Very Brief Smoking Reduction Intervention

Smoking Cessation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02370147
• Other study ID #: ChinaPLAGHW
• Status: Not yet recruiting
• Phase: N/A
• First received: February 10, 2015
• Last updated: February 23, 2015
• Start date: March 2015
• Est. completion date: June 2017

Study information

• Verified date: February 2015
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Aged =18 years old;

2. Smoked more than 10 cigarettes per day in the past month.

3. Have no intent to smoking cessation now.

4. Agreed to participate in the follow-up, offer telephone number and signed an informed consent form.

Exclusion Criteria:

1. Smoked less than 10 cigarettes per day in the past month.

2. Had some diseases that let the physician think that it would be unethical not to advise him to quit smoking as soon as possible.

3. Cognitively impaired (such as those with deafness or who could not understand and complete the questionnaire reliably).

4. Pregnant females.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Smoking reduction intervention
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.
• Exercise and diet advice control
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self-reported 7-day point prevalence quit rate		at 12 months follow-up	No
Primary	prolonged abstinence quit rate		at 12 months follow-up	No
Secondary	smoking reduction rates	number of cigarettes smoked per day reduced at least 50%	baseline and at 12 months follow-up	No