The effect of a very brief smoking-reduction intervention in smokers who have no intention to quit: Study protocol for a randomized controlled trial

Abstract

BACKGROUND: Tobacco use is one of the most common preventable causes of death, but more than half of the Chinese men still use tobacco products. Moreover, 63.6% of Chinese smokers have stated that they would not consider quitting. Specialized and intensive smoking-cessation services are too expensive and passive to have major clinical and public health impacts in developing countries like China. Smoking cessation medications are not covered by medical insurance, and their high price prevents Chinese smokers from using them. Brief interventions are needed to provide cost-effective and timesaving tobacco dependence treatments in China mainland. METHODS/DESIGN: We describe a two-arm randomized controlled trial for smokers who have no intention to quit. The project will be conducted in outpatient clinics at a large hospital in Beijing, China. Both arms include one face-to-face interview plus five follow-up interventions. Each intervention will last approximately one minute. Subjects allocated to the smoking-reduction intervention arm (SRI) will be advised to reduce smoking consumption to at least half of their current consumption level within the next month. All subjects in the SRI will be warned to bear in mind that an attempt to reduce smoking is an intermediate step before complete cessation. Smokers who have successfully reduced their smoking consumption will be encouraged to completely cease smoking. Controls are subjects allocated to the exercise- and diet-advice arm (EDA) and will be given advice about healthy diet and physical activity, but the advice will not include smoking cessation or reduction. Data collection will be done at baseline and at each follow-up interview using standardized questionnaires. The primary outcomes include self-reported and biochemically verified 7-day point prevalence and prolonged abstinence rates at 12-month follow-up. DISCUSSION: We expect that an intention to quit in smoking outpatients can be motivated by physicians in the clinic setting. If this very brief smoking-reduction intervention can be demonstrated to have a positive impact on long-term smoking cessation, this strategy has the potential to be a viable and acceptable approach and may be used widely in China and elsewhere. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02370147 (date of registration: 23th February, 2015).