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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12616000269437
Date of registration: 29/02/2016
Prospective Registration: No
Primary sponsor: Dr. Selina Khoo
Public title: A Qualitative Study of the Efficacy of Physical Activity Consultation as an Adjunct to Standard Smoking Cessation Treatment in the Context of Malaysia
Scientific title: A Qualitative Study of the Efficacy of Physical Activity Consultation as an Adjunct to Standard Smoking Cessation Treatment in the Context of Malaysia
Date of first enrolment: 15/04/2013
Target sample size: 50
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12616000269437.aspx
Study type:  Interventional
Study design:  Purpose: Educational / counselling / training; Allocation: Non-randomised trial; Type of endpoint: Efficacy;  
Phase: 
Countries of recruitment
Malaysia
Contacts
Name: Dr Selina Khoo   
Address:  Pusat Sukan, Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia Malaysia
Telephone: +60 3-7955 2595
Email: selina@um.edu.my
Affiliation: 
Name: Dr Selina Khoo   
Address:  Pusat Sukan, Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia Malaysia
Telephone: +60 3-7955 2595
Email: selina@um.edu.my
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Males, over 18 years of age, smoked 10 or more cigarettes per day, the first cigarette smoked within 30 minutes of waking, and were not medically dependent or intellectually impaired.
Exclusion criteria: Started smoking less than 6 months ago,

Age minimum: 18 Years
Age maximum: No limit
Gender: Males
Health Condition(s) or Problem(s) studied
smoking addiction;smoking withdrawal symptoms;
smoking addiction
smoking withdrawal symptoms
Mental Health - Addiction
Public Health - Health promotion/education
Intervention(s)
The intervention is a combination of the standard smoking cessation treatment in Malaysia and Physical Activity Consultation (PAC).

PAC is a customized intervention that combines a number of techniques supported by research, including motivational interviewing, self-efficacy theory, including mastery goal setting, the Transtheoretical Model of Behaviour Change and relapse prevention. In this study, the PAC aimed to increase physical activity among smokers trying to quit smoking.

Smoking cessation consultation sessions were provided by a nurse with a counselling licence approved by the Malaysian Board of Counsellors. The nurse gave participants behavioural counselling and nicotine replacement therapy in the form of varenicline (Champix). Participants attended the clinic after one week for follow-up. Subsequent visits were scheduled by the clinic nurse depending on participants’ needs. These consultation sessions were conducted as often as needed by the participants until they were successfully abstinent.

Smokers who attended the clinic for the first time to seek smoking cessation treatment were invited to participate in the study. They were approached one week after their first smoking cessation consultation. This ensured participants established their smoking cessation program before starting another intervention.

PAC was conducted by a facilitator who maintained contact with participants for 21 weeks. PAC consisted of one face-to-face consultation session which lasted for 30 to 40 minutes and two follow-up phone sessions which lasted between 15 to 20 minutes. In the face-to-face consultation, we sought to understand participants’ level of physical activity, general view on physical activity, provide motivation and help them shape their
Primary Outcome(s)
Participants' scores for withdrawal symptoms measured using the Shiffman-Jarvik Withdrawal Scale.
[At Week 0 (baseline), Week 9 and Week 21]
Participants' scores for smoking cessation self-efficacy measured using the Cessation Self-Efficacy Questionnaire.


[At Week 0 (baseline), Week 9 and Week 21]
Participants' scores for physical activity involvement measured using the International Physical Activity Questionnaire [At Week 0 (baseline), Week 9 and Week 21]
Secondary Outcome(s)
Participants qualitative experiences with smoking cessation and the PAC, assessed through face-to-face post-intervention interviews.[At Week 9 and Week 21]
Participants' scores for exercise self-efficacy measured using the Exercise Self-Efficacy Questionnaire.

[Note: This is a primary outcome][Week 0 (baseline), Week 9 and Week 21]
Participants' scores for mood measured using the Brunel Mood Scale.

[Note: This is a primary outcome][Week 0 (baseline), Week 9 and Week 21]
Secondary ID(s)
None
Source(s) of Monetary Support
University of Malaya
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Malaysian Ministry of Health Medical Research Ethics Committee
Results
Results available:
Date Posted:
Date Completed:
URL:
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