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Completed

NCT Number: NCT02973425

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

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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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reliant Medical Group, Worcester, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Exclusion Criteria: Those unwilling to sample nicotine lozenges or participate in the game will be excluded. All patients already on NRT will be excluded. All participants who have a FDA contraindication or cautions for nicotine lozenge use (pregnancy, breastfeeding, recent cardiovascular distress, or phenylketonuria) will be excluded. We have chosen to exclude patients with a diagnosis of depression, due to confounding factors.

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.

Treatment and study plan

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

Behavioral

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

NRT and mHealth assessment tool without feedback

Behavioral

NRT and mHealth assessment tool without feedback

Primary outcomes

  1. Time to First Quit Attempt

    Time frame: 6 months

    Time to first quit attempt is measured by participant self-report of number of days from baseline to first quit attempt within a 6 month period. At the 6-month follow-up visit, the dates of all quit attempts were assessed using the Timeline Follow-Back Method and used to calculate time to first quit attempt.

Secondary outcomes

  1. Change in Self-Efficacy at the End of the 6 Months

    Time frame: 6 months

    Self Efficacy is measured by the Self-Efficacy Questionnaire (SEQ-12).The SEQ-12 is a 12-item instrument (two six-item subscales) that measures the confidence in ability to refrain from smoking when facing internal stimuli (e.g. feeling depressed) and external stimuli (e.g. being with smokers).

    The scale varies from 1-5 [Not at all (1) Not very(2) Moderately(3) Very (4) Extremely (5)] A higher score indicates a higher level of confidence to refrain from smoking in certain social or emotional situations and a lower score indicates a lower level of confidence to refrain from smoking.

  2. Point Prevalent Cessation as Measured by Carbon Monoxide Levels

    Time frame: 6 months

    Point prevalent cessation here is measured by the number of participants with a decreased carbon monoxide level as verified by carbon monoxide levels in blood.

  3. Mean Number of Days Abstinent During the First 3 Weeks

    Time frame: 3 Weeks

    Measure the mean number of days abstinent as self-reported by participant via the mHealth assessment.

  4. Number of Participants Abstinent During the First 3 Weeks

    Time frame: 3 Weeks

    Number of participants abstinent within the 3 week period as self-reported by participant via the mHealth assessment.

    .

Other outcomes

  1. Number of Participants Completing Daily Challenge Quiz

    Time frame: 3 weeks

    Participants were asked to complete daily challenge quizzes during the first 3 weeks of participation. The challenge quizzes contained daily self-assessment text messages and motivational replies (intervention only)

  2. Number of Participants Completing a Call With Study Team to Establish a Smoking Abstinence Goal.

    Time frame: 1 week

    Participants in the Intervention group were asked to participate in a goal-setting call to establish a smoking abstinence goal (typically one to two days of abstinence from cigarettes). The outcome measures the number of participants who completed to goal-setting call.

  3. Number of Participants Use of Mobile Health Application (mHealth App) to Manage Nicotine Cravings.

    Time frame: 3 week

    TAB participants were encouraged to use mHealth apps that provide relaxation or distraction to help manage smoking cravings. The study team measured the number of participants used mHealth apps to manage nicotine cravings in a 3 week period.

  4. Number of TAB Participants Setting a Brief Abstinence Goal With the TTS (Tobacco Treatment Specialist)

    Time frame: 2 week

    At one week TAB participants were asked to whether they would like to set an abstinence goal for the following 2-week challenge. The outcome measures the number of participants in the TAB group who set a brief abstinence goal

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2016
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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