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Smoking CessationNCT07789496

Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation

A study testing Mindful Smoking and Sensor-Band Intervention and Smoking Cessation Information in people with Smoking Cessation and Cigarette Smoking, run by University of Minnesota at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This pilot randomized controlled trial will test the feasibility of a smoking cessation intervention using mindful smoking practice and a smartphone-based sensor-band among adults who regularly smoke cigarettes. Participants will be randomized to either an intervention group or a control group. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking Cessation, Cigarette Smoking, Tobacco Use
What is being tested?
Mindful Smoking and Sensor-Band Intervention and Smoking Cessation Information
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
10 Nov 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 years and older
  • Smoking at least 5 cigarettes per day on average over the past 3 months
  • Motivated to quit smoking, indicated by answering "yes" to being interested in quitting smoking or making a quit attempt in the next 30 days
  • Has a functioning Android or iOS smartphone
  • Has a telephone number available for contact

Who cannot join

  • Recent change in the dosage or type of new medications, if taking medications, or unstable medical situation in the past 3 months
  • Active substance dependence other than nicotine
  • Use of other non-cigarette tobacco products, including e-cigarettes, more than 15 days per month
  • Another household member enrolled in the study
  • Participation in a smoking cessation program in the past 30 days

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fang Lei, PhD, MSN, MPH, RN contact

612-626-7021

flei@umn.edu

United States1 site
  • University of Minnesota School of Nursing

    Minneapolis, Minnesota, 55455

    Fang Lei, PhD, MSN, MPH, RN, 612-626-7021, flei@umn.edu

    Fang Lei, PhD, MSN, MPH, RN

Other trials in United States

About this study

Official title: Quit With Sense: A Pilot Smoking Cessation Intervention Study Using Mindful Smoking and Smartphone-Based Sensor-Band

This pilot randomized controlled trial will test the feasibility of a smoking cessation intervention using mindful smoking practice and a smartphone-based sensor-band among adults who regularly smoke cigarettes.

Participants will be randomized to either an intervention group or a control group. Participants in the intervention group will receive a one-on-one mindful smoking guidance session, instructions for using a smartphone-based sensor-band, a mindfulness practice video, and smoking cessation information. Participants in the control group will receive smoking cessation information. The intervention period will last 8 weeks, with assessments at baseline, 8 weeks, and 4 months after completion of the intervention.

The study will evaluate feasibility, preliminary smoking cessation outcomes, and physiologic parameters including heart rate variation, skin temperature, resting heart rate, respiratory rate, and real-time heart rate during craving and mindful smoking practice.

Read the detailed description

Cigarette smoking is a leading preventable cause of morbidity and mortality and contributes to cancer, lung disease, health care costs, and reduced quality of life. Although many adults who smoke cigarettes attempt to quit, long-term cessation rates remain low. Mindfulness-based strategies may help people who smoke manage cravings by increasing awareness of present-moment thoughts, emotions, and physical sensations without automatically reacting by smoking.

This pilot randomized controlled trial will evaluate a smoking cessation intervention that combines mindful smoking practice with use of a smartphone-based sensor-band. The study will enroll 30 adults who regularly smoke cigarettes and are motivated to quit smoking or make a quit attempt. Participants will be randomly assigned to an intervention group or a control group, with approximately 15 participants in each group.

Participants in the intervention group will receive a one-hour, one-on-one, in-person mindful smoking guidance session from a certified mindfulness instructor. The session will teach participants to manage cravings mindfully using the RAIN method: Recognize, Accept, Investigate, and Note. Participants will also receive a mindfulness practice video for home practice and in-person instruction from a research assistant on use of the smartphone-based sensor-band. During the 8-week self-management and intervention period, participants in the intervention group will be instructed to practice mindful smoking when they feel a craving to smoke. They will be asked to record their craving level, duration of mindful smoking practice, feelings after mindful smoking, heart rate at the time of craving, heart rate at the end of mindful smoking practice, and daily cigarette smoking activities.

Participants in the control group will receive smoking cessation information published by the American Lung Association, including printed smoking cessation materials. Control group participants will be asked to record their daily cigarette smoking activities.

Data will be collected at baseline, 8 weeks after the intervention begins, and 4 months after the intervention is completed. Feasibility will be assessed by recruitment rate, time to recruit the target sample, intervention uptake rate, attrition rate, and participant satisfaction. Preliminary effectiveness will be assessed by 8-week and 4-month smoking abstinence rates and smoking reduction. Smoking abstinence will be confirmed using exhaled carbon monoxide measurement. The study will also assess stress level, self-control and management level, mindfulness level, heart rate variation, skin temperature, resting heart rate, respiratory rate, and real-time heart rate during craving and mindful smoking practice.

Being tested
Mindful Smoking and Sensor-Band Intervention, Smoking Cessation Information
Keywords
Mindful smoking, Smoking cessation, Mindfulness, Smartphone-based sensor-band, WHOOP sensor-band, Tobacco cessation
Medical subject headings
Smoking Cessation, Cigarette Smoking, Tobacco Use, Tobacco Use Disorder, Tobacco Use Cessation

What participants receive

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

  • Mindful Smoking and Sensor-Band InterventionBehavioural

    Also called Quit With Sense

    The intervention includes a one-hour, one-on-one mindful smoking guidance session using the RAIN method, which includes Recognize, Accept, Investigate, and Note. Participants will also receive a mindfulness practice video and instructions for using a smartphone-based sensor-band. During the 8-week intervention period, participants will practice mindful smoking when they feel a craving to smoke and will record craving level, duration of practice, feelings after practice, heart rate at craving time, heart rate at the end of mindful smoking practice, and daily smoking activities.

  • Smoking Cessation InformationBehavioural

    Participants will receive smoking cessation information published by the American Lung Association, including printed materials such as The Smoking Health Effects brochure and Top Tips for Quitting Smoking.

Study groups in NCT07789496
Study groupRoleWhat they receive
Mindful Smoking and Sensor-Band InterventionExperimentalParticipants in this arm will receive a one-hour, one-on-one mindful smoking guidance session from a certified mindfulness instructor, instruction on use of the smartphone-based sensor-band, a mindfulness practice video for home practice, and smoking cessation information. During the 8-week intervention period, participants will be instructed to practice mindful smoking when they feel a craving to smoke and to record craving level, duration of mindful smoking practice, feelings after practice, heart rate at craving time, heart rate at the end of mindful smoking practice, and daily cigarette smoking activities.
Receives: Behavioral: Mindful Smoking and Sensor-Band Intervention
Smoking Cessation Information ControlActive comparatorParticipants in this arm will receive smoking cessation information published by the American Lung Association, including printed smoking cessation materials. Participants will be asked to record their daily cigarette smoking activities in a paper notebook.
Receives: Behavioral: Smoking Cessation Information

What is being measured

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

  1. Recruitment rate

    Recruitment rate will be measured as the proportion of eligible participants who agree to participate in the study.

    Measured: Baseline / recruitment period, up to 6 months

  2. Time to recruit target sample

    Time to recruit the target sample will be measured as the duration of time required to recruit the target sample size.

    Measured: Up to 6 months

  3. Intervention uptake rate

    Intervention uptake rate will be measured as the percentage of participants who complete the intervention.

    Measured: 8 weeks

  4. Attrition rate

    Attrition rate will be measured as the percentage of participants who drop out before completing the study.

    Measured: Up to 4 months after completion of the 8-week intervention

  5. Client satisfaction

    Client satisfaction will be assessed using the Satisfaction Feedback Questionnaire, adapted from the Client Satisfaction Questionnaire.

    It has 4 questions with ordinal level options. The value of the scare measurement ranges from 0 to 12. Higher score means a higher satisfaction level.

    Measured: 8 weeks

Secondary outcomes (12)
  1. 8-week smoking abstinence rate

    Smoking abstinence at 8 weeks will be measured as the percentage of participants who quit smoking at the 8-week time point. Abstinence will be confirmed by exhaled carbon monoxide measurement level of less than 8 ppm.

    Measured: 8 weeks

  2. 8-week smoking reduction

    Smoking reduction at 8 weeks will be measured as the reduction in the mean number of cigarettes smoked per day from baseline to the 8-week time point.

    Measured: Baseline to 8 weeks

  3. 4-month smoking abstinence rate

    Smoking abstinence at 4 months after intervention completion will be measured as the percentage of participants who quit smoking at the 4-month follow-up time point. Abstinence will be confirmed by exhaled carbon monoxide measurement level of less than 8 ppm.

    Measured: 4 months after completion of the intervention

  4. 4-month smoking reduction

    Smoking reduction at 4 months after intervention completion will be measured as the reduction in the mean number of cigarettes smoked per day from baseline to the 4-month follow-up time point.

    Measured: Baseline to 4 months after completion of the intervention

  5. Stress level

    Stress level will be assessed using the Perceived Stress Scale. It has 10 questions with ordinal level options. The value of the scare measurement ranges from 0 to 40. Higher score means a higher stress level.

    Measured: Baseline to 8 weeks

  6. Self-control and management level

    Self-control and management level will be assessed using the Self-control and Management Scale.

    It has 16 questions with ordinal level options. The value of the scare measurement ranges from 0 to 80. Higher score means a higher self-control and management level.

    Measured: Baseline to 8 weeks

  7. Mindfulness level

    Mindfulness level will be assessed using the Mindful Attention Awareness Scale. It has 15 questions with ordinal level options. The value of the scare measurement ranges from 0 to 75. Higher score means a higher mindful attention awareness level.

    Measured: Baseline to 8 weeks

  8. Respiratory Rate Measured by Smartphone-Based Sensor-Band

    Respiratory rate will be measured in breaths per minute using the smartphone-based sensor-band among intervention group participants.

    Measured: During the 8-week intervention period

  9. Heart Rate Variability Measured by Smartphone-Based Sensor-Band

    Physiologic parameters including respiratory rate, heart rate variation, skin temperature, and resting heart rate will be collected using the smartphone-based sensor-band among intervention group participants.

    Physiologic parameters including respiratory rate measured by breaths per minute, heart rate variation measured by milliseconds, skin temperature measured by Farehent degree, and resting heart rate measured by heart beats per minute, will be collected using the smartphone-based sensor-band among intervention group participants.

    Measured: During the 8-week intervention period

  10. Skin Temperature Measured by Smartphone-Based Sensor-Band

    Skin temperature will be measured in degrees Fahrenheit using the smartphone-based sensor-band among intervention group participants.

    Measured: During the 8-week intervention period

  11. Resting Heart Rate Measured by Smartphone-Based Sensor-Band

    Resting heart rate will be measured in beats per minute using the smartphone-based sensor-band among intervention group participants.

    Measured: During the 8-week intervention period

  12. Heart rate during craving and mindful smoking practice

    Real-time heart rate will be measured at the time of cigarette craving and at the end of mindful smoking practice among intervention group participants.

    Measured: During the 8-week intervention period

Timeline

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

  1. First posted27 Aug 2026
  2. Study start10 Nov 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to either the mindful smoking and smartphone-based sensor-band intervention group or the smoking cessation information control group. Participants in the intervention group will receive mindful smoking guidance, sensor-band instructions, a mindfulness practice video, and smoking cessation information. Participants in the control group will receive smoking cessation information.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07789496
Sponsor's protocol ID
SON-2024-32759
Other IDs
STUDY00022693
Status last verified
Oct 2026
First submitted
3 Aug 2026
Last updated
13 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Mindful Smoking and Sensor-Band Intervention and Smoking Cessation Information in people with Smoking Cessation and Cigarette Smoking, run by University of Minnesota 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Oct 2026. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Fang Lei, PhD, MSN, MPH, RN (612-626-7021, flei@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: Baseline / recruitment period, up to 6 months). 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?
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 13 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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