Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation
Part of paid clinical trials in Minneapolis, Minnesota.
- Sponsor
- University of Minnesota
- Study ID
- NCT07789496
- Status
- Not Yet Recruiting
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Conditions
- Cigarette Smoking
- Nicotine Dependence
- Smoking Cessation
- Tobacco Use
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Mindful Smoking and Sensor-Band Intervention — BEHAVIORALThe 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 Information — BEHAVIORALParticipants 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 Details
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.
Key Dates
- First listed
- Aug 27, 2026
- Start date
- Sep 1, 2026
- Status verified
- Aug 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Mindful Smoking and Sensor-Band InterventionParticipants 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.
- Active Comparator: Smoking Cessation Information ControlParticipants 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.
Primary Outcome Measure
Recruitment rate [ Time Frame: Baseline / recruitment period, up to 6 months ]
Central Contacts
- Fang Lei, PhD, MSN, MPH, RN612-626-7021
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Minnesota School of Nursing | Minneapolis | Minnesota | 55455 | Fang Lei, PhD, MSN, MPH, RN (PRINCIPAL_INVESTIGATOR) |
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