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..

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: NRT and mHealth assessment tool without feedback; Behavioral: Take a Break as an augmentation to NRT-sampling in Motivation Phase

Detailed Description

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
• Enrollment (Actual): 433
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
    • Worcester, Massachusetts, United States, 01605
      • Reliant Medical Group
    • Worcester, Massachusetts, United States, 01605
      • VA Central Western Massachusetts Healthcare System
  • New York
    • Great Neck, New York, United States, 11030
      • Northwell Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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.	6 months
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.	3 Weeks
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. .	3 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 weeks
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.	1 week
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.	3 week
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	2 week

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Rajani S Sadasivam, PhD, UMMS

Publications and helpful links

General Publications

• Houston TK, Chen J, Amante DJ, Blok AC, Nagawa CS, Wijesundara JG, Kamberi A, Allison JJ, Person SD, Flahive J, Morley J, Conigliaro J, Mattocks KM, Garber L, Sadasivam RS. Effect of Technology-Assisted Brief Abstinence Game on Long-term Smoking Cessation in Individuals Not Yet Ready to Quit: A Randomized Clinical Trial. JAMA Intern Med. 2022 Mar 1;182(3):303-312. doi: 10.1001/jamainternmed.2021.7866.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2016
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: November 8, 2016
• First Submitted That Met QC Criteria: November 21, 2016
• First Posted (Estimate): November 25, 2016

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: mHealth, Smoking cessation,
• Other Study ID Numbers: H00007427; R01CA190866-01A1 (U.S. NIH Grant/Contract); R25CA172009-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No