Use of Fitbits During Breathing Meditation
Phase: NA
Conditions: Healthy
Sponsor: Winthrop University

TITLE: Use of Fitbits During Breathing Meditation 
NCT#: NCT5101343 
DATE: 2/15/2021 
Study Protocol with SAP and/or ICF 
 
Study Protocol 
Description 
College students are currently experiencing unprecedented stress during the COVID-19 
pandemic and a unique learning environment with many courses being taught online. 
Mindfulness practices and physical activity have previously been demonstrated to help reduce 
stress and anxiety among college students. This study will examine short breathing meditations 
paired with Fitbit technology in order to help students practice mindfulness and track physical 
activity. Measures including heart rate, physical activity, sleep patterns, as well as assessments 
of well-being and anxiety levels will be examined. Participants will be current undergraduate 
and graduate students at Winthrop University. The anticipated sample size is 20 subjects (10 in 
the experimental group and 10 in the control group). The anticipated sample size for interviews 
is 5 subjects. 
 
Design and Methods 
Participants will be divided into two groups – experimental and control group. 
The experimental group will spend two weeks wearing the Fitbit for as close to 24 hours each 
day (including during sleep), except when showering or charging the device. For the second 
week, participants will also use the Fitbit meditation app, Relax, to complete a 5-minute 
breathing meditation once a day, every day for one week. The Fitbit will measure physical 
activity and record physiological data. Following the two weeks, a subset of the experimental 
group will participate in semi-structured interviews to discuss their experience. 
 
The control group will wear the Fitbit for 2 weeks, but will not complete any meditation. They 
will be offered the opportunity to participate in the meditation activities after the study is 
complete. 
 
Participants will complete the HADS survey, MHC-SF survey, UMC Penn State Worry 
Questionnaire, and MAAS survey, at baseline and at the end of the second week of the program 
(please see attached for all surveys). They will also complete a pre-program survey at baseline 
and a post-program survey (including demographic information and experience with COVID-19) 
after the 2-week program (please see attached surveys). All surveys will be administered via 
email and completed via Qualtrics.   
 
Additionally, a subset of participants will be invited to complete semi-structured interviews 
with the research team about their experience (please see attached for interview questions). 
Each interview will have 6 questions, but the total number of questions may vary depending on 
the follow-up questions prompted by the subjects’ responses. The estimated time to complete 
the interview is 30 minutes. 
 

Statistical Analysis Plan (SAP) 
Survey data collected via Qualtrics (Provo, UT). Fitbit data downloaded from participants’ Fitbit 
accounts into Microsoft Excel for analysis. Statistical analysis using R (R Core Team, 2021, R 
Version 4.1.0, Vienna, Austria). Data combined across all three cohorts for all analysis. All data 
assessed for normality using the Shapiro-Wilk test, and p > 0.05 for all samples. Fisher's exact 
test used to analyze categorical variables (race, class, sex), and t-tests used to analyze 
continuous variables (age, BMI) between control and treatment groups in demographic data. 
Paired t-tests used to compare baseline/post-study survey data and week 2/week 1 Fitbit data, 
and t-tests used to compare control and treatment groups at each time point. All values are 
reported as mean ± standard deviation (SD). To examine the mean differences between groups, 
95% confidence intervals (CI) were used (Cumming, 2014).