NCT04623736

Brief Summary

The purpose of the study is to determine if using the smartphone application quitSTART can help people quit smoking and to understand how use of specific smartphone application features when trying to quit smoking is associated with success.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

October 19, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
Last Updated

November 10, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

October 30, 2020

Last Update Submit

November 9, 2021

Conditions

Keywords

Tobacco useSmoking cessationSmartphone applicationsmHealth

Outcome Measures

Primary Outcomes (2)

  • Self-reported 7-day smoking abstinence - 2 weeks

    "Have you smoked a cigarette (even a puff) in the past 7 days?" self-reported by the participant

    2 weeks

  • Self-reported 7-day smoking abstinence - 4 weeks

    "Have you smoked a cigarette (even a puff) in the past 7 days?" self-reported by the participant

    4 weeks

Secondary Outcomes (2)

  • Self-reported continuous smoking abstinence - 2 weeks

    2 weeks

  • Self-reported continuous smoking abstinence - 4 weeks

    4 weeks

Study Arms (1)

quitSTART

EXPERIMENTAL
Behavioral: quitSTART

Interventions

quitSTARTBEHAVIORAL

All participants will have access to the Smokefree.gov Initiative smoking cessation smartphone application, quitSTART. This app is available, at no cost, to anyone who owns a smartphone and is interested in quitting smoking. All smokers who download quitSTART are asked to provide basic information about themselves (e.g., age, sex, reason to quit smoking, triggers to smoke, when users typically smoke, how users plan to celebrate success, smoking frequency, age when started smoking regularly, ethnicity, race, cigarettes smoked per day), and set a quit date. Information about cessation and challenges to help support quitting are available, as well as games and tracking features. While using the app, users can proactively report cigarette cravings, if they slipped, if they are feeling "down" or feeling "great". If a user reports a craving, they have the option to mark the timing or location of the craving and request a reminder to resist future cravings at the same time or location.

quitSTART

Eligibility Criteria

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

You may qualify if:

  • Cigarette smoker
  • Smoked at least 100 cigarettes
  • Able to read and speak English
  • Owns a smartphone
  • years of age or older
  • USA resident

You may not qualify if:

  • Not a cigarette smoker
  • has not smoked at least 100 cigarettes
  • Not able to read and speak English
  • Does not own a smartphone
  • Under 18 years of age
  • Not a US resident
  • Currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

Related Publications (1)

  • Siegel LN, Wiseman KP, Budenz A, Prutzman Y. Identifying Patterns of Smoking Cessation App Feature Use That Predict Successful Quitting: Secondary Analysis of Experimental Data Leveraging Machine Learning. JMIR AI. 2024 May 22;3:e51756. doi: 10.2196/51756.

MeSH Terms

Conditions

Tobacco UseSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Officials

  • Kara P Wiseman

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 10, 2020

Study Start

October 19, 2020

Primary Completion

May 12, 2021

Study Completion

June 10, 2021

Last Updated

November 10, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

If requested, a de-identified dataset will be available to other researchers after the study is completed.

Shared Documents
STUDY PROTOCOL
Time Frame
After study completion

Locations