Clinical trial NCT03339206: Enhancing Source Credibility in Tobacco Regulatory Communications
Official title: Enhancing Source Credibility in Tobacco Regulatory Communications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking Behavior
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-11-13
Enrollment: 845
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: The Family Smoking Prevention and Tobacco Control Act delegates the U.S. Food and Drug Administration (FDA) to communicate the risks of smoking to the public, among other tobacco regulatory responsibilities. Little research exists about how FDA, as a regulatory agency, should develop and deliver these messages, and whether they should include their source information on the ads. This study will assess the impact of cigarette constituent messages with and without FDA source and quit information in a randomized controlled trial.

Recruitment: People interested in participating will complete an online screener. Study staff will invite people eligible based on the screener to enroll in the study.

Informed Consent: The consent form will be shared with people who are eligible based on the screener in the invitation email. At the beginning of the baseline survey, participants will again review the consent form and will be asked to provide consent in order to enroll in the study.

Randomization: At the end of the baseline survey, survey software will randomly assign participants to one of the three study arms. Participants will have an equal chance of being randomized to each study arm.

Assessment: Participants will complete 18 computer based surveys during the study. The first baseline survey will take around 20 minutes to complete on day 0. Participants will then receive a survey each morning for days 1-15 that will include behavior measures as well as their assigned study intervention. These surveys will take approximately 5 minutes to complete. Participants will then complete a 20-minute survey on day 16, and day 32.

Detailed description of the intervention: Participants will receive an email with a link to a survey each morning for 15 days. During that survey they will be shown one message from their condition. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators designed the messages.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Quit Intentions
timeFrame: day 16
Secondary outcomes:
measure: Number of Cigarettes Smoked Each Day
timeFrame: days 1-15
measure: Number of Cigarettes Forgone Each Day
timeFrame: days 1-15
measure: Number of Cigarettes Butted Out Each Day
timeFrame: days 1-15
measure: Quit Attempts During the Study
timeFrame: days 16 and 32
measure: Awareness of Quitline
timeFrame: day 16
measure: Recall of Quitline Phone Number
timeFrame: day 16
measure: Use of Quitline During the Study
timeFrame: days 16 and 32
measure: Intention to Use the Quitline
timeFrame: days 16 and 32
measure: Quit Intentions
timeFrame: day 32
measure: Self Efficacy
timeFrame: days 16 and 32
measure: Response Efficacy
timeFrame: days 16 and 32
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
References:
citation: 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.