NCT03048786

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

February 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2017

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

February 6, 2017

Last Update Submit

August 29, 2023

Conditions

Keywords

Peer mentoringsocial supporttext messagingsmoking cessation

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months after quit day

Secondary Outcomes (8)

  • Self-reported smoking status

    3 months after quit day

  • Duration of engagement

    Up to 8 weeks

  • Satisfaction with the program

    3 months after quit day

  • Proportion of participants who correctly self-report their message type

    3 months after quit day

  • Change in average cigarettes per day

    3 months after quit day

  • +3 more secondary outcomes

Other Outcomes (20)

  • Self-reported smoking status during the intervention

    From quit day to day 90

  • Recommends the program

    3 months after quit day

  • Helpfulness of information

    3 months after quit day

  • +17 more other outcomes

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Participants will receive automated text messages drawn from the script used by SmokefreeTXT.

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.

Behavioral: Peer Mentoring

Interventions

ControlBEHAVIORAL

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.

Control Arm
Peer MentoringBEHAVIORAL

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.

Peer Mentoring Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not a current user of nicotine replacement therapy
  • Not a current user of electronic cigarettes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Smoking CessationTobacco Use

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Justin S White, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 9, 2017

Study Start

February 6, 2017

Primary Completion

August 14, 2017

Study Completion

August 14, 2017

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations