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Trial registered on ANZCTR


Registration number
ACTRN12616000269437
Ethics application status
Approved
Date submitted
13/01/2016
Date registered
29/02/2016
Date last updated
29/02/2016
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 288296 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
smoking addiction 297259 0
smoking withdrawal symptoms 297260 0
Condition category
Condition code
Public Health 297461 297461 0 0
Health promotion/education
Mental Health 297462 297462 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 own path for change, at the same time providing them with a sense of autonomy. We assessed participants for their current stage of change and advised on physical activity to suit their current fitness levels. Advice also covered realistic goal setting and relapse prevention. Phone calls at Weeks 3 and 6 functioned as follow-ups with participants on their progress, as well as providing encouragement and motivation. The phone calls were also strategies to help monitor adherence. The intervention ended at Week 8 and follow up interviews (post-intervention) were conducted at Week 9 and Week 21.

Intervention code [1] 293593 0
Treatment: Other
Intervention code [2] 293594 0
Lifestyle
Intervention code [3] 293595 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297023 0
Participants' scores for withdrawal symptoms measured using the Shiffman-Jarvik Withdrawal Scale.
Timepoint [1] 297023 0
At Week 0 (baseline), Week 9 and Week 21
Primary outcome [2] 297024 0
Participants' scores for smoking cessation self-efficacy measured using the Cessation Self-Efficacy Questionnaire.


Timepoint [2] 297024 0
At Week 0 (baseline), Week 9 and Week 21
Primary outcome [3] 297025 0
Participants' scores for physical activity involvement measured using the International Physical Activity Questionnaire
Timepoint [3] 297025 0
At Week 0 (baseline), Week 9 and Week 21
Secondary outcome [1] 319877 0
Participants qualitative experiences with smoking cessation and the PAC, assessed through face-to-face post-intervention interviews.
Timepoint [1] 319877 0
At Week 9 and Week 21
Secondary outcome [2] 321043 0
Participants' scores for mood measured using the Brunel Mood Scale.

[Note: This is a primary outcome]
Timepoint [2] 321043 0
Week 0 (baseline), Week 9 and Week 21
Secondary outcome [3] 321044 0
Participants' scores for exercise self-efficacy measured using the Exercise Self-Efficacy Questionnaire.

[Note: This is a primary outcome]
Timepoint [3] 321044 0
Week 0 (baseline), Week 9 and Week 21

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Started smoking less than 6 months ago,

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7510 0
Malaysia
State/province [1] 7510 0
Wilayah Persekutuan Kuala Lumpur

Funding & Sponsors
Funding source category [1] 292673 0
University
Name [1] 292673 0
University of Malaya
Address [1] 292673 0
Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Country [1] 292673 0
Malaysia
Primary sponsor type
University
Name
Dr. Selina Khoo
Address
Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 291394 0
None
Name [1] 291394 0
None
Address [1] 291394 0
None
Country [1] 291394 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294144 0
Malaysian Ministry of Health Medical Research Ethics Committee
Ethics committee address [1] 294144 0
Secretariat of National Institutes of Health (NIHSEC)
c/o Institute for Health Management
Jalan Rumah Sakit, Bangsar
59000 Kuala Lumpur
Ethics committee country [1] 294144 0
Malaysia
Date submitted for ethics approval [1] 294144 0
Approval date [1] 294144 0
08/04/2013
Ethics approval number [1] 294144 0

Summary
Brief summary
In the present study, we examined the effectiveness of PAC as an adjunct to the standard smoking cessation treatment used in Malaysia. This study aimed to measure and monitor abstinence, changes in self-efficacy for physical activity, withdrawal, smoking cessation, and mood states at baseline, Week 9, and Week 21 of the study. We also aimed to explore individual experiences of participants who undergo a combined physical activity and smoking cessation intervention using in-depth interviews supported by tests of withdrawal, cessation self-efficacy, physical activity involvement, self-efficacy for physical activity and mood. We hypothesized that the PAC will help to increase physical activity involvement, physical activity self-efficacy, smoking cessation self-efficacy and decrease withdrawal symptoms and negative moods.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62682 0
Dr Selina Khoo
Address 62682 0
Pusat Sukan, Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Country 62682 0
Malaysia
Phone 62682 0
+60 3-7955 2595
Fax 62682 0
Email 62682 0
selina@um.edu.my
Contact person for public queries
Name 62683 0
Dr Selina Khoo
Address 62683 0
Pusat Sukan, Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Country 62683 0
Malaysia
Phone 62683 0
+60 3-7955 2595
Fax 62683 0
Email 62683 0
selina@um.edu.my
Contact person for scientific queries
Name 62684 0
Dr Selina Khoo
Address 62684 0
Pusat Sukan, Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Country 62684 0
Malaysia
Phone 62684 0
+60 3-7955 2595
Fax 62684 0
Email 62684 0
selina@um.edu.my

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary