SurveyNCT04150510
Assessment of Smoking, Vaping, and Alcohol Consumption Behavior
An observational study of Survey and E-Cig Use, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
To assess smoking, vaping, and alcohol consumption behaviors via online surveys in the population. Further, the objective is to administer additional surveys to assess which methods (e.g., pen-and-paper records, a smartphone app) for monitoring smoking, vaping, alcohol intake, and food intake are preferred by the… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Survey, E-Cig Use, Smoking Behaviors
- How many people
- 3,245 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 6 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals aged 18 to 85 years who regularly engage in one or more of the following behaviors: * cigarette smoking * e-cigarette consumption (vaping) * alcohol consumption
Who may be able to join
- Individuals aged 18 to 85 years are eligible to complete the Demographics Questionnaire and the Food Intake Assessment Preference Questionnaire.
- Individuals in the same age range who regularly smoke cigarettes can complete the Smoking Questionnaire and the Smoking Assessment Preference Questionnaire, in addition to the Demographics Questionnaire and the Food Intake Assessment Preference Questionnaire
- Individuals in the same age range who regularly use e-cigarettes (vape) can complete the Vaping Questionnaire and the Vaping Assessment Preference Questionnaire, in addition to the Demographics Questionnaire and the Food Intake Assessment Preference Questionnaire
- Individuals in the same age range who regularly drink alcohol can complete the Alcohol Consumption Questionnaire and the Alcohol Consumption Assessment Preference Questionnaire, in addition to the Demographics Questionnaire and the Food Intake Assessment Preference Questionnaire
- Individuals who engage in several of these behaviors can complete all questionnaires that apply.
Who cannot join
- Individuals who are unwilling to participate in this survey
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70806
About this study
Official title: Online Survey to Assess Smoking, Vaping, and Alcohol Consumption Behavior in the Population
To assess smoking, vaping, and alcohol consumption behaviors via online surveys in the population. Further, the objective is to administer additional surveys to assess which methods (e.g., pen-and-paper records, a smartphone app) for monitoring smoking, vaping, alcohol intake, and food intake are preferred by the study population.
Read the detailed description
Many smokers believe that smoking helps them to control their weight, and concerns about weight gain can interfere with smoking cessation. In fact, nicotine has been shown to suppress appetite and increase resting metabolic rate, and smoking also serves as a behavioral alternative to eating or a distraction from hunger or food cravings. E-cigarettes are frequently marketed as the safer and healthier alternative to smoking, and some e-cigarettes are in fact actively advertised for weight management and/or suppression of food cravings, encouraging smokers to make the switch. In contrast, alcohol consumption has been shown to increase appetite and food intake and at the same time is associated with smoking and vaping.
Therefore, it is possible that participants who smoke or vape for weight control, particularly those who also regularly consume alcohol, would benefit from a lifestyle program that encompasses dietary counseling and exercise to prevent weight gain after smoking cessation. Additionally, methods to assess smoking, vaping, alcohol intake, and food intake (i.e., ingestive behaviors) historically relied on self-report, though the investigator's group has developed smartphone apps that allow people to capture images of their intake and/or self-report their intake in the app. App-based methods offer advantages, including the real-time transfer of data, and it is presumed that people will believe that apps are an easier and preferred method to capture ingestive behaviors, yet this assumption has not yet been thoroughly examined.
- Conditions
- Survey, E-Cig Use, Smoking Behaviors, Alcohol Drinking, Vaping, Food Intake
- Medical subject headings
- Vaping, Smoking, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Online Survey | Individuals who are willing to participate in this online survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic data
age, sex, race/ethnicity, marital status, education, employment status, household income, zip code, height and weight, the prevalence of cardiovascular risk factors and cancer, and food security status
Measured: Day of survey completion, up to 12 months
Smoking behavior
smoking status, history, frequency, amount, cues, motivation to quit, and potential factors affecting the decision to quit including the effect of smoking on food cravings
Measured: Day of survey completion, up to 12 months
Vaping behavior
vaping status, history, frequency, amount, cues, motivation to quit and potential factors affecting the decision to quit including the effect of vaping on food cravings
Measured: Day of survey completion, up to 12 months
Alcohol consumption
alcohol consumption status, history, frequency, amount, cues, motivation to quit/reduce consumption, and the effect of alcohol consumption on food cravings
Measured: Day of survey completion, up to 12 months
Secondary outcomes (4)
Smoking Assessment Preference
This questionnaire assesses the willingness to use different methods to monitor smoking behavior such as a pen-and-paper record or a smartphone app
Measured: Day of survey completion, up to 12 months
Vaping Assessment Preference
This questionnaire assesses the willingness to use different methods to monitor vaping behavior such as a pen-and-paper record or diary, a 24-hour recall, or a smartphone app
Measured: Day of survey completion, up to 12 months
Alcohol Consumption Assessment Preference
This questionnaire assesses the willingness to use different methods to monitor alcohol consumption such as a pen-and-paper record or diary, a 24-hour recall, or smartphone app-based methods (remote photography or in-app self-estimation of drink sizes)
Measured: Day of survey completion, up to 12 months
Food Intake Assessment Preference Questionnaire
This questionnaire assesses the willingness to use different methods to monitor food intake such as a pen-and-paper record or diary, a 24-hour recall, or smartphone app-based methods (remote food photography or in-app self-estimation of portion sizes)
Measured: Day of survey completion, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start1 Feb 2020
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurveyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 3,245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corby K. Martin, Pennington Biomedical Research Center
- Investigators
- Corby K Martin, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150510
- Sponsor's protocol ID
- 2019-052-PBRC
- Status last verified
- Apr 2021
- First submitted
- 28 Oct 2019
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to individual de-identified data is possible via Pennington Biomedical Research Center's Data Sharing policy.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Survey to Assess Smoking, Vaping, and Alcohol Consumption Behavior in the Population
- ClinicalTrials.gov ID
- NCT04150510
- Acronym / sponsor ID
- 2019-052-PBRC
- Conditions
- Survey, E-Cig Use, Smoking Behaviors, Alcohol Drinking, Vaping, Food Intake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,245 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess smoking, vaping, and alcohol consumption behaviors via online surveys in the population. Further, the objective is to administer additional surveys to assess which methods (e.g., pen-and-paper records, a smartphone app) for monitoring smoking, vaping, alcohol intake, and food intake are preferred by the study population.
Detailed description
Many smokers believe that smoking helps them to control their weight, and concerns about weight gain can interfere with smoking cessation. In fact, nicotine has been shown to suppress appetite and increase resting metabolic rate, and smoking also serves as a behavioral alternative to eating or a distraction from hunger or food cravings. E-cigarettes are frequently marketed as the safer and healthier alternative to smoking, and some e-cigarettes are in fact actively advertised for weight management and/or suppression of food cravings, encouraging smokers to make the switch. In contrast, alcohol consumption has been shown to increase appetite and food intake and at the same time is associated with smoking and vaping.
Therefore, it is possible that participants who smoke or vape for weight control, particularly those who also regularly consume alcohol, would benefit from a lifestyle program that encompasses dietary counseling and exercise to prevent weight gain after smoking cessation. Additionally, methods to assess smoking, vaping, alcohol intake, and food intake (i.e., ingestive behaviors) historically relied on self-report, though the investigator's group has developed smartphone apps that allow people to capture images of their intake and/or self-report their intake in the app. App-based methods offer advantages, including the real-time transfer of data, and it is presumed that people will believe that apps are an easier and preferred method to capture ingestive behaviors, yet this assumption has not yet been thoroughly examined.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online Survey | – | –Individuals who are willing to participate in this online survey |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals aged 18 to 85 years who regularly engage in one or more of the following behaviors: * cigarette smoking * e-cigarette consumption (vaping) * alcohol consumption
Key inclusion criteria (5 listed)
- Individuals aged 18 to 85 years are eligible to complete the Demographics Questionnaire and the Food Intake Assessment Preference Questionnaire.
- Individuals in the same age range who regularly smoke cigarettes can complete the Smoking Questionnaire and the Smoking Assessment Preference Questionnaire, in addition to the Demographics Questionnaire and the Food Intake Assessment Preference Questionnaire
- Individuals in the same age range who regularly use e-cigarettes (vape) can complete the Vaping Questionnaire and the Vaping Assessment Preference Questionnaire, in addition to the Demographics Questionnaire and the Food Intake Assessment Preference Questionnaire
- Individuals in the same age range who regularly drink alcohol can complete the Alcohol Consumption Questionnaire and the Alcohol Consumption Assessment Preference Questionnaire, in addition to the Demographics Questionnaire and the Food Intake Assessment Preference Questionnaire
- Individuals who engage in several of these behaviors can complete all questionnaires that apply.
Key exclusion criteria (1 listed)
- Individuals who are unwilling to participate in this survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic data
Time frame: Day of survey completion, up to 12 months
age, sex, race/ethnicity, marital status, education, employment status, household income, zip code, height and weight, the prevalence of cardiovascular risk factors and cancer, and food security status
Smoking behavior
Time frame: Day of survey completion, up to 12 months
smoking status, history, frequency, amount, cues, motivation to quit, and potential factors affecting the decision to quit including the effect of smoking on food cravings
Vaping behavior
Time frame: Day of survey completion, up to 12 months
vaping status, history, frequency, amount, cues, motivation to quit and potential factors affecting the decision to quit including the effect of vaping on food cravings
Alcohol consumption
Time frame: Day of survey completion, up to 12 months
alcohol consumption status, history, frequency, amount, cues, motivation to quit/reduce consumption, and the effect of alcohol consumption on food cravings
4 secondary outcomes
Smoking Assessment Preference
Time frame: Day of survey completion, up to 12 months
Vaping Assessment Preference
Time frame: Day of survey completion, up to 12 months
Alcohol Consumption Assessment Preference
Time frame: Day of survey completion, up to 12 months
Food Intake Assessment Preference Questionnaire
Time frame: Day of survey completion, up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: No. Access to individual de-identified data is possible via Pennington Biomedical Research Center's Data Sharing policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corby K Martin, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Survey and E-Cig Use, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic data (time frame: Day of survey completion, up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.