Smoking CessationNCT03048786
Mobile-based Peer Mentoring for Smoking Cessation
A study testing Peer Mentoring in people with Smoking Cessation and Tobacco Use, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Tobacco Use
- What is being tested?
- Peer Mentoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2017to 14 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not a current user of nicotine replacement therapy
- Not a current user of electronic cigarettes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94118
About this study
Official title: 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.
- Conditions
- Smoking Cessation, Tobacco Use
- Being tested
- Control, Peer Mentoring
- Keywords
- Peer mentoring, social support, text messaging, smoking cessation
- Medical subject headings
- Smoking Cessation, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
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 MentoringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Participants will receive automated text messages drawn from the script used by SmokefreeTXT. Receives: Behavioral: Control |
| Peer Mentoring Arm | Experimental | Participants will receive a modified version of the automated text messages sent to the control arm plus random assignment to a peer mentor. Receives: Behavioral: Peer Mentoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva test for cotinine
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.
Measured: 3 months after quit day
Secondary outcomes (8)
Self-reported smoking status
Participants will self-report 7-day point prevalence of abstinence in the follow-up survey, measured 3 months after the quit day.
Measured: 3 months after quit day
Duration of engagement
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.
Measured: Up to 8 weeks
Satisfaction with the program
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."
Measured: 3 months after quit day
Proportion of participants who correctly self-report their message type
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.
Measured: 3 months after quit day
Change in average cigarettes per 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
Measured: 3 months after quit day
Number of participant messages sent
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.
Measured: Throughout the 6-8 week intervention
Proportion who unsubscribe
This measure of engagement is the proportion of participants who unsubscribe from the text-messaging intervention prior to the end of the intervention period.
Measured: Throughout the 6-8 week intervention
Accuracy of beliefs about personal content
This is the difference between the percentage of messages reported to be from a mentor (as opposed to being automated) and the actual percentage.
Measured: Throughout the 6-8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start6 Feb 2017
- Primary completion14 Aug 2017
- Study completion14 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., George Washington University, London School of Economics and Political Science
- Responsible party
- Sponsor
- Investigators
- Justin S White, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048786
- Sponsor's protocol ID
- 16-18577
- Status last verified
- Aug 2023
- First submitted
- 6 Feb 2017
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
White JS, Toussaert S, Thrul J, Bontemps-Jones J, Abroms L, Westmaas JL. Peer Mentoring and Automated Text Messages for Smoking Cessation: A Randomized Pilot Trial. Nicotine Tob Res. 2020 Mar 16;22(3):371-380. doi: 10.1093/ntr/ntz047.
PubMed 30892616
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile-based Peer Mentoring for Smoking Cessation: A Pilot Study
- ClinicalTrials.gov ID
- NCT03048786
- Acronym / sponsor ID
- 16-18577
- Conditions
- Smoking Cessation, Tobacco Use
- Keywords
- Peer mentoring, social support, text messaging, smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., George Washington University, London School of Economics and Political Science
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- 14 Aug 2017 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Behavioral: ControlParticipants will receive automated text messages drawn from the script used by SmokefreeTXT. |
| Peer Mentoring Arm | Experimental | Behavioral: Peer MentoringParticipants will receive a modified version of the automated text messages sent to the control arm plus random assignment to a peer mentor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Not a current user of nicotine replacement therapy
- Not a current user of electronic cigarettes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlParticipants 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. | Behavioural | Control Arm |
| Peer MentoringParticipants 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. | Behavioural | Peer Mentoring Arm |
Primary outcome
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.
8 secondary outcomes
Self-reported smoking status
Time frame: 3 months after quit day
Duration of engagement
Time frame: Up to 8 weeks
Satisfaction with the program
Time frame: 3 months after quit day
Proportion of participants who correctly self-report their message type
Time frame: 3 months after quit day
Change in average cigarettes per day
Time frame: 3 months after quit day
Number of participant messages sent
Time frame: Throughout the 6-8 week intervention
Proportion who unsubscribe
Time frame: Throughout the 6-8 week intervention
Accuracy of beliefs about personal content
Time frame: Throughout the 6-8 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Results publication: PubMed 30892616White JS, Toussaert S, Thrul J, Bontemps-Jones J, Abroms L, Westmaas JL. Peer Mentoring and Automated Text Messages for Smoking Cessation: A Randomized Pilot Trial. Nicotine Tob Res. 2020 Mar 16;22(3):371-380. doi: 10.1093/ntr/ntz047.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
Not yet recruiting
Contingency Management to Promote Smoking Cessation Study
Smoking Cessation
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
Not yet recruiting
Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program
Focus of the Study is Smoking Cessation and Prevention, Smoking Prevention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin S White, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Mentoring in people with Smoking Cessation and Tobacco Use, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saliva test for cotinine (time frame: 3 months after quit day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03048786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.