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

9 de septiembre de 2026 actualizado por: University of Minnesota

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Fang Lei, PhD, MSN, MPH, RN
  • Número de teléfono: 612-626-7021
  • Correo electrónico: flei@umn.edu

Ubicaciones de estudio

    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • University of Minnesota School of Nursing
        • Contacto:
          • Fang Lei, PhD, MSN, MPH, RN
          • Número de teléfono: 612-626-7021
          • Correo electrónico: flei@umn.edu
        • Investigador principal:
          • Fang Lei, PhD, MSN, MPH, RN

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Mindful Smoking and Sensor-Band Intervention
Participants 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.
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.
Otros nombres:
  • Quit With Sense
Comparador activo: Smoking Cessation Information Control
Participants 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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Recruitment rate
Periodo de tiempo: Baseline / recruitment period, up to 6 months
Recruitment rate will be measured as the proportion of eligible participants who agree to participate in the study.
Baseline / recruitment period, up to 6 months
Time to recruit target sample
Periodo de tiempo: Up to 6 months
Time to recruit the target sample will be measured as the duration of time required to recruit the target sample size.
Up to 6 months
Intervention uptake rate
Periodo de tiempo: 8 weeks
Intervention uptake rate will be measured as the percentage of participants who complete the intervention.
8 weeks
Attrition rate
Periodo de tiempo: Up to 4 months after completion of the 8-week intervention
Attrition rate will be measured as the percentage of participants who drop out before completing the study.
Up to 4 months after completion of the 8-week intervention
Client satisfaction
Periodo de tiempo: 8 weeks

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.

8 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
8-week smoking abstinence rate
Periodo de tiempo: 8 weeks
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.
8 weeks
8-week smoking reduction
Periodo de tiempo: Baseline to 8 weeks
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.
Baseline to 8 weeks
4-month smoking abstinence rate
Periodo de tiempo: 4 months after completion of the intervention
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.
4 months after completion of the intervention
4-month smoking reduction
Periodo de tiempo: Baseline to 4 months after completion of the intervention
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.
Baseline to 4 months after completion of the intervention
Stress level
Periodo de tiempo: Baseline to 8 weeks
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.
Baseline to 8 weeks
Self-control and management level
Periodo de tiempo: Baseline to 8 weeks

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.

Baseline to 8 weeks
Mindfulness level
Periodo de tiempo: Baseline to 8 weeks
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.
Baseline to 8 weeks
Respiratory Rate Measured by Smartphone-Based Sensor-Band
Periodo de tiempo: During the 8-week intervention period
Respiratory rate will be measured in breaths per minute using the smartphone-based sensor-band among intervention group participants.
During the 8-week intervention period
Heart Rate Variability Measured by Smartphone-Based Sensor-Band
Periodo de tiempo: During the 8-week intervention period

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.

During the 8-week intervention period
Skin Temperature Measured by Smartphone-Based Sensor-Band
Periodo de tiempo: During the 8-week intervention period
Skin temperature will be measured in degrees Fahrenheit using the smartphone-based sensor-band among intervention group participants.
During the 8-week intervention period
Resting Heart Rate Measured by Smartphone-Based Sensor-Band
Periodo de tiempo: During the 8-week intervention period
Resting heart rate will be measured in beats per minute using the smartphone-based sensor-band among intervention group participants.
During the 8-week intervention period
Heart rate during craving and mindful smoking practice
Periodo de tiempo: During the 8-week intervention period
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.
During the 8-week intervention period

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Fang Lei, PhD, MSN, MPH, RN, University of Minnesota

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

10 de octubre de 2026

Finalización primaria (Estimado)

31 de diciembre de 2027

Finalización del estudio (Estimado)

31 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

3 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de agosto de 2026

Publicado por primera vez (Actual)

27 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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