NCT02497339

Brief Summary

This study has the following objectives:

  • The relationship between habitual response and learned association
  • The physiological and psychological withdrawal symptoms
  • Mindfulness yoga practices
  • Knowledge about impacts of smoking on women's health
  • Recapture the management of craving through mindfulness
  • Mindfulness exercises
  • Mindfulness yoga practices

Trial Health

87
On Track

Trial Health Score

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

Enrollment
215

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

July 9, 2015

Last Update Submit

May 10, 2016

Conditions

Smoking Cessation

Keywords

Smoking cessation interventionsmindfulness training

Outcome Measures

Primary Outcomes (1)

  • Self-reported quit rate for the past 7 days

    Quit rate of participants who stop smoking in the past 7 days

    6-month follow-up

Secondary Outcomes (2)

  • Biochemically validated quit rate

    6-month follow-up

  • 50% smoking reduction

    6-month follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention group (Mindfulness Smoking cessation program): Women in intervention group will be provided 2 sessions mindfulness training within 2 weeks. Each session will last for 2 hours with 8-20 participants. For mindfulness training, it aims to understand women smokers' own life planning, stressors and their correlation with smoking; to help women smokers sit with negative affect and alleviate stress through mindfulness; to educate women smokers gain the self-control and replace the smoking habit; to teach women smokers how to prevent craving and relapse.

Behavioral: Mindfulness training

Control group

EXPERIMENTAL

Control group (Self-help smoking cessation booklet): Only the self-help booklet related to quitting will be provided to the participants.

Behavioral: Mindfulness training

Interventions

Mindfulness trainingBEHAVIORAL

Using mindfulness training (Thinking and Yoga class) to help women smokers in workplaces to quit smoking

Control groupIntervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women who smoked at least 1 cigarette a day by the time of the study starts
  • Aged 18 or above
  • Able to communicate in Cantonese or Mandarin, and read and write Chinese

You may not qualify if:

  • Women smokers with unstable physical or psychological conditions as advised by a doctor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2/F, 61 Lung Kong Rd, Kowloon City, Lok Sin Tong Benevolent Society

Hong Kong, China

Location

Related Publications (2)

  • Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

    PMID: 39868569DERIVED

  • Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.

    PMID: 35420700DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Man-ping Wang, PhD

    School of Nursing, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2015

First Posted

July 14, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

CN(1)