Take a Break (TAB): mHealth-assisted Skills Building Challenge for Unmotivated Smokers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02973425|
Recruitment Status : Completed
First Posted : November 25, 2016
Last Update Posted : November 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: Take a Break as an augmentation to NRT-sampling in Motivation Phase Behavioral: NRT and mHealth assessment tool without feedback||Not Applicable|
The Take a Break intervention is designed to increase self-efficacy and support new skills for Motivation Phase smokers. We hypothesize that, compared with the NRT-only group, the Take a Break group will have a greater number of days abstinent during the 'break' period, a greater increase in self-efficacy at the end of the 'break' period, a lower time to first quit attempt, and a higher rate of quit at 6 months. This research study will also provide valuable insight into this population of smokers and increase our understanding of which tools may be effective in helping them quit smoking Our Specific Aims are
- AIM 1: Refine the Take a Break mHealth tool and implementation program.
- AIM 2: Conduct a randomized trial of the effectiveness of Take a Break.
- AIM 3: Follow participants in the AIM 2 randomized clinical trial for 6 months to evaluate time to quit attempts, number of quit attempts, and 6-month biochemically verified point prevalent cessation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||433 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Take a Break (TAB): mHealth-assisted Skills Building Challenge for Unmotivated Smokers|
|Actual Study Start Date :||November 7, 2016|
|Actual Primary Completion Date :||July 31, 2020|
|Actual Study Completion Date :||July 31, 2020|
Active Comparator: NRT and mHealth assessment tool without feedback
For the comparison group, implementation will be balanced in all variables except the Take a Break Intervention. The investigators will balance the two groups further by having the comparison (NRT-Sampling group) complete mHealth assessments (without feedback or goal-setting) as an attention control.
Participants randomized to the comparison group will only have access to a mHealth assessment tool similar to the "Challenge Quizzes" but without feedback.
Behavioral: NRT and mHealth assessment tool without feedback
NRT and mHealth assessment tool without feedback
Experimental: Take a Break as an augmentation to NRT in Motivation
The Intervention: Take a Break as an augmentation to NRT-sampling in Motivation Phase. Take a Break is an intervention in which smokers are encouraged to engage in smoking abstinence. The main element, the "Break," is a two-week challenge where smokers report days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge Quizzes (ecological momentary assessments) collect information to guide the smokers during the Break. At baseline, all smokers will be provided NRT lozenges for sampling. At weeks 1 and 3 of the "Marathon", our Tobacco Treatment Specialist will call all smokers, assess their experiences and collect data.Participants in the intervention will receive the full tool suite.
Behavioral: Take a Break as an augmentation to NRT-sampling in Motivation Phase
NRT sampling experience & Suite of mHealth motivational tools and mini-games.
- Lower time to first quit attempt (1-survival in longitudinal analysis) Time to first quit attempt (mean survival) [ Time Frame: 6 months ]Quit attempts and cessation will be assessed at follow-up surveys at 6 months. Quit attempts will be assessed using the Timeline follow back method, which uses a calendar to reconstruct smoking behaviors
- Greater increase in self-efficacy at the end of the 3-week experience: [ Time Frame: 3 week ]Change in Self-Efficacy is defined as the difference in reported self-efficacy (SEQ-12)28 comparing baseline and follow-up at the end of the 3 week experience for intervention and NRT-only comparison patients
- Higher rate of point prevalent cessation measured at 6 months Six-month point prevalent smoking cessation [ Time Frame: 6 months ]Smoking cessation trialists have recommended assessment of smoking cessation in randomized trials of motivational interventions of point prevalence cessation. The Take a Break trial is defined as a test of treatment to motivation cessation (also termed cessation induction). As Hughes and colleagues for the Society for Research in Nicotine and Tobacco Workgroup on Measurement note, point prevalence cessation is often the best measure for motivation phase trials.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973425
|United States, Massachusetts|
|Reliant Medical Group|
|Worcester, Massachusetts, United States, 01605|
|VA Central Western Massachusetts Healthcare System|
|Worcester, Massachusetts, United States, 01605|
|University of Massachusetts Medical School|
|Worcester, Massachusetts, United States, 01655|
|United States, New York|
|Great Neck, New York, United States, 11030|
|Principal Investigator:||Rajani S Sadasivam, PhD||UMMS|