NCT03480113

Brief Summary

The present study will carry out a workplace health promotion via MBI to help smoking workers to quit smoking.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

March 16, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

March 14, 2018

Last Update Submit

May 17, 2018

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Nicotine dependence level

    Fagerstrom Dependence Questionnaire was adopted to assess the level of Nicotine dependence

    Up to 8 months

Secondary Outcomes (4)

  • Self-reported stress

    Up to 8 months

  • Psychological distress

    Up to 8 months

  • the Level of mindfulness

    Up to 8 months

  • the level of CO

    Up to 8 months

Study Arms (2)

Mindfulness-based Intervention

EXPERIMENTAL

1 session of health education regrading the harms from smoking and 6 sessions of Mindfulness-based intervention, 1 hour each session.

Behavioral: Mindfulness-based Intervention

Physical Fitness intervention

ACTIVE COMPARATOR

1 session of health education regrading the harms from smoking and 6 sessions of physical fitness and stretch exercise, 1 hour each session.

Behavioral: Physical fitness intervention

Interventions

Mindfulness-based InterventionBEHAVIORAL

mindful breath, body scan, sitting meditation and walking meditation and so on.

Mindfulness-based Intervention
Physical fitness interventionBEHAVIORAL

giving the lessons of stretch exercise, aerobics to strength muscle and lung fuctions.

Physical Fitness intervention

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • volunteered employees with heavy smoker
  • Full-time paid workers

You may not qualify if:

  • Age \< 20y or \> 65y
  • Part-time workers
  • The workers are not willing to take part in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIDC

Taichung, 433, Taiwan

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Shu-Ling Huang, PhD

    Department of Psychology, Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Ling Huang, PhD

CONTACT

+886-4-24730022shuling@csmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 14, 2018

First Posted

March 29, 2018

Study Start

March 16, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

May 18, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)