Mobile-based Peer Mentoring for Smoking Cessation

August 29, 2023 updated by: University of California, San Francisco

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

Completed

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Francisco, California, United States, 94118
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Active Comparator: Control Arm
Participants will receive automated text messages drawn from the script used by SmokefreeTXT.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after quit day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after quit day
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.
Up to 8 weeks
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."
3 months after quit day
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:

  1. assigned to automated messages and self-reports receiving automated messages only,
  2. assigned to automated messages and self-reports receiving at least some messages from a mentor,
  3. assigned to mentor messages and self-reports receiving at least some mentor messages, and
  4. assigned to mentor messages and self-reports receiving automated messages only.
3 months after quit day
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
3 months after quit day
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.
Throughout the 6-8 week intervention
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.
Throughout the 6-8 week intervention
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.
Throughout the 6-8 week intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From quit day to day 90
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 months after quit day
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.
3 months after quit day
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.
3 months after quit day
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.
3 months after quit day
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.
3 months after quit day
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.
3 months after quit day
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.
3 months after quit day
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.
3 months after quit day
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.
3 months after quit day
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.
3 months after quit day
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.
3 months after quit day
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.
3 months after quit day
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.
Throughout the 6-8 week intervention
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.
Throughout the 6-8 week intervention
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.
3 months after enrollment
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.
3 months after enrollment
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.
3 months after enrollment
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.
3 months after enrollment
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.
3 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Justin S White, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2017

Primary Completion (Actual)

August 14, 2017

Study Completion (Actual)

August 14, 2017

Study Registration Dates

First Submitted

February 6, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (Estimated)

February 9, 2017

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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