Clinical trial NCT03152253: Individually Tailored and Integrated Social Support Network for Tobacco Cessation
Official title: Live Inspired: Individually Tailored and Integrated Social Support Network for Tobacco Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Tobacco, Smoking, Text Message
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: Live Inspired, LLC
First posted: 2017-05-12
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Smoking Abstinence
timeFrame: 6 month follow up
Secondary outcomes:
measure: Social support network use
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital- CORO building
state: Rhode Island
Study officials:
affiliation: Live Inspired, LLC
name: Christopher Deutsch, BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bock BC, Rosen RK, Barnett NP, Thind H, Walaska K, Foster R, Deutsch C, Traficante R. Translating Behavioral Interventions Onto mHealth Platforms: Developing Text Message Interventions for Smoking and Alcohol. JMIR Mhealth Uhealth. 2015 Feb 24;3(1):e22. doi: 10.2196/mhealth.3779.