- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04150510
Assessment of Smoking, Vaping, and Alcohol Consumption Behavior
Online Survey to Assess Smoking, Vaping, and Alcohol Consumption Behavior in the Population
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70806
- Pennington Biomedical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
• Individuals who are unwilling to participate in this survey
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Online Survey
Individuals who are willing to participate in this online survey
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day of survey completion, up to 12 months
|
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
|
Day of survey completion, up to 12 months
|
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
|
Day of survey completion, up to 12 months
|
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
|
Day of survey completion, up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking Assessment Preference
Time Frame: Day of survey completion, up to 12 months
|
This questionnaire assesses the willingness to use different methods to monitor smoking behavior such as a pen-and-paper record or a smartphone app
|
Day of survey completion, up to 12 months
|
Vaping Assessment Preference
Time Frame: Day of survey completion, up to 12 months
|
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
|
Day of survey completion, up to 12 months
|
Alcohol Consumption Assessment Preference
Time Frame: Day of survey completion, up to 12 months
|
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)
|
Day of survey completion, up to 12 months
|
Food Intake Assessment Preference Questionnaire
Time Frame: Day of survey completion, up to 12 months
|
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)
|
Day of survey completion, up to 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Corby K Martin, PhD, Pennington Biomedical Research Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-052-PBRC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Drinking
-
University of North Carolina, Chapel HillNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingDrinking Behavior | Adolescent Behavior | Drinking, Alcohol | Alcohol Drinking, AdolescentUnited States
-
University of Auckland, New ZealandTe Hiringa Hauora/Health Promotion AgencyCompletedDrinking, Alcohol | Consumption, AlcoholNew Zealand
-
Boston University Charles River CampusRecruiting
-
University of ArkansasRecruitingDrinking Behavior | Drinking Excessive | DrinkingUnited States
-
Butler HospitalNational Institute of General Medical Sciences (NIGMS)CompletedDrinking, AlcoholUnited States
-
Real Prevention, LLCCompletedUnderage Drinking | Alcohol Use, UnderageUnited States
-
Universidad de GranadaCompletedExercise | Drinking, AlcoholSpain
-
University of FloridaNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Active, not recruiting
-
University of North Texas Health Science CenterNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Completed
-
University of MinnesotaNational Institute on Alcohol Abuse and Alcoholism (NIAAA); University of Michigan and other collaboratorsCompleted