Individually Tailored and Integrated Social Support Network for Tobacco Cessation

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Text My Quit (TMQ); Behavioral: Peer Support; Other: Motivational Messages

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 Type: Interventional
• Enrollment (Actual): 284
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • The Miriam Hospital- CORO building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Text Message for Smoking Cessation; 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	Behavioral: Text My Quit (TMQ); Text messages designed to aid smoking cessation; Behavioral: Peer Support; A group chat room for peer support
Placebo Comparator: Non-Interventional Text Messages; General motivational text messages sent on the same schedule at TMQ arm of the study with access to a social support chat room.	Behavioral: Peer Support; A group chat room for peer support; Other: Motivational Messages; Generic motivational messages not related to smoking cessation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Abstinence	Self-report of no smoking for the past 7 days	6 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social support network use	number of messages sent to the chat room	12 weeks

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: Live Inspired, LLC
• Investigators: Principal Investigator: Christopher Deutsch, BS, Live Inspired, LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2017
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Tobacco, Smoking, Text Message
• Other Study ID Numbers: 860485-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No