Individually Tailored and Integrated Social Support Network for Tobacco Cessation

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: Text My Quit (TMQ); Behavioral: Peer Support; Other: Motivational Messages

• Registration Number: NCT03152253
• Lead Sponsor: The Miriam Hospital

Brief Summary

This study will continue development of a quit smoking program delivered through text messaging. Upon completion of programming we will enroll 280 participants and randomize them to a control condition or the intervention condition. Assessments will occur at enrollment, and both 3 and 6 month follow ups.

Detailed Description

This study builds on pilot work in which Live Inspired LLC and research partners developed T2Q (formerly "Text-2-Quit") a smoking cessation intervention delivered through text messaging. T2Q is a unique program with a number of features that provide superior support and service compared to existing text message quit smoking products. T2Q is 100% accessible through text messaging provides medication support for quitting smoking, an integrated social support network and live counseling. This phase II project will add functionality to accommodate use of multiple forms of quit smoking medications, and then conduct a rigorous test of the efficacy of T2Q among 280 adult smokers and examine smoking outcomes compared to controls at 3 and 6 months follow up. The study will also examine changes in smoking-related attitudes and behaviors among T2Q users to identify strengths and any potential weaknesses that may affect T2Q's impact on smoking outcomes. Analyses will examine the quality of social interactions within the T2Q integrated social support network and their role in promoting smoking abstinence. We will also conduct interviews with study participants in the T2Q arm to enable understanding of the user's experience with T2Q. Results of this trial will demonstrate the efficacy of T2Q - providing important credibility needed for successful commercialization. This research will also provide important data for possible enhancements to improve consumer appeal prior to commercialization.

This proposal finalizes development and testing of a unique, highly scalable intervention that can reach a U.S. market comprised of over 34 million adult smokers who use text messaging, and provide them with effective, evidence-based treatment. Text messaging enjoys near-market saturation and is a widely preferred method of communication with deep penetration across diverse groups. Wide availability of an attractive and effective smoking cessation program such as T2Q, may exert a powerful, sustained impact on public health

Study Timeline

• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-12
• Study Start: 2017-05-30
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 284

Inclusion Criteria

• age >18
• current daily cigarette smoker
• use of text messaging at least once per week
• interested in quitting smoking within the next 30 days
• has access to a physician or healthcare provider
• no current drug/alcohol abuse.

Exclusion Criteria

• Non-English Speaking
• Currently using quit-smoking medications or therapies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Text Message for Smoking Cessation	Text My Quit (TMQ)	smoking cessation promotion messages and medication reminders sent via text messages for up to 30 days before quit day and 8 weeks following quit day, along with access to a social support chat room
Non-Interventional Text Messages	Motivational Messages	General motivational text messages sent on the same schedule at TMQ arm of the study with access to a social support chat room.
Non-Interventional Text Messages	Peer Support	General motivational text messages sent on the same schedule at TMQ arm of the study with access to a social support chat room.
Text Message for Smoking Cessation	Peer Support	smoking cessation promotion messages and medication reminders sent via text messages for up to 30 days before quit day and 8 weeks following quit day, along with access to a social support chat room

Primary Outcome Measures

Name	Time	Method
Smoking Abstinence	6 month follow up	Self-report of no smoking for the past 7 days

Secondary Outcome Measures

Name	Time	Method
Social support network use	12 weeks	number of messages sent to the chat room

Trial Locations

Locations (1)

The Miriam Hospital- CORO building; 🇺🇸 Providence, Rhode Island, United States