Protocol summary

Study aim
To determine the effectiveness of WhaSTOP mHealth intervention plus usual care in movement through stages of change, smoking behaviour and knowledge among workers.
Design
Two arms parallel group quasi-experimental study
Settings and conduct
Among staffs at Universiti Teknologi MARA Selangor branch (Puncak Alam, Sungai Buloh, Selayang, Puncak Perdana, UiTM Hospital)
Participants/Inclusion and exclusion criteria
Participants: Smoker among workers Major inclusion criteria: Smoker in precontemplation and contemplation stages; aged 18 years and above; having a smartphone and able to use WhatApp. Major exclusion criteria: Participation in other smoking cessation programmes/services; on extended leave during the study period; unable to give informed consent to participate due to communication barrier, or impaired mental status or cognitive impairment.
Intervention groups
Participants will be allocated into 2 arms, the intervention and control groups. The intervention group will consist of 70 smokers who will receive the WhaSTOP module plus usual care. The participants will receive usual care (quit smoking pamphlets) during recruitment, then received 3-4 short videos per week via Whatsapp for 4 weeks duration. The control group will consist of 70 smokers who will receive usual care only. Comparison will be made between these groups before intervention (during recruitment), 4 weeks and 8 weeks after recruitment.
Main outcome variables
Stage movement, smoking knowledge, number of cigarettes per day, nicotine dependence level, quit attempt, smoking abstinence

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220415054539N1
Registration date: 2022-05-04, 1401/02/14
Registration timing: registered_while_recruiting

Last update: 2022-05-04, 1401/02/14
Update count: 0
Registration date
2022-05-04, 1401/02/14
Registrant information
Name
Syaharatul Patimah Kamarudin
Name of organization / entity
Universiti Teknologi MARA
Country
Malaysia
Phone
+60 3-6126 5000
Email address
dr.syaharatul@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-01, 1401/02/11
Expected recruitment end date
2022-08-31, 1401/06/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of WhaSTOP mHealth Intervention on Stages on Change of Smoking Behaviour among Workers
Public title
The Effects of WhaSTOP mHealth Intervention on Stages on Change of Smoking Behaviour among Workers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Smoker among workers Aged 18 years or above Being in the stages of precontemplation or contemplation based on the Transtheoretical Model Stage of Change, but are willing to take action to promote health Having a smartphone and being able to use WhatsApp for communication at least four days per week Willing to receive and commit to reading WhaSTOP intervention throughout the study period Able to understand and read in the Malay language
Exclusion criteria:
Participation in other smoking cessation programmes or services On extended leave during the study period Those who unable to give informed consent or participate in the study due to impaired mental status, cognitive impairment, or communication barrier
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Quasi-experimental

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Research Ethics Committee Universiti Teknologi Mara
Street address
UiTM Research Ethics Committee, Office of Deputy Vice Chancellor (Research and Innovation), Level 3 Bangunan Wawasan
City
Shah Alam
Postal code
40450
Approval date
2021-06-11, 1400/03/21
Ethics committee reference number
REC/06/2021 (MR/381)

Health conditions studied

1

Description of health condition studied
Smoker in precontemplation and contemplation stages
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Stage movement
Timepoint
Baseline (before intervention) and 4 and 8 weeks after intervention
Method of measurement
TTM constructs questionnaire - stages of change

2

Description
Number of cigarettes smoked per day
Timepoint
Baseline (before intervention) and 2, 4, 6 and 8 weeks after intervention
Method of measurement
Self-reported measure

Secondary outcomes

1

Description
Knowledge of smoking
Timepoint
Baseline (before intervention) and 4 and 8 weeks after intervention
Method of measurement
Global Adult Tobacco Survey (GATS) questionnaire

2

Description
Quit attempt
Timepoint
Baseline (before intervention) and 4 and 8 weeks after intervention
Method of measurement
Self-reported measure

3

Description
Smoking abstinence
Timepoint
Baseline (before intervention) and 4 and 8 weeks after intervention
Method of measurement
Self-reported measure

4

Description
Nicotine dependence level
Timepoint
Baseline (before intervention) and 4 and 8 weeks after intervention
Method of measurement
Fagerstrom Test of Nicotine Dependence Questionnaire

Intervention groups

1

Description
Intervention group will received WhaSTOP module and usual care (quit smoking pamphlet). The module consists of 14 educational and motivational videos on smoking behavior and cessation. Three to four videos will be delivered to the participants via Whatsapp every week for 4 weeks.
Category
Behavior

2

Description
Control group will received usual care (quit smoking pamphlet) during recruitment.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Universiti Teknologi MARA (UiTM) Kampus Sungai Buloh
Full name of responsible person
Syaharatul Patimah Kamarudin
Street address
Universiti Teknologi MARA Sungai Buloh Campus, Jalan Hospital
City
Sungai Buloh
Postal code
47000
Phone
+60 3-6126 5000
Email
dr.syaharatul@gmail.com
Web page address
https://ksb.uitm.edu.my/index.php/campuses/sungai-buloh-campus

2

Recruitment center
Name of recruitment center
UiTM Cawangan Selangor Kampus Puncak Alam
Full name of responsible person
Syaharatul Patimah Kamarudin
Street address
UiTM Cawangan Selangor Kampus Puncak Alam, Bandar Puncak Alam
City
Puncak Alam
Postal code
42300
Phone
+60 3-3258 4000
Email
dr.syaharatul@gmail.com
Web page address
https://ucs.uitm.edu.my/

3

Recruitment center
Name of recruitment center
UiTM Puncak Perdana Campus
Full name of responsible person
Syaharatul Patimah Kamarudin
Street address
Jalan Pulau Indah Au10/A, Puncak Perdana
City
Shah Alam
Postal code
40150
Phone
+60 3-7962 2000
Email
dr.syaharatul@gmail.com
Web page address
https://puncakperdana.uitm.edu.my/v3/index.php

4

Recruitment center
Name of recruitment center
Hospital UiTM
Full name of responsible person
Syaharatul Patimah Kamarudin
Street address
KS359 Pintu Utama UiTM
City
Bandar Puncak Alam
Postal code
42300
Phone
+60 3-3396 3000
Email
dr.syaharatul@gmail.com
Web page address
https://hospital.uitm.edu.my/index.php/en/

5

Recruitment center
Name of recruitment center
Universiti Teknologi MARA Selayang Campus
Full name of responsible person
Syaharatul Patimah Kamarudin
Street address
Jalan Prima Selayang 7
City
Batu Caves
Postal code
68100
Phone
+60 3-6126 4900
Email
dr.syaharatul@gmail.com
Web page address
https://medicine.uitm.edu.my/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Universiti Teknologi MARA
Full name of responsible person
Deputy Dean Research & Innovation
Street address
Universiti Teknologi MARA, Fakulti Perubatan Kampus Sungai Buloh, Jalan Hospital
City
Sungai Buloh
Postal code
47000
Phone
+60 3-6126 5000
Email
dr.syaharatul@gmail.com
Web page address
https://ksb.uitm.edu.my/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Universiti Teknologi MARA
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Universiti Teknologi MARA
Full name of responsible person
Syaharatul Patimah Kamarudin
Position
Postgraduate Student/ Doctorate Degree
Latest degree
Master
Other areas of specialty/work
Public Health/Community Medicine
Street address
Universiti Teknologi MARA, Fakulti Perubatan Kampus Sungai Buloh, Jalan Hospital, 47000 Sungai Buloh, Selangor
City
Sungai Buloh
Province
Selangor
Postal code
47000
Phone
+60 3-6126 5000
Fax
Email
2020631502@student.uitm.edu.my

Person responsible for scientific inquiries

Contact
Name of organization / entity
Universiti Teknologi MARA
Full name of responsible person
Syaharatul Patimah Kamarudin
Position
Postgraduate Student/ Doctorate Degree
Latest degree
Master
Other areas of specialty/work
Public Health/Community Medicine
Street address
Universiti Teknologi MARA, Fakulti Perubatan Kampus Sungai Buloh, Jalan Hospital, 47000 Sungai Buloh, Selangor
City
Sungai Buloh
Province
Selangor
Postal code
47000
Phone
+60 3-6126 5000
Fax
Email
2020631502@student.uitm.edu.my

Person responsible for updating data

Contact
Name of organization / entity
Universiti Teknologi MARA
Full name of responsible person
Syaharatul Patimah Kamarudin
Position
Postgraduate Student/ Doctorate Degree
Latest degree
Master
Other areas of specialty/work
Public Health/Community Medicine
Street address
Universiti Teknologi MARA, Fakulti Perubatan Kampus Sungai Buloh, Jalan Hospital, 47000 Sungai Buloh, Selangor
City
Sungai Buloh
Province
Selangor
Postal code
47000
Phone
+60 3-6126 5000
Fax
Email
2020631502@student.uitm.edu.my

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Published research report that contains all the findings of the study.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
people working in the academic area
Under which criteria data/document could be used
for scientific use
From where data/document is obtainable
scientific journal
What processes are involved for a request to access data/document
none
Comments
none
Loading...