NCT02370147

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 24, 2015

Status Verified

February 1, 2015

Enrollment Period

1.8 years

First QC Date

February 10, 2015

Last Update Submit

February 23, 2015

Conditions

Keywords

smoking reduction interventionno intention to quitrandomized controlled trialtelephone follow-up intervention

Outcome Measures

Primary Outcomes (2)

  • self-reported 7-day point prevalence quit rate

    at 12 months follow-up

  • prolonged abstinence quit rate

    at 12 months follow-up

Secondary Outcomes (1)

  • smoking reduction rates

    baseline and at 12 months follow-up

Study Arms (2)

Smoking reduction intervention arm

EXPERIMENTAL

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

Control arm

ACTIVE COMPARATOR

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

Interventions

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.

Smoking reduction intervention arm

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.

Control arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Smoking Cessation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Institute of Geriatrics

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 24, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

February 24, 2015

Record last verified: 2015-02