Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior

Sponsor
University of Vermont (Other)
Overall Status
Completed
CT.gov ID
NCT04805515
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
794
1
2
3.5
223.8

Study Details

Study Description

Brief Summary

This is a 2-arm, randomized controlled, population based trial to test the impact of multiple exposures to brief nicotine corrective messages among adult tobacco cigarette smokers and non-smokers followed in waves over 12 weeks. The primary outcome, assessed at wave 1 (baseline), wave 2 (weeks 5-6), and wave 4 (weeks 11-13) is nicotine beliefs. Secondary outcomes assessed at the same time points include intention to use nicotine/tobacco products and nicotine/tobacco use.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Nicotine Corrective Messages
N/A

Detailed Description

This is a 2-arm, randomized controlled, population based trial to test the impact of multiple exposures to brief nicotine corrective messages among adult tobacco cigarette smokers and non-smokers followed for 12 weeks. The primary outcome, assessed at wave 1 (baseline), wave 2 (weeks 5-6), and wave 4 (weeks 11-13) is nicotine beliefs. Secondary outcomes assessed at the same time points include intention to use nicotine/tobacco products and nicotine/tobacco use. All participants will be recruited from a US national consumer research panel. Eligible participants will be U.S. adults ages 18+ who are enrolled members of the partnering consumer research panel. The sample will include non-smokers and smokers, oversampling current smokers (defined as smoking 100+ lifetime cigarettes and now smoking all or some days) to ensure the proportion of smokers in the sample reflects the ~15 % population smoking prevalence among adults. Panel members will be contacted by email with a brief study description and link to an eligibility screener and online informed consent form. Eligible and interested participants will complete the baseline (Wave 1) survey measures of nicotine beliefs and intentions/use of nicotine and tobacco products, after which they will be randomly assigned in equal numbers to the nicotine corrective message (NCM) intervention condition or the delayed message control condition. After completing the baseline survey, participants in the NCM condition will receive their first exposure to the corrective messages. In the Wave 2 survey, all participants will complete measures of nicotine beliefs and intentions/use of nicotine and tobacco products. Participants in the NCM condition will then receive their second exposure to study messages. Only participants in the NCM condition will receive the Wave 3 survey, which involves the third exposure to study messages. The Wave 4 survey will include the fourth exposure to study messages for those in the NCM condition and the final assessment of nicotine beliefs and intentions/use of nicotine and tobacco products for all participants. Upon completion of the final assessment, participants in the control condition will be exposed to the nicotine corrective messages and all participants will be directed to resources on quitting smoking.

Study Design

Study Type:
Interventional
Actual Enrollment :
794 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The intervention consists of 8 brief nicotine corrective public education messages delivered online. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes.The intervention consists of 8 brief nicotine corrective public education messages delivered online. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior
Actual Study Start Date :
Feb 12, 2021
Actual Primary Completion Date :
May 31, 2021
Actual Study Completion Date :
May 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nicotine Corrective Messages

Participants in the nicotine corrective messages condition will receive 8 brief nicotine corrective public education messages delivered online during 4 waves of the 12 week study. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes.

Behavioral: Nicotine Corrective Messages
Messages communicating misperceptions of nicotine's role in health harms as well as misperceptions about reduced nicotine content cigarettes and e-cigarettes.

No Intervention: Delayed Message Control

Participants in the control condition will be exposed to the nicotine corrective messages after the completion of the final assessment at the end of the 12 week study.

Outcome Measures

Primary Outcome Measures

  1. Nicotine beliefs [Wave 4 (weeks 11-13)]

    8 items assessing nicotine beliefs, 4 items assessing nicotine false beliefs, 6 items assessing nicotine replacement therapy (NRT) false beliefs, 4 items assessing e-cigarette false beliefs, 11 items assessing reduced nicotine content (RNC) cigarette false beliefs, and two items assessing beliefs about additive-free and organic tobacco products. Higher scale scores indicate a higher number of false beliefs. Nicotine beliefs relate specifically to its addictive nature, nicotine as a cause of cancer, and the role of nicotine in the health harms and cancer caused by smoking. The product-specific constructs (i.e., NRT, e-cigarette, RNC cigarette) include items related to the addictiveness of the product and the perceived health risks of the product compared to regular cigarettes. Two items regarding beliefs about additive-free and organic tobacco products (topics not addressed in the NCM intervention) evaluate whether effects on beliefs are specific to the manipulation.

Secondary Outcome Measures

  1. Intention to use nicotine/tobacco products [Wave 4 (weeks 11-13)]

    Four items assessing intention to use tobacco cigarettes, e-cigarettes, NRT, and RNC cigarettes during the next 12 months. Adapted from PhenX Toolkit- Susceptibility to Tobacco Products, response options Definitely Yes; Probably Yes; Probably Not; Definitely Not.

  2. Tobacco use [Wave 4 (weeks 11-13)]

    Number of days used tobacco in the past 30 days. Days used summed across eight different nicotine/tobacco products (e.g., tobacco cigarettes, e-cigarettes, cigars, NRT, RNC cigarettes).

Other Outcome Measures

  1. Attitudes about nicotine [Wave 4 (weeks 11-13)]

    Three items on nicotine-related attitudes using semantic differentials across five-point Likert scales. 'Using Nicotine is:' Safe (1) - Dangerous (5); Positive (1) - Negative (5); Good (1) - Bad (5).

  2. Nicotine related norms [Wave 4 (weeks 11-13)]

    Two items: "How would you describe most people's opinion of using nicotine?" and "Thinking about the people who are important to you, how would you describe their opinion on using nicotine?" with five-point Likert scale responses ranging from "very positive" to "very negative." One item: "How socially acceptable among you peers do you think each of the following products are from 1= not at all to 5= extremely. One item "Rank the following three uses of nicotine in terms of their social acceptability to you and people like you." From 1= most acceptable to 3=least acceptable

  3. Behavioral control [Wave 4 (weeks 11-13)]

    One item assessing confidence to resist smoking cigarettes when others are smoking (0=not at all confident to 3=very confident) and among current tobacco users, one item assessing confidence to quit smoking/tobacco use for good (0=not at all confident to 3=very confident). For past 30 day tobacco users, one item assessing importance of stopping tobacco use (0 to 10 scale, where 0= not at all), one item assessing readiness to quit within the next month (0 to 10 scale, where 0= not at all) and one item assessing confidence to quit within the next month (0 to 10 scale, where 0= not at all).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • US resident age 18+

  • Member of the partnering consumer research panel conducting the survey

  • Non-smokers and tobacco cigarette smokers

Exclusion Criteria:
  • Age less than 18

  • Not a member of the partnering consumer research panel conducting the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Vermont Burlington Vermont United States 05405

Sponsors and Collaborators

  • University of Vermont
  • National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Andrea C Villanti, PhD, MPH, University of Vermont

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andrea Villanti, Principal Investigator, University of Vermont
ClinicalTrials.gov Identifier:
NCT04805515
Other Study ID Numbers:
  • 00001374
  • R01DA051001
First Posted:
Mar 18, 2021
Last Update Posted:
Aug 30, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 30, 2021