Very Brief Smoking Reduction Intervention

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

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.

Study Overview

• Status: Unknown
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Smoking reduction intervention; Behavioral: Exercise and diet advice control

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smoking reduction intervention arm; 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; 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.
Active Comparator: Control arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Publications and helpful links

General Publications

• Wu L, He Y, Jiang B, Zhang D, Tian H, Zuo F, Lam TH, Cheung YT. The effect of a very brief smoking-reduction intervention in smokers who have no intention to quit: study protocol for a randomized controlled trial. BMC Public Health. 2015 Apr 25;15:418. doi: 10.1186/s12889-015-1749-7.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (Estimate): February 24, 2015

Study Record Updates

• Last Update Posted (Estimate): February 24, 2015
• Last Update Submitted That Met QC Criteria: February 23, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: randomized controlled trial; smoking reduction intervention; no intention to quit; telephone follow-up intervention
• Other Study ID Numbers: ChinaPLAGHW