Enhancing Source Credibility in Tobacco Regulatory Communications

NCT03339206 | Completed Results

• 2 other identifiers: 17-0610P50CA180907
• Study Type: interventional
• Target: 845
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the impact of cigarette constituent messages with and without FDA source and quit information in a randomized controlled trial. The investigators hypothesize that cigarette constituent messages will increase intention to quit compared to messages about littering cigarettes (the control). The investigators also hypothesize that constituent messages that include FDA source and quit information will increase intention to quit compared to messages without that information.

Conditions

Cigarette Smoking Behavior

Outcome Measures

Primary Outcomes (1)

• Quit Intentions

  Average quit intention score measured at 16 days by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.

  day 16

Secondary Outcomes (11)

• Number of Cigarettes Smoked Each Day

  days 1-15

• Number of Cigarettes Forgone Each Day

  days 1-15

• Number of Cigarettes Butted Out Each Day

  days 1-15

• Quit Attempts During the Study

  days 16 and 32

• Awareness of Quitline

  day 16

Study Arms (3)

Constituent message with FDA and quitline

EXPERIMENTAL

Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm will also include an FDA logo, and information about the benefits of quitting smoking and the quitline. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team.

Behavioral: Constituent message with FDA and quitline

Constituent message without FDA and quitline

EXPERIMENTAL

Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm is identical to the arm above, except that it does not include FDA source or quit information. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team.

Behavioral: Constituent message without FDA and quitline

Littering message (Control)

OTHER

Messages about littering cigarettes will include text designed to discourage people from littering their cigarette butts, and an image related to the message. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team.

Behavioral: Littering message (Control)

Interventions

Constituent message with FDA and quitline BEHAVIORAL

Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm will also include an FDA logo, and information about the benefits of quitting smoking and the quitline. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team.

Constituent message with FDA and quitline

Constituent message without FDA and quitline BEHAVIORAL

Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm is identical to the arm above, except that it does not include FDA source or quit information. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team.

Constituent message without FDA and quitline

Littering message (Control) BEHAVIORAL

Messages about littering cigarettes will include text designed to discourage people from littering their cigarette butts, and an image related to the message. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team.

Littering message (Control)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have smoked at least 100 cigarettes in his or her lifetime
• Currently smoke cigarettes every day or some days
• Work or home access to the internet
• Email account that is regularly used
• Lives in the US
• Comfortable taking a survey in English
• Able to complete a survey on a computer
• Able to complete surveys delivered via email
• Able to complete 3, 20 minute surveys during the study
• Able to complete surveys in the morning for 15 days

You may not qualify if:

• Currently using pharmacotherapy, a quitline, or a quit smoking program or support group for smoking cessation
• Participated in a research study about smoking cigarettes or using other tobacco products in the last 3 months

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Goldstein AO, Jarman KL, Kowitt SD, Queen TL, Kim KS, Shook-Sa BE, Sheeran P, Noar SM, Ranney LM. Effect of Cigarette Constituent Messages With Engagement Text on Intention to Quit Smoking Among Adults Who Smoke Cigarettes: A Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e210045. doi: 10.1001/jamanetworkopen.2021.0045.

  PMID: 33625509 DERIVED

MeSH Terms

Conditions

Cigarette Smoking

Interventions

United States Food and Drug Administration

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

United States Public Health Service; United States Dept. of Health and Human Services; United States Government Agencies; Federal Government; Government; Organizations; Health Care Economics and Organizations

Results Point of Contact

• Title: Adam O. Goldstein
• Organization: University of North Carolina at Chapel Hill

adam_goldstein@med.unc.edu

984-974-0210

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 13, 2017
• Study Start: October 10, 2017
• Primary Completion: May 6, 2018
• Study Completion: May 23, 2018
• Last Updated: November 24, 2020
• Results First Posted: November 24, 2020

Record last verified: 2020-11

Locations

US (1)