HealthyNCT05101343

Use of Fitbits During Breathing Meditation

A study testing Breathing meditation in people with Healthy, run by Winthrop University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will examine short breathing meditations paired with Fitbit technology in order to assess 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Breathing meditation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2021to 6 Oct 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Older than 18 years.
Currently a student, faculty, or staff member at university where research is being completed.
Able to wear a Fitbit close to 24 hours a day for two weeks.

Who cannot join

Younger than 18 years.
Has previously practiced meditation.

Trial locations and contacts

1 site in 1 country.

United States1 site

Winthrop University
Rock Hill, South Carolina, 29733

Other trials in United States

About this study

Conditions: Healthy
Being tested: Breathing meditation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Breathing meditationBehavioural
Daily, 5-minute breathing meditation for one week.

Study groups in NCT05101343
Study group	Role	What they receive
Control	No intervention	Uses Fitbit, does not participate in breathing meditation.
Meditation	Experimental	Uses Fitbit and participates in brief, daily breathing meditation. Receives: Behavioral: Breathing meditation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Mindfulness
Mindful Attention Awareness Scale (MAAS.) The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness,namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. The survey consists of 15 questions using a Likert scale. Responses range from 1 (Almost Always) to 6 (Almost Never.)The scale is scored by computing a mean of the 15 items on the questionnaire. Score ranges of 15 (low) to 90 (high.) A higher score indicates a higher level of dispositional mindfulness.
Measured: Baseline and 2 weeks post-baseline
Change in Anxiety
Hospital Anxiety and Depression Scale (HADS). This questionnaire is used to measure anxiety and depression. Scale ranges are from 0 to 3. Lower values represent a better outcome. Total scores for depression and anxiety are summed. A score of 0-7 = normal. A score of 8-10 = borderline abnormal (borderline case.) A score of 11-21 = abnormal (case.)
Measured: Baseline and 2 weeks post-baseline
Change in Well-being
Mental Health Continuum Short Form (MHC-SF.) This questionnaire measures emotional, psychological, and social well-being. It consists of 14 questions scored on a Likert scale ranging from 0-5. Items 1-3 indicate emotional well-being (range 0-15). Items 4-8 indicate social well-being (0-25). Items 9-14 indicate psychological well-being (0-30). Total well-being score as reported here was calculated by adding the three sub-scores together (range 0-70). Higher scores indicate higher well-being for subscales and total well-being.
Measured: Baseline and 2 weeks post-baseline
Change in Worry
UMC (University Medical Centre) Penn State Worry Questionnaire. This is a 16 item questionnaire. Scale ranges from 0 (Not Typical at All) to 4 (Very Typical.) A higher score indicates a higher propensity for worry.
Measured: Baseline and 2 weeks post-baseline
Change in Depression
Hospital Anxiety and Depression Scale (HADS). This questionnaire is used to measure anxiety and depression. Scale ranges are from 0 to 3. Lower values represent a better outcome. Total scores for depression and anxiety are summed. A score of 0-7 = normal. A score of 8-10 = borderline abnormal (borderline case.) A score of 11-21 = abnormal (case.)
Measured: Baseline and 2 weeks post-baseline

Secondary outcomes (4)

Change in Sleep Minutes
Duration of sleep in minutes as measured using Fitbit. An increase in duration of sleep indicated improvement.
Measured: Baseline and 2 weeks
Change in Heart Rate
Changes in heart rate in beats per minute as measured by Fitbit (average observed heart rate during Week 2 minus the average heart rate observed during Week 1)
Measured: Baseline and 2 weeks
Change in Steps
Change in number of steps taken as measured by Fitbit (average number of steps taken during Week 2 minus the average number of steps taken during Week 1)
Measured: Baseline and 2 weeks
Change in Physically Active Minutes
Amount of time spent being physically active in minutes as reported by Fitbit. An increase in time spent being physically active indicated improvement.
Measured: Baseline and 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20216 Oct 2021

First posted1 Nov 2021
Study start1 Mar 2021
Primary completion6 Oct 2021
Study completion6 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05101343
Sponsor's protocol ID: IRB21074
Other IDs: P20GM103499-20, P217A180094
Status last verified: Jul 2024
First submitted: 15 Sep 2021
Last updated: 8 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Fitbits During Breathing Meditation
ClinicalTrials.gov ID: NCT05101343
Acronym / sponsor ID: IRB21074
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Winthrop UniversityUniversity, hospital or other
Collaborators: National Institute of General Medical Sciences (NIGMS)
Study start: 1 Mar 2021 (actual)
Primary completion: 6 Oct 2021 (actual)
Study completion: 6 Oct 2021 (actual)
First posted: 1 Nov 2021 (actual)
Results: Posted 8 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–Uses Fitbit, does not participate in breathing meditation.
Meditation	Experimental	Behavioral: Breathing meditationUses Fitbit and participates in brief, daily breathing meditation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Older than 18 years.
Currently a student, faculty, or staff member at university where research is being completed.
Able to wear a Fitbit close to 24 hours a day for two weeks.

Key exclusion criteria (2 listed)

Younger than 18 years.
Has previously practiced meditation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Breathing meditationDaily, 5-minute breathing meditation for one week.	Behavioural	Meditation

Primary outcome

Change in Mindfulness
Time frame: Baseline and 2 weeks post-baseline
Mindful Attention Awareness Scale (MAAS.) The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness,namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. The survey consists of 15 questions using a Likert scale. Responses range from 1 (Almost Always) to 6 (Almost Never.)The scale is scored by computing a mean of the 15 items on the questionnaire. Score ranges of 15 (low) to 90 (high.) A higher score indicates a higher level of dispositional mindfulness.
Change in Anxiety
Time frame: Baseline and 2 weeks post-baseline
Hospital Anxiety and Depression Scale (HADS). This questionnaire is used to measure anxiety and depression. Scale ranges are from 0 to 3. Lower values represent a better outcome. Total scores for depression and anxiety are summed. A score of 0-7 = normal. A score of 8-10 = borderline abnormal (borderline case.) A score of 11-21 = abnormal (case.)
Change in Well-being
Time frame: Baseline and 2 weeks post-baseline
Mental Health Continuum Short Form (MHC-SF.) This questionnaire measures emotional, psychological, and social well-being. It consists of 14 questions scored on a Likert scale ranging from 0-5. Items 1-3 indicate emotional well-being (range 0-15). Items 4-8 indicate social well-being (0-25). Items 9-14 indicate psychological well-being (0-30). Total well-being score as reported here was calculated by adding the three sub-scores together (range 0-70). Higher scores indicate higher well-being for subscales and total well-being.
Change in Worry
Time frame: Baseline and 2 weeks post-baseline
UMC (University Medical Centre) Penn State Worry Questionnaire. This is a 16 item questionnaire. Scale ranges from 0 (Not Typical at All) to 4 (Very Typical.) A higher score indicates a higher propensity for worry.
Change in Depression
Time frame: Baseline and 2 weeks post-baseline
Hospital Anxiety and Depression Scale (HADS). This questionnaire is used to measure anxiety and depression. Scale ranges are from 0 to 3. Lower values represent a better outcome. Total scores for depression and anxiety are summed. A score of 0-7 = normal. A score of 8-10 = borderline abnormal (borderline case.) A score of 11-21 = abnormal (case.)

4 secondary outcomes

Change in Sleep Minutes
Time frame: Baseline and 2 weeks
Change in Heart Rate
Time frame: Baseline and 2 weeks
Change in Steps
Time frame: Baseline and 2 weeks
Change in Physically Active Minutes
Time frame: Baseline and 2 weeks

Results and safety

Results posted to the registry on 8 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	19	17
Meditation	18	17

Primary outcome: Change in Mindfulness

Time frame: Baseline and 2 weeks post-baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Control n = 17	Meditation n = 17
Value	-0.08 (0.57)	0.1 (0.43)

Primary outcome: Change in Anxiety

Time frame: Baseline and 2 weeks post-baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Control n = 17	Meditation n = 17
Value	-.18 (2.27)	-2.35 (3.64)

Primary outcome: Change in Well-being

Time frame: Baseline and 2 weeks post-baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Control n = 17	Meditation n = 16
Value	3.00 (8.89)	3.75 (10.33)

Primary outcome: Change in Worry

Time frame: Baseline and 2 weeks post-baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Control n = 15	Meditation n = 17
Value	-0.13 (7.03)	-1.59 (6.05)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, an average of 2 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Meditation	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Courtney Guenther principal investigator

Winthrop University - Rock Hill, SC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Breathing meditation in people with Healthy, run by Winthrop University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mindfulness (time frame: Baseline and 2 weeks post-baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05101343.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.