Tobacco Impact on Quality of Life on Snus-use, Dual Use, Smoke Use and Non-using.

Tobacco Impact on Quality of Life, a Cross-sectional Study on Snus-use, Dual Use, Smoke Use and Non-using.

The primary aim of this study was to compare HRQOL in snus-users and dual users (snus and smoking) with never tobacco users. Secondary aim included comparing HRQOL in smokers with non-smokers.

Study Overview

• Status: Completed
• Conditions: Tobacco Use

Detailed Description

Tobacco use is a major public health issue. The number of smokers decrease simultaneously as oral moist snuff (called "snus"), is promoted as a healthier alternative in spite its' negative health effects. Studies of health-related quality of life (HRQOL) of those who use snuff are lacking. Recruitment of 674 women and 605 men aged 18 to 65 years through a Swedish population data-base was performed for this cross-sectional study in southwestern Sweden. Subjects completed a questionnaire about tobacco use and the 36-item Short Form Health Survey (SF-36). The non-parametric Mann-Whitney test was used for statistical analysis.

• Study Type: Observational
• Enrollment (Actual): 3000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Three thousand women and men were randomly selected by the Swedish population data-base (SPAR) in rural areas of southwest Sweden.

Description

Inclusion Criteria:

Age 18 to 65 years

Exclusion Criteria:

not understand the Swedish language

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life was measured using SF-36.	The SF-36 collected data on perceived health status in eight domains: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE) and mental health (MH). The physical component summary (PCS) and mental component summary (MCS). Scores range from 0 to 100 with higher scores representing a higher perceived health	The time when the data entry is made, about 8 weeks
Tobacco habits.	The term pack-year (numbers of cigarettes / day * number of years / 20) and box-year (numbers of snuff boxes / week * number of years) was used to describe tobacco use. The variables smoking and snuff use were transformed from one pack-year to pack-decades by dividing pack-year by 10. Similarly, box-years were transformed to box-decades and age from years to decades.	The time when the data entry is made, about 8 weeks

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Study Director: Solbrith Wachsmann, DMPhil, Region Västra Götaland, Research, Education, Development & Innovation, Primary Care Research, Sweden; Principal Investigator: Gun Rembeck, PHD, Region Västra Götaland, Research, Education, Development & Innovation, Primary Care Research, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Quality of life; Health; Cigarette smoking; Population characteristics; Tobacco smokeless.
• Other Study ID Numbers: 65381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No