Very Brief Smoking Reduction Intervention

Study Overview
=================
Brief Summary
-----------------
A two-arm randomized controlled trial for smokers who are not intent to quit smoking will be proposed in outpatient department clinics of People's Liberation Army General Hospital in Beijing, China. Smoking reduction intervention arm (SRI) consisting of a very brief face-to-face individual smoking reduction intervention lasted about one minute, and five follow-up interventions lasted for about minute each. Control arm (EDA) consisting of a very brief face-to-face individual exercise and dietetic advices lasted for the same intervention time as SRI, and also five follow-up interventions lasted for one minute each with different intervention contents.

Official Title
-----------------
The Effect of Very Brief Smoking Reduction Intervention in Smokers Who Having no Intention to Quit: Study Protocol for a Randomized Controlled Trial

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: Smoking reduction intervention
* Behavioral: Exercise and diet advice control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥18 years old; Smoked more than 10 cigarettes per day in the past month. Have no intent to smoking cessation now. Agreed to participate in the follow-up, offer telephone number and signed an informed consent form. Exclusion Criteria: Smoked less than 10 cigarettes per day in the past month. Had some diseases that let the physician think that it would be unethical not to advise him to quit smoking as soon as possible. Cognitively impaired (such as those with deafness or who could not understand and complete the questionnaire reliably). Pregnant females.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoking reduction intervention arm<br>Smoking reduction intervention arm (SRI) consisting of a minimal face-to-face individual smoking reduction intervention lasted for about one minute, and five follow-up interventions lasted for about one minute each. | Behavioral: Smoking reduction intervention<br>* Smokers was informed that many harmful effects were proved to be related with smoking, such as cancer, coronary heart disease, respiratory disease and many other health problems, and one out of two smokers will be killed by smoking. Smokers will be advised to reduce smoking consumption for at least half of their total consumption in the next month. Finally, all smokers were warned to keep in mind that the current attempt to reduce smoking is an intermediate step before the complete cessation.<br>|
| Active Comparator: Control arm<br>Control arm (UC) consisting of a brief face-to-face individual exercise and dietetic advices lasted for the same intervention time as SRI, and five follow-up interventions lasted for about one minute each with different intervention contents. | Behavioral: Exercise and diet advice control<br>* Smokers will be asked to do regular activities for three or four times per week, and to have a healthy and balanced diet, having more fruit and vegetables which are rich in vitamins, high in nutrition yet low in calories. In the whole process, advises will not refer to smoking cessation or smoking reduction.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-reported 7-day point prevalence quit rate |  | at 12 months follow-up | 
| prolonged abstinence quit rate |  | at 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoking reduction rates | number of cigarettes smoked per day reduced at least 50% | baseline and at 12 months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking reduction intervention, no intention to quit, randomized controlled trial, telephone follow-up intervention