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Completed

NCT Number: NCT03048786

Mobile-based Peer Mentoring for Smoking Cessation

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94118, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Behavioral

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.

Peer Mentoring

Behavioral

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.

Primary outcomes

  1. Saliva test for cotinine

    Time frame: 3 months after quit day

    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.

Secondary outcomes

  1. Self-reported smoking status

    Time frame: 3 months after quit day

    Participants will self-report 7-day point prevalence of abstinence in the follow-up survey, measured 3 months after the quit day.

  2. Duration of engagement

    Time frame: Up to 8 weeks

    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.

  3. Satisfaction with the program

    Time frame: 3 months after quit day

    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."

  4. Proportion of participants who correctly self-report their message type

    Time frame: 3 months after quit day

    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:

    • assigned to automated messages and self-reports receiving automated messages only,
    • assigned to automated messages and self-reports receiving at least some messages from a mentor,
    • assigned to mentor messages and self-reports receiving at least some mentor messages, and
    • assigned to mentor messages and self-reports receiving automated messages only.

  5. Change in average cigarettes per day

    Time frame: 3 months after quit day

    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

  6. Number of participant messages sent

    Time frame: Throughout the 6-8 week intervention

    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.

  7. Proportion who unsubscribe

    Time frame: Throughout the 6-8 week intervention

    This measure of engagement is the proportion of participants who unsubscribe from the text-messaging intervention prior to the end of the intervention period.

  8. Accuracy of beliefs about personal content

    Time frame: Throughout the 6-8 week intervention

    This is the difference between the percentage of messages reported to be from a mentor (as opposed to being automated) and the actual percentage.

Other outcomes

  1. Self-reported smoking status during the intervention

    Time frame: From quit day to day 90

    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.

  2. Recommends the program

    Time frame: 3 months after quit day

    This is a 5-point Likert scale response to "I would recommend the iQuit Project to a friend," assessed in the follow-up survey.

  3. Helpfulness of information

    Time frame: 3 months after quit day

    This is a 5-point Likert scale response to "Text messages contained helpful information on quitting," assessed in the follow-up survey.

  4. Helpfulness in trying to quit

    Time frame: 3 months after quit day

    This is a 5-point Likert scale response to "Text messages helped me try to quit smoking," assessed in the follow-up survey.

  5. Timeliness of messages

    Time frame: 3 months after quit day

    This is a 5-point Likert scale response to "Text messages arrived at the right time," assessed in the follow-up survey.

  6. Personalized content of messages

    Time frame: 3 months after quit day

    This is a 5-point Likert scale response to "Text messages were created for me personally," assessed in the follow-up survey.

  7. Frequency of messages too low

    Time frame: 3 months after quit day

    This is a 5-point Likert scale response to "Text messages should have been sent more frequently," assessed in the follow-up survey.

  8. Frequency of messages too high

    Time frame: 3 months after quit day

    This is a 5-point Likert scale response to "Text messages should have been sent less frequently," assessed in the follow-up survey.

  9. Tailoring of messages

    Time frame: 3 months after quit day

    This is a 5-point Likert scale response to "Text messages applied to me specifically," assessed in the follow-up survey.

  10. Messages were caring

    Time frame: 3 months after quit day

    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.

  11. Messages gave feeling of worth

    Time frame: 3 months after quit day

    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.

  12. Messages gave feeling of competence

    Time frame: 3 months after quit day

    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.

  13. Messages gave feeling of confidence

    Time frame: 3 months after quit day

    This is a 5-point Likert scale response to "Text messages gave me confidence that I can quit," assessed in the follow-up survey.

  14. Days to unsubscribe

    Time frame: Throughout the 6-8 week intervention

    This is the number of days since enrollment that it took the participant to unsubscribe.

  15. Proportion of replies that provide informational vs. emotional support

    Time frame: Throughout the 6-8 week intervention

    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.

  16. Percentage of personalized messages

    Time frame: 3 months after enrollment

    This is the percentage of messages that the participant believes came from a mentor, as opposed to the automated script.

  17. Preference for personalized messages

    Time frame: 3 months after enrollment

    This is the percentage of participants who prefer personal messages from mentors, compared to automated messages.

  18. Integration of messages

    Time frame: 3 months after enrollment

    This is a 5-point Likert scale response to "The automated and personal messages worked well together," assessed in the follow-up survey.

  19. Satisfaction with mentor

    Time frame: 3 months after enrollment

    This is a 5-point Likert scale response to "I am satisfied with my mentor," assessed in the follow-up survey.

  20. Knowledge of mentor

    Time frame: 3 months after enrollment

    This is a 5-point Likert scale response to "I think my mentor was knowledgable," assessed in the follow-up survey.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • American Cancer Society, Inc.
  • George Washington University
  • London School of Economics and Political Science

Registry information

Official study title

Mobile-based Peer Mentoring for Smoking Cessation: A Pilot Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 9, 2017
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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