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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04150510
Other study ID # 2019-052-PBRC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2020
Est. completion date November 6, 2020

Study information

Verified date April 2021
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 study population.


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.


Recruitment information / eligibility

Status Completed
Enrollment 3245
Est. completion date November 6, 2020
Est. primary completion date November 6, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Locations

Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day of survey completion, up to 12 months
Primary 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 Day of survey completion, up to 12 months
Primary 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 Day of survey completion, up to 12 months
Primary Alcohol consumption 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 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 Day of survey completion, up to 12 months
Secondary 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 Day of survey completion, up to 12 months
Secondary 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) Day of survey completion, up to 12 months
Secondary 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) Day of survey completion, up to 12 months
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