NCT02585206

Brief Summary

This study is comprised of 2 phases to study the impact of a text message system on overall adherence to a web-based smoking cessation program. Phase I uses a full factorial design to identify the most optimal text message intervention to maximize adherence to the BecomeAnEX.org smoking cessation program. Phase II is a randomized controlled trial that compares regular BecomeAnEX users to those who will receive the optimized text message intervention (from Phase I) in conjunction with BecomeAnEX for impact on long-term abstinence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,485

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration 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

First Submitted

Initial submission to the registry

October 22, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
2.4 years until next milestone

Study Start

First participant enrolled

March 29, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

1.7 years

First QC Date

October 22, 2015

Last Update Submit

February 12, 2021

Conditions

Smoking Cessation

Keywords

Mobile PhoneText MessagingInternetTobacco Use

Outcome Measures

Primary Outcomes (2)

  • Phase I - Composite adherence metric

    The investigators will create a composite metric of adherence for each Phase I participant using a weighted sum of their total number of number of visits, as well as of their page views, time on site, and use of the 6 interactive components of the site per visit during 3 months post-enrollment.

    3 months

  • Phase II - 30-day point prevalence abstinence

    Self-reported 30-day point prevalence abstinence at 9 months post randomization

    9 months post randomization

Secondary Outcomes (2)

  • Phase II - 30day point prevalence abstinence

    3 months post randomization

  • Phase II - 30day point prevalence abstinence

    15 months post randomization

Study Arms (18)

Arm 1

NO INTERVENTION

All 4 factors off - standard text message program Personalization OFF Integration OFF Dynamic Tailoring OFF Message Intensity OFF

Arm 2

ACTIVE COMPARATOR

Personalization OFF Integration OFF Dynamic Tailoring OFF Message Intensity ON

Behavioral: Message Intensity

Arm 3

ACTIVE COMPARATOR

Personalization OFF Integration OFF Dynamic Tailoring ON Message Intensity OFF

Behavioral: Dynamic Tailoring

Arm 4

ACTIVE COMPARATOR

Personalization OFF Integration OFF Dynamic Tailoring ON Message Intensity ON

Behavioral: Dynamic TailoringBehavioral: Message Intensity

Arm 5

ACTIVE COMPARATOR

Personalization OFF Integration ON Dynamic Tailoring OFF Message Intensity OFF

Behavioral: Integration

Arm 6

ACTIVE COMPARATOR

Personalization OFF Integration ON Dynamic Tailoring OFF Message Intensity ON

Behavioral: IntegrationBehavioral: Message Intensity

Arm 7

ACTIVE COMPARATOR

Personalization OFF Integration ON Dynamic Tailoring ON Message Intensity OFF

Behavioral: IntegrationBehavioral: Dynamic Tailoring

Arm 8

ACTIVE COMPARATOR

Personalization OFF Integration ON Dynamic Tailoring ON Message Intensity ON

Behavioral: IntegrationBehavioral: Dynamic TailoringBehavioral: Message Intensity

Arm 9

ACTIVE COMPARATOR

Personalization ON Integration OFF Dynamic Tailoring OFF Message Intensity OFF

Behavioral: Personalization

Arm 10

ACTIVE COMPARATOR

Personalization ON Integration OFF Dynamic Tailoring OFF Message Intensity ON

Behavioral: PersonalizationBehavioral: Message Intensity

Arm 11

ACTIVE COMPARATOR

Personalization ON Integration OFF Dynamic Tailoring ON Message Intensity OFF

Behavioral: PersonalizationBehavioral: Dynamic Tailoring

Arm 12

ACTIVE COMPARATOR

Personalization ON Integration OFF Dynamic Tailoring ON Message Intensity ON

Behavioral: PersonalizationBehavioral: Dynamic TailoringBehavioral: Message Intensity

Arm 13

ACTIVE COMPARATOR

Personalization ON Integration ON Dynamic Tailoring OFF Message Intensity OFF

Behavioral: PersonalizationBehavioral: Integration

Arm 14

ACTIVE COMPARATOR

Personalization ON Integration ON Dynamic Tailoring OFF Message Intensity ON

Behavioral: PersonalizationBehavioral: IntegrationBehavioral: Message Intensity

Arm 15

ACTIVE COMPARATOR

Personalization ON Integration ON Dynamic Tailoring ON Message Intensity OFF

Behavioral: PersonalizationBehavioral: IntegrationBehavioral: Dynamic Tailoring

Arm 16

ACTIVE COMPARATOR

Personalization ON Integration ON Dynamic Tailoring ON Message Intensity ON

Behavioral: PersonalizationBehavioral: IntegrationBehavioral: Dynamic TailoringBehavioral: Message Intensity

WEB

NO INTERVENTION

Phase II arm. Full access to standard BecomeAnEX.org web-based smoking cessation program.

WEB+OA_TXT

ACTIVE COMPARATOR

Phase II arm. Full access to standard BecomeAnEX.org web-based smoking cessation program PLUS optimal-adherence text message program from Phase I.

Behavioral: Optimal-Adherence Text

Interventions

PersonalizationBEHAVIORAL

Phase I Factor Personalized text messages using the participant's username and gender ("Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!"). Both data points will be pulled from BecomeAnEX registration data.

Arm 10Arm 11Arm 12Arm 13Arm 14Arm 15Arm 16Arm 9
IntegrationBEHAVIORAL

Phase I Factor Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention: Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online.

Arm 13Arm 14Arm 15Arm 16Arm 5Arm 6Arm 7Arm 8
Dynamic TailoringBEHAVIORAL

Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.

Arm 11Arm 12Arm 15Arm 16Arm 3Arm 4Arm 7Arm 8
Message IntensityBEHAVIORAL

Phase I Factor Varying levels of text message intensity over a 12-week period.

Arm 10Arm 12Arm 14Arm 16Arm 2Arm 4Arm 6Arm 8
Optimal-Adherence TextBEHAVIORAL

Optimal-adherence text message intervention developed in Phase I

Also known as: OA_TXT
WEB+OA_TXT

Eligibility Criteria

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

You may qualify if:

  • US residency
  • Current smoker
  • Access to and willingness to receive text messages on a mobile phone
  • Access to Internet
  • Access to and willingness to receive email communication from study personnel

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Truth Initiative

Washington D.C., District of Columbia, 20001, United States

Location

Related Publications (3)

  • Graham AL, Jacobs MA, Cohn AM, Cha S, Abroms LC, Papandonatos GD, Whittaker R. Optimising text messaging to improve adherence to web-based smoking cessation treatment: a randomised control trial protocol. BMJ Open. 2016 Mar 30;6(3):e010687. doi: 10.1136/bmjopen-2015-010687.

    PMID: 27029775BACKGROUND

  • Graham AL, Papandonatos GD, Cha S, Amato MS, Jacobs MA, Cohn AM, Abroms LC, Whittaker R. Effectiveness of an optimized text message and Internet intervention for smoking cessation: A randomized controlled trial. Addiction. 2022 Apr;117(4):1035-1046. doi: 10.1111/add.15677. Epub 2021 Sep 28.

    PMID: 34472676DERIVED

  • Graham AL, Papandonatos GD, Jacobs MA, Amato MS, Cha S, Cohn AM, Abroms LC, Whittaker R. Optimizing Text Messages to Promote Engagement With Internet Smoking Cessation Treatment: Results From a Factorial Screening Experiment. J Med Internet Res. 2020 Apr 2;22(4):e17734. doi: 10.2196/17734.

    PMID: 32238338DERIVED

MeSH Terms

Conditions

Smoking CessationTobacco Use

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Amanda L Graham, PhD

    Truth Initiative

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Phase I: full factorial design of four factors each with 2 levels (16 arms); Phase II: 2-arm randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Research Development

Study Record Dates

First Submitted

October 22, 2015

First Posted

October 23, 2015

Study Start

March 29, 2018

Primary Completion

December 19, 2019

Study Completion

July 10, 2020

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations

US(1)