Clinical trial NCT03048786: Mobile-based Peer Mentoring for Smoking Cessation
Official title: Mobile-based Peer Mentoring for Smoking Cessation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Tobacco Use
Keywords: Peer mentoring
social support
text messaging
smoking cessation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: George Washington University
name: London School of Economics and Political Science
First posted: 2017-02-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Saliva test for cotinine
timeFrame: 3 months after quit day
Secondary outcomes:
measure: Self-reported smoking status
timeFrame: 3 months after quit day
measure: Duration of engagement
timeFrame: Up to 8 weeks
measure: Satisfaction with the program
timeFrame: 3 months after quit day
measure: Proportion of participants who correctly self-report their message type
timeFrame: 3 months after quit day
measure: Change in average cigarettes per day
timeFrame: 3 months after quit day
measure: Number of participant messages sent
timeFrame: Throughout the 6-8 week intervention
measure: Proportion who unsubscribe
timeFrame: Throughout the 6-8 week intervention
measure: Accuracy of beliefs about personal content
timeFrame: Throughout the 6-8 week intervention
Other outcomes:
measure: Self-reported smoking status during the intervention
timeFrame: From quit day to day 90
measure: Recommends the program
timeFrame: 3 months after quit day
measure: Helpfulness of information
timeFrame: 3 months after quit day
measure: Helpfulness in trying to quit
timeFrame: 3 months after quit day
measure: Timeliness of messages
timeFrame: 3 months after quit day
measure: Personalized content of messages
timeFrame: 3 months after quit day
measure: Frequency of messages too low
timeFrame: 3 months after quit day
measure: Frequency of messages too high
timeFrame: 3 months after quit day
measure: Tailoring of messages
timeFrame: 3 months after quit day
measure: Messages were caring
timeFrame: 3 months after quit day
measure: Messages gave feeling of worth
timeFrame: 3 months after quit day
measure: Messages gave feeling of competence
timeFrame: 3 months after quit day
measure: Messages gave feeling of confidence
timeFrame: 3 months after quit day
measure: Days to unsubscribe
timeFrame: Throughout the 6-8 week intervention
measure: Proportion of replies that provide informational vs. emotional support
timeFrame: Throughout the 6-8 week intervention
measure: Percentage of personalized messages
timeFrame: 3 months after enrollment
measure: Preference for personalized messages
timeFrame: 3 months after enrollment
measure: Integration of messages
timeFrame: 3 months after enrollment
measure: Satisfaction with mentor
timeFrame: 3 months after enrollment
measure: Knowledge of mentor
timeFrame: 3 months after enrollment
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Justin S White, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.