Individually Tailored and Integrated Social Support Network for Tobacco Cessation

Smoking Cessation Clinical Trial

Official title:

Live Inspired: Individually Tailored and Integrated Social Support Network for Tobacco Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03152253
• Other study ID #: 860485-7
• Status: Completed
• Phase: N/A
• Start date: May 30, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: March 2019
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Text My Quit (TMQ)
Text messages designed to aid smoking cessation
• Peer Support
A group chat room for peer support

Other:
• Motivational Messages
Generic motivational messages not related to smoking cessation

Locations

Country	Name	City	State
United States	The Miriam Hospital- CORO building	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	Live Inspired, LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Abstinence	Self-report of no smoking for the past 7 days	6 month follow up
Secondary	Social support network use	number of messages sent to the chat room	12 weeks