Trial Outcomes & Findings for Take a Break (TAB): mHealth-assisted Skills Building Challenge for Unmotivated Smokers (NCT NCT02973425)

NCT ID: NCT02973425

Last Updated: 2022-08-11

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 433 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2022-08-11

Participant Flow

Study participants were recruited from UMMHC, Northwell Health, VACWM. Recruitment activities started on November 2016.

Participant milestones

Measure	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	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.
Overall Study STARTED	220	213
Overall Study COMPLETED	171	160
Overall Study NOT COMPLETED	49	53

Reasons for withdrawal

Measure	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	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.
Overall Study Lost to Follow-up	49	53

Baseline Characteristics

The Row population differs from the Overall because some participants didn't report values on some demographic variables.

Baseline characteristics by cohort

Measure	NRT and mHealth Assessment Tool Without Feedback n=220 Participants 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	Take a Break as an Augmentation to NRT in Motivation n=213 Participants 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.	Total n=433 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=212 Participants • The Row population differs from the Overall because some participants didn't report values on some demographic variables.	0 Participants n=201 Participants • The Row population differs from the Overall because some participants didn't report values on some demographic variables.	0 Participants n=413 Participants • The Row population differs from the Overall because some participants didn't report values on some demographic variables.
Age, Categorical Between 18 and 65 years	169 Participants n=212 Participants • The Row population differs from the Overall because some participants didn't report values on some demographic variables.	163 Participants n=201 Participants • The Row population differs from the Overall because some participants didn't report values on some demographic variables.	332 Participants n=413 Participants • The Row population differs from the Overall because some participants didn't report values on some demographic variables.
Age, Categorical >=65 years	43 Participants n=212 Participants • The Row population differs from the Overall because some participants didn't report values on some demographic variables.	38 Participants n=201 Participants • The Row population differs from the Overall because some participants didn't report values on some demographic variables.	81 Participants n=413 Participants • The Row population differs from the Overall because some participants didn't report values on some demographic variables.
Sex: Female, Male Female	108 Participants n=220 Participants	115 Participants n=213 Participants	223 Participants n=433 Participants
Sex: Female, Male Male	112 Participants n=220 Participants	98 Participants n=213 Participants	210 Participants n=433 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=220 Participants	15 Participants n=213 Participants	43 Participants n=433 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	190 Participants n=220 Participants	197 Participants n=213 Participants	387 Participants n=433 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=220 Participants	1 Participants n=213 Participants	3 Participants n=433 Participants
Region of Enrollment United States	220 participants n=220 Participants	213 participants n=213 Participants	433 participants n=433 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	NRT and mHealth Assessment Tool Without Feedback n=171 Participants 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	Take a Break as an Augmentation to NRT in Motivation n=160 Participants 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.
Time to First Quit Attempt	0.89 days Standard Deviation 1.04	1.48 days Standard Deviation 2.29

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	NRT and mHealth Assessment Tool Without Feedback n=171 Participants 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	Take a Break as an Augmentation to NRT in Motivation n=160 Participants 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.
Change in Self-Efficacy at the End of the 6 Months	2.7 SEQ-12 overall score (mean) Standard Deviation 0.9	2.9 SEQ-12 overall score (mean) Standard Deviation 1.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	NRT and mHealth Assessment Tool Without Feedback n=171 Participants 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	Take a Break as an Augmentation to NRT in Motivation n=160 Participants 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.
Point Prevalent Cessation as Measured by Carbon Monoxide Levels	17 Participants	28 Participants

SECONDARY outcome

Timeframe: 3 Weeks

Population: 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.

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

Outcome measures

Measure	NRT and mHealth Assessment Tool Without Feedback n=209 Participants 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	Take a Break as an Augmentation to NRT in Motivation n=200 Participants 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.
Mean Number of Days Abstinent During the First 3 Weeks	0.60 days Standard Deviation 2.38	1.20 days Standard Deviation 3.02

SECONDARY outcome

Timeframe: 3 Weeks

Population: The population analyzed includes participants who eventually dropped out.

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

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Outcome measures

Measure	NRT and mHealth Assessment Tool Without Feedback n=209 Participants 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	Take a Break as an Augmentation to NRT in Motivation n=200 Participants 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.
Number of Participants Abstinent During the First 3 Weeks	29 Participants	49 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 weeks

Population: 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.

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)

Outcome measures

Measure	NRT and mHealth Assessment Tool Without Feedback n=213 Participants 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	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.
Number of Participants Completing Daily Challenge Quiz	112 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 week

Population: 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.

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.

Outcome measures

Measure	NRT and mHealth Assessment Tool Without Feedback n=213 Participants 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	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.
Number of Participants Completing a Call With Study Team to Establish a Smoking Abstinence Goal.	199 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 week

Population: The number of participants analyzed varies from number completed to reflect the number of participants still engaged at 3 weeks.

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.

Outcome measures

Measure	NRT and mHealth Assessment Tool Without Feedback n=213 Participants 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	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.
Number of Participants Use of Mobile Health Application (mHealth App) to Manage Nicotine Cravings.	159 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	NRT and mHealth Assessment Tool Without Feedback n=213 Participants 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	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.
Number of TAB Participants Setting a Brief Abstinence Goal With the TTS (Tobacco Treatment Specialist)	145 Participants	—

Adverse Events

NRT and mHealth Assessment Tool Without Feedback

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Take a Break as an Augmentation to NRT in Motivation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rajani Sadasivam

UMass Chan Medical School

Phone: 15088568923

Email: Rajani.Sadasivam@umassmed.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place