- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03048786
Mobile-based Peer Mentoring for Smoking Cessation
Mobile-based Peer Mentoring for Smoking Cessation: A Pilot Study
Despite the availability of a variety of effective treatments for smoking cessation, uptake of treatments is low. The increasing use of smartphone technology presents an exceptional opportunity to expand access to low-cost smoking cessation services. In this pilot study, the investigators will use a text-messaging platform to test peer mentoring for smoking cessation, delivered by former smokers. While peer mentoring is a common approach to health behavior change, it has rarely been used to maximum effect by smoking cessation programs. The text-messaging platform serves as the basis for a randomized controlled trial to test the effectiveness of peer mentoring for smoking cessation.
This pilot will include approximately 200 U.S. adult smokers who will be randomly assigned to a peer mentor or not. Participants in the control group will receive automated text messages used in SmokefreeTXT, a nationwide text-messaging service sponsored by the National Cancer Institute (NCI) in which users receive one to five automated messages per day for up to eight weeks. Smokers in the intervention group will receive a modified version of the same automated messages from SmokefreeTXT, but with additional personalized messages from an assigned peer mentor. Mentors will provide responses to specific questions or comments a smoker may have after receiving the automated messages.
The intervention will last 8 weeks. The study includes primary outcomes to measure the acceptability, engagement, user experience, and early efficacy of the intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94118
- University of California, San Francisco
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least 18 years old
- Current resident of the U.S.
- Smoked 100 or more cigarettes in lifetime
- Current cigarette smoker
- Access to a device that can take pictures to be uploaded to a website
- Willing to complete a salivary cotinine test
Exclusion Criteria:
- Not a current user of nicotine replacement therapy
- Not a current user of electronic cigarettes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Control Arm
Participants will receive automated text messages drawn from the script used by SmokefreeTXT.
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Participants will receive automated text messages used by SmokefreeTXT.
The messages are designed to provide encouragement, support, and information about quitting smoking.
Participants will receive 1-5 automated messages per day for 6-8 weeks depending on choice of quit date.
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Experimental: Peer Mentoring Arm
Participants will receive a modified version of the automated text messages sent to the control arm plus random assignment to a peer mentor.
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Participants will receive a modified version of the automated text messages sent to the control arm plus random assignment to a peer mentor.
The modified messages include automated "conversation starters," designed to stimulate conversation with the peer mentor.
The peer mentor will then send personalized, tailored responses.
The peer mentor is a former smoker who has completed a training program developed by the investigator team.
Participants will receive 1-5 automated messages per day for 6-8 weeks depending on choice of quit date.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Saliva test for cotinine
Time Frame: 3 months after quit day
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The primary measure of early efficacy is the 7-day point prevalence of abstinence measured 3 months after the quit day, using a saliva cotinine test.
The saliva test results will be recorded through a series of photographs and shared with the study team via email or online upload.
Participants who self-report having smoked in the last 7 days, as part of the follow-up survey, will be considered to be continuing smokers.
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3 months after quit day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self-reported smoking status
Time Frame: 3 months after quit day
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Participants will self-report 7-day point prevalence of abstinence in the follow-up survey, measured 3 months after the quit day.
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3 months after quit day
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Duration of engagement
Time Frame: Up to 8 weeks
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The primary measure of participant engagement is the number of days from enrollment since the participant last replied to a message asking about the person's status (e.g., mood and cravings).
The status messages are common to the scripts sent to participants in the control and peer mentoring arms.
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Up to 8 weeks
|
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Satisfaction with the program
Time Frame: 3 months after quit day
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The primary measure of acceptability of the intervention is the self-reported rating of participants to the statement, "I liked participating in the iQuit Project."
Responses will be on a 5-point Likert scale from "completely disagree" to "completely agree."
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3 months after quit day
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Proportion of participants who correctly self-report their message type
Time Frame: 3 months after quit day
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The primary measure of user experience in the intervention is whether participants correctly identify the type of messages they received: automated or personal from a mentor. The measure has four categories:
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3 months after quit day
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Change in average cigarettes per day
Time Frame: 3 months after quit day
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This measures the difference in self-reported average number of cigarettes smoked per day from the baseline survey to the follow-up survey 3 months after quit day
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3 months after quit day
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Number of participant messages sent
Time Frame: Throughout the 6-8 week intervention
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This measure of engagement is the number of resp days from enrollment since the participant last replied to a message asking about the person's status (e.g., mood and cravings).
The status messages are common to the scripts sent to participants in the control and peer mentoring arms.
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Throughout the 6-8 week intervention
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Proportion who unsubscribe
Time Frame: Throughout the 6-8 week intervention
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This measure of engagement is the proportion of participants who unsubscribe from the text-messaging intervention prior to the end of the intervention period.
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Throughout the 6-8 week intervention
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Accuracy of beliefs about personal content
Time Frame: Throughout the 6-8 week intervention
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This is the difference between the percentage of messages reported to be from a mentor (as opposed to being automated) and the actual percentage.
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Throughout the 6-8 week intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported smoking status during the intervention
Time Frame: From quit day to day 90
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This is self-reported 7-day point prevalence based on text message replies to a status message.
The status messages were sent at days 7, 14, 21, 28, 35, 42, 60, and 90, relative to the person's quit date.
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From quit day to day 90
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Recommends the program
Time Frame: 3 months after quit day
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This is a 5-point Likert scale response to "I would recommend the iQuit Project to a friend," assessed in the follow-up survey.
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3 months after quit day
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Helpfulness of information
Time Frame: 3 months after quit day
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This is a 5-point Likert scale response to "Text messages contained helpful information on quitting," assessed in the follow-up survey.
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3 months after quit day
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Helpfulness in trying to quit
Time Frame: 3 months after quit day
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This is a 5-point Likert scale response to "Text messages helped me try to quit smoking," assessed in the follow-up survey.
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3 months after quit day
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Timeliness of messages
Time Frame: 3 months after quit day
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This is a 5-point Likert scale response to "Text messages arrived at the right time," assessed in the follow-up survey.
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3 months after quit day
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Personalized content of messages
Time Frame: 3 months after quit day
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This is a 5-point Likert scale response to "Text messages were created for me personally," assessed in the follow-up survey.
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3 months after quit day
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Frequency of messages too low
Time Frame: 3 months after quit day
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This is a 5-point Likert scale response to "Text messages should have been sent more frequently," assessed in the follow-up survey.
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3 months after quit day
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Frequency of messages too high
Time Frame: 3 months after quit day
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This is a 5-point Likert scale response to "Text messages should have been sent less frequently," assessed in the follow-up survey.
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3 months after quit day
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Tailoring of messages
Time Frame: 3 months after quit day
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This is a 5-point Likert scale response to "Text messages applied to me specifically," assessed in the follow-up survey.
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3 months after quit day
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Messages were caring
Time Frame: 3 months after quit day
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This is a 5-point Likert scale response to "Text messages made me feel someone cared if I quit," assessed in the follow-up survey.
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3 months after quit day
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Messages gave feeling of worth
Time Frame: 3 months after quit day
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This is a 5-point Likert scale response to "Text messages made me think that it was worthwhile for me to quit," assessed in the follow-up survey.
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3 months after quit day
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Messages gave feeling of competence
Time Frame: 3 months after quit day
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This is a 5-point Likert scale response to "Text messages made me feel that I knew the right steps to take to quit," assessed in the follow-up survey.
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3 months after quit day
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Messages gave feeling of confidence
Time Frame: 3 months after quit day
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This is a 5-point Likert scale response to "Text messages gave me confidence that I can quit," assessed in the follow-up survey.
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3 months after quit day
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Days to unsubscribe
Time Frame: Throughout the 6-8 week intervention
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This is the number of days since enrollment that it took the participant to unsubscribe.
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Throughout the 6-8 week intervention
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Proportion of replies that provide informational vs. emotional support
Time Frame: Throughout the 6-8 week intervention
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This is the proportion of a participant's replies that are in response to a message coded with information support, as opposed to emotional support.
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Throughout the 6-8 week intervention
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Percentage of personalized messages
Time Frame: 3 months after enrollment
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This is the percentage of messages that the participant believes came from a mentor, as opposed to the automated script.
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3 months after enrollment
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Preference for personalized messages
Time Frame: 3 months after enrollment
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This is the percentage of participants who prefer personal messages from mentors, compared to automated messages.
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3 months after enrollment
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Integration of messages
Time Frame: 3 months after enrollment
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This is a 5-point Likert scale response to "The automated and personal messages worked well together," assessed in the follow-up survey.
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3 months after enrollment
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Satisfaction with mentor
Time Frame: 3 months after enrollment
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This is a 5-point Likert scale response to "I am satisfied with my mentor," assessed in the follow-up survey.
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3 months after enrollment
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Knowledge of mentor
Time Frame: 3 months after enrollment
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This is a 5-point Likert scale response to "I think my mentor was knowledgable," assessed in the follow-up survey.
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3 months after enrollment
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Justin S White, PhD, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 16-18577
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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