000860.

    PMID: 32947581DERIVED

MeSH Terms

Conditions

Feeding BehaviorMotor ActivityEmotional RegulationUnderage DrinkingStress, Psychological

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorSelf-ControlSocial BehaviorAdolescent BehaviorAlcohol DrinkingDrinking BehaviorBehavioral Symptoms

Study Officials

  • Eric B Loucks, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Data analysts will be blinded to treatment allocation and randomization.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Overall, a superiority randomized controlled trial with parallel groups will be performed with 30 participants per arm. Participants will be randomly assigned to MB-College or enhanced usual care control.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 21, 2017

Study Start

September 1, 2016

Primary Completion

September 9, 2018

Study Completion

September 9, 2018

Last Updated

June 12, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

Personally de-identified data will be made available to researchers with IRB approval.

Locations

US(1)