| Primary | Time to First Quit Attempt | 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. | | Posted | | Mean | Standard Deviation | days | | 6 months | | | | ID | Title | Description |
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| OG000 | 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. NRT and mHealth assessment tool without feedback: NRT and mHealth assessment tool without feedback | | OG001 | 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. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0000.89± 1.04
- OG0011.48± 2.29
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The primary hypothesis was tested through a time-to-event analysis implemented using Cox proportional hazards models | Regression, Cox | | 0.02 | | Cox Proportional Hazard | 1.68 | | | 2-Sided | 95 | 1.09 | 2.60 | | | | | Other | | |
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| Secondary | Change in Self-Efficacy at the End of the 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. | | Posted | | Mean | Standard Deviation | SEQ-12 overall score (mean) | | 6 months | | | | ID | Title | Description |
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| OG000 | 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. NRT and mHealth assessment tool without feedback: NRT and mHealth assessment tool without feedback | | OG001 | 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. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games. |
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| Secondary | Point Prevalent Cessation as Measured by Carbon Monoxide Levels | 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. | | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
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| OG000 | 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. NRT and mHealth assessment tool without feedback: NRT and mHealth assessment tool without feedback | | OG001 | 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. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games. |
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| Secondary | Mean Number of Days Abstinent During the First 3 Weeks | Measure the mean number of days abstinent as self-reported by participant via the mHealth assessment. | The number of participants analyzed is higher than the number of participants who completed the study as all participants were able to self-reported the number of days abstinent at three weeks. | Posted | | Mean | Standard Deviation | days | | 3 Weeks | | | | ID | Title | Description |
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| OG000 | 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. NRT and mHealth assessment tool without feedback: NRT and mHealth assessment tool without feedback | | OG001 | 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. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games. |
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| Secondary | Number of Participants Abstinent During the First 3 Weeks | Number of participants abstinent within the 3 week period as self-reported by participant via the mHealth assessment. . | The population analyzed includes participants who eventually dropped out. | Posted | | Count of Participants | | Participants | | 3 Weeks | | | | ID | Title | Description |
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| OG000 | 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. NRT and mHealth assessment tool without feedback: NRT and mHealth assessment tool without feedback | | OG001 | 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. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games. |
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| Other Pre-specified | Number of Participants Completing Daily Challenge Quiz | 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) | The number of participants analyzed is higher than the number of participants who completed the study as all participants were able to complete daily challenge quizzes at baseline and at three weeks. | Posted | | Count of Participants | | Participants | | 3 weeks | | | | ID | Title | Description |
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| OG000 | 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. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games. |
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| Other Pre-specified | Number of Participants Completing a Call With Study Team to Establish a Smoking Abstinence Goal. | 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. | The number of participants analyzed is higher than the number of participants who completed the study as more participants were able to complete goal setting at baseline. | Posted | | Count of Participants | | Participants | | 1 week | | | | ID | Title | Description |
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| OG000 | 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. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games. |
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| Other Pre-specified | Number of Participants Use of Mobile Health Application (mHealth App) to Manage Nicotine Cravings. | 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. | The number of participants analyzed varies from number completed to reflect the number of participants still engaged at 3 weeks. | Posted | | Count of Participants | | Participants | | 3 week | | | | ID | Title | Description |
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| OG000 | 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. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games. |
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| Other Pre-specified | Number of TAB Participants Setting a Brief Abstinence Goal With the TTS (Tobacco Treatment Specialist) | 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 | | Posted | | Count of Participants | | Participants | | 2 week | | | | ID | Title | Description |
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| OG000 | 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. Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games. |
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