Take a Break (TAB): mHealth-assisted Skills Building Challenge for Unmotivated Smokers

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

433 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-07

Study Completion Date

2020-07-31

Brief Summary

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Take a Break (TAB) is a randomized trial designed to evaluate Nicotine Replacement Therapy (NRT)-sampling and a mHealth suite of apps. TAB is a time-limited self-efficacy and skills building experience for Motivation Phase smokers. TAB is designed to create a timeline within which motivation smokers will be encouraged to try a brief period of abstinence. Smokers in this Motivation Phase are relatively untapped in research available information. This project offers these smokers point-of-need technology support in the many components of the intervention..

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Detailed Description

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

NRT and mHealth assessment tool without feedback

Intervention Type BEHAVIORAL

NRT and mHealth assessment tool without feedback

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.

Group Type EXPERIMENTAL

Take a Break as an augmentation to NRT-sampling in Motivation Phase

Intervention Type BEHAVIORAL

NRT sampling experience \& Suite of mHealth motivational tools and mini-games.

Interventions

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Take a Break as an augmentation to NRT-sampling in Motivation Phase

NRT sampling experience \& Suite of mHealth motivational tools and mini-games.

Intervention Type BEHAVIORAL

NRT and mHealth assessment tool without feedback

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* For all Aims, investigators will include individuals 18 years and older who are identified as current smokers who are not preparing to quit, and are active in care within the UMMHC system, Northwell Health in Long Island, NY, Reliant Medical Group (RMG) in Worcester, MA and Central Western Massachusetts VA (VACWM) in Worcester, MA. Active in care is defined as having at least two clinical visits in the past year. If an eligible participant does not already have a smart phone, one will be provided to them, free of charge, for the duration of their participation in the study.

Exclusion Criteria

Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), and prisoners will be excluded from this study. The Food and Drug Administration (FDA) advises caution for nicotine lozenge use among women who are pregnant. Thus, women who are pregnant at the time of baseline will be excluded from the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No