Physical Activity Clinical Trial
— MB-CollegeOfficial title:
Mindfulness-Based College: Stage 1 Randomized Controlled Trial for Emerging Adult Well-Being
Verified date | June 2019 |
Source | Brown University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 96 |
Est. completion date | September 9, 2018 |
Est. primary completion date | September 9, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 28 Years |
Eligibility |
Inclusion Criteria: (1) 18-28 years of age; (2) Currently matriculated undergraduate
students at any university; and (3) Able to read, write, and speak in English Exclusion Criteria: (1) Current regular meditation practice (>once/week); (2) Serious medical illness precluding regular class attendance; (3) Current substance abuse, suicidal ideation or eating disorder; and (4) History of bipolar or psychotic disorders or self-injurious behaviors. |
Country | Name | City | State |
---|---|---|---|
United States | Brown University School of Public Health | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Brown University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Self-Awareness | Multidimensional Assessment of Interoceptive Awareness: 32-item measure | Baseline, 3-month, 6-month | |
Secondary | Attention Control | Sustained Attention to Response Task: a computerized go/no-go task that evaluates sustained attention, response inhibition as well as self-regulation. | Baseline, 3-month, 6-month | |
Secondary | Self-Compassion | Self-Compassion Scale- short form: 12 item version and evaluate both a total score as well as six sub-scales of self-compassion: Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness, and Over-Identification. | Baseline, 3-month, 6-month |
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