NCT02973425

Brief Summary

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..

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
433

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
2 years until next milestone

Results Posted

Study results publicly available

August 11, 2022

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

3.7 years

First QC Date

November 8, 2016

Results QC Date

April 7, 2022

Last Update Submit

August 9, 2022

Conditions

Smoking Cessation

Keywords

mHealth, Smoking cessation,

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in Self-Efficacy at the End of the 6 Months

    6 months

  • Point Prevalent Cessation as Measured by Carbon Monoxide Levels

    6 months

  • Mean Number of Days Abstinent During the First 3 Weeks

    3 Weeks

  • Number of Participants Abstinent During the First 3 Weeks

    3 Weeks

Other Outcomes (4)

  • Number of Participants Completing Daily Challenge Quiz

    3 weeks

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

    1 week

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

    3 week

  • +1 more other outcomes

Study Arms (2)

NRT and mHealth assessment tool without feedback

ACTIVE COMPARATOR

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

Take a Break as an augmentation to NRT in Motivation

EXPERIMENTAL

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

Interventions

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

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

Take a Break as an augmentation to NRT in Motivation
NRT and mHealth assessment tool without feedbackBEHAVIORAL

NRT and mHealth assessment tool without feedback

NRT and mHealth assessment tool without feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Reliant Medical Group

Worcester, Massachusetts, 01605, United States

Location

VA Central Western Massachusetts Healthcare System

Worcester, Massachusetts, 01605, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Northwell Health

Great Neck, New York, 11030, United States

Location

Related Publications (1)

  • 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.

    PMID: 35072714DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Results Point of Contact

Title
Rajani Sadasivam
Organization
UMass Chan Medical School
Rajani.Sadasivam@umassmed.edu
15088568923

Study Officials

  • Rajani S Sadasivam, PhD

    UMMS

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 25, 2016

Study Start

November 7, 2016

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

August 11, 2022

Results First Posted

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(4)