Clinical trial NCT05508672: Community-Centered eHealth Smoking Cessation Intervention(CCeSCI)
Official title: Community-Centered eHealth Smoking Cessation Intervention Based on the "Smoking Rationalization Beliefs" Framework for Chinese Male Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lifestyle, Healthy
Keywords: Smoking Cessation
Disease control and prevention
Health management
Effectiveness evaluation
Lead sponsor: Duke Kunshan University
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 60
Sex: MALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Recent findings regarding why Chinese male smokers are reluctant to quit have offered insight for a possible new solution. Consistent with the Cognitive Dissonance Theory, "smoking rationalization beliefs" are a set of beliefs by smokers to rationalize their smoking behavior and avoid quitting. These beliefs have been well studied by global researchers, and a "smoking rationalization beliefs" scale was recently developed and validated for Chinese male smokers. The six dimensions of these beliefs are: smoking functional beliefs, risk generalization beliefs, social acceptability beliefs, safe smoking beliefs, self-exempting beliefs, and quitting is harmful beliefs. Studies on smoking rationalization in China have primarily been observational. Investigators propose to develop a Community-Centered eHealth Smoking Cessation Intervention (CCeSCI). The trinity of CCeSCI are the triangular unity of "smoking rationalization beliefs" framework, the non-physician community workers, and the eHealth technologies. The latter two were previously proven effective in interventional studies (including three conducted by the PI) but not yet widely used in smoking cessation. With the adoption of smoking rationalization beliefs framework aiming to address the cognitive causes of phycological addition to smoking and supported by the community-based behavioral interventions and the use of eHealth, CCeSCI is designed to overcome previous challenges with the principles of people-centeredness, convenience, and personalization.

Detailed description: Investigators will firstly evaluate the feasibility of CCeSCI. Once CCeSCI is ready to deploy, investigators will recruit 60 smokers (male, 25-64 years old) in two communities in Qingpu to conduct a pilot non-blinded randomized controlled trial. They will be randomized in a 1:1 ratio into either the intervention group to receive CCeSCI or the control group to receive the traditional "smoking is harmful" education video. Investigators will also use qualitative research methods (one on one interviews) to conduct process evaluations at 4th, 8th, and 12th weeks according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. At the end of the 12th week after the participants joined the RCT, saliva samples will be collected by community workers and quitting outcomes will be biochemically verified by a third party lab.

Eligibility criteria: Inclusion Criteria:

1. Male, current cigarette smokers who are willing to quit
2. Citizens who currently reside in Qingpu District, Shanghai, China
3. Age 25-64
4. Smoking index greater than or equal to 100 (smoking index = average number of cigarettes smoked per day × years of smoking)
5. Able to understand mandarin Chinese
6. Willing to provide informed consent to participate in the study

Exclusion Criteria:

1. Ever or currently on pharmacologic treatments, including various forms of NRT formulations such as gum, transdermal patch, nasal spray, oral inhaler, lozenge, Bupropion, Varenicline and newly emerged precision medicine
2. Currently participating in other individual-based cessation program(s), such as psychological counseling, behavioral therapy etc.
3. Currently under treatment of life-threatening medical conditions or critically ill
4. Unable to make commitment of a consecutive 4-hour video viewing
5. Plan to move out of the community in the next 3 month

Primary outcomes:
measure: Biochemically verified continuous smoking abstinence at 3 month
timeFrame: 3 month
Secondary outcomes:
measure: Fagerstrom Test For Nicotine Dependence (FTND) Score
timeFrame: Change from baseline to 3-month follow up
measure: Patient Health Questionnaire-9
timeFrame: Change from baseline to 3-month follow up
measure: Self-reported 7-day point smoking status
timeFrame: 3-month follow up
measure: Self-reported continuous abstinence at 3 month
timeFrame: 3-month follow up
measure: Self-reported average number of cigarettes
timeFrame: Change from baseline to 3-month follow up
measure: Smoking Rationalization Scale
timeFrame: Change from baseline to 3-month follow up
measure: Questionnaire about community health workers' Knowledge, Attitude and Practices (KAP)
timeFrame: 3-month follow up
measure: Weight in kilograms
timeFrame: Change from baseline to 3-month follow up
measure: Blood Pressure
timeFrame: Change from baseline to 3-month follow up
measure: Waist Circumference
timeFrame: Change from baseline to 3-month follow up
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Qingpu Patriotic Hygiene and Health Promotion Guidance Center
state: Shanghai
Study officials:
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