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Trial registered on ANZCTR


Registration number
ACTRN12624000132549
Ethics application status
Approved
Date submitted
9/01/2024
Date registered
13/02/2024
Date last updated
13/02/2024
Date data sharing statement initially provided
13/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a faith-based intervention to quit smoking during Ramadan 2024.
Scientific title
Testing the efficacy of a text-message faith-based smoking cessation intervention for Muslims in Ramadan: A pilot randomised controlled trial.
Secondary ID [1] 311278 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cigarettes smoking. 332518 0
Waterpipe smoking 332678 0
Condition category
Condition code
Public Health 329203 329203 0 0
Other public health
Mental Health 329386 329386 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A behavioural faith-based intervention for smoking cessation. The intervention consists of religious-based messages and health messages. The messages were informed by qualitative interviews with current and former Muslim smokers and co-designed with religious scholars. The intervention will be text-message-based; each text message will be less than 500 words. The health messages include providing information on the harm of smoking, the benefits of quitting, and strategies to overcome cravings. The health messages are supported by religious messages from the Quran (Islami holy book) and Hadith (Prophet Mohammed's teachings). Participants will receive daily text messages during Ramadan 2024 (over 30 days) and one month post-Ramadan. In the first 15 days of Ramadan, participants will receive two messages per day. In the last 15 days, they will receive one message per day. After Ramadan, participants will receive three weekly messages for four weeks to enhance smoking cessation support. To monitor protocol adherence, participants will be sent a weekly questionnaire asking if they read the messages.
Intervention code [1] 327730 0
Behaviour
Comparator / control treatment
The control group will receive text messages about health and behaviour change techniques not supported by religious messages. Each message will be less than 300 words. The messages will be drawn from the literature on smoking cessation behaviour change techniques and the txt2stop messaging library, including information on the harm of smoking, the benefits of quitting, and strategies to overcome cravings. Similar to the intervention group, the control group will receive daily text messages during Ramadan 2024 (over 30 days) and one month post-Ramadan. In the first 15 days of Ramadan, participants will receive two messages per day. In the last 15 days, they will receive one message per day. After Ramadan, participants will receive three weekly messages for four weeks to enhance smoking cessation support. To monitor protocol adherence, participants will be sent a weekly questionnaire asking if they read the messages.
Control group
Active

Outcomes
Primary outcome [1] 337041 0
Smoking cessation
Assessment method [1] 337041 0
7-day point-prevalence abstinence. This will be collected through an online questionnaire.
Timepoint [1] 337041 0
Three months after the start of Ramadan (i.e., three months after starting the intervention).
Secondary outcome [1] 430452 0
Intervention acceptability
Assessment method [1] 430452 0
The generic theoretical framework of acceptability (TFA-based) questionnaire. This will be collected through an online questionnaire.
Timepoint [1] 430452 0
At the end of the intervention (i.e., two months after the start of Ramadan).
Secondary outcome [2] 431066 0
Impact on Religiosity.
Assessment method [2] 431066 0
Duke University Religious Index (DUREL). This will be collected through an online questionnaire.
Timepoint [2] 431066 0
Baseline, at the end of Ramadan, and at the end of intervention (i.e., 2 months after the start of Ramadan).
Secondary outcome [3] 431067 0
Nicotine dependence for cigarette smokers
Assessment method [3] 431067 0
The Fagerstrom Test for Nicotine Dependence (FTND). This will be collected through an online questionnaire.
Timepoint [3] 431067 0
Baelines, at the end of Ramadan, end of intervention (i.e., two months after the start of Ramadan), and three months after commencing Ramadan.
Secondary outcome [4] 431071 0
Nicotine Withdrawal
Assessment method [4] 431071 0
The revised long-version of the Wisconsin Smoking Withdrawal Scale (WSWS2-L). This will be collected through an online questionnaire.
Timepoint [4] 431071 0
At the end of Ramadan, at the end of intervention (i.e., two months after the start of Ramadan), and three months after commencing Ramadan.
Secondary outcome [5] 431072 0
Motivation to Stop Smoking
Assessment method [5] 431072 0
The Motivation to Stop Smoking (MTSS) scale. This will be collected through an online questionnaire.
Timepoint [5] 431072 0
Baseline, at the end of Ramadan, at the end of intervention (i.e., two months after the start of Ramadan), and three months after commencing Ramadan.
Secondary outcome [6] 431073 0
Saliva cotinine levels
Assessment method [6] 431073 0
Saliva cotinine level test. The test kits will be sent to participants' home addresses. Participants will do the test by themselves and email the research team a picture of the results.
Timepoint [6] 431073 0
Three months after the start of Ramadan.
Secondary outcome [7] 431074 0
Retention
Assessment method [7] 431074 0
Percent retention is measured by dividing the number of participants who were present at the end of treatment by the number of individuals who were enrolled and began the trial.
Timepoint [7] 431074 0
The end of intervention (i.e., two months after the start of Ramadan), and three months after commencing Ramadan.
Secondary outcome [8] 431173 0
Smoking cessation
Assessment method [8] 431173 0
7-day point-prevalence abstinence. This will be collected through an online questionnaire.
Timepoint [8] 431173 0
End of Ramadan and end of intervention (i.e., two months after the start of Ramadan).
Secondary outcome [9] 431189 0
Nicotine Dependence for waterpipe smokers.
Assessment method [9] 431189 0
The Lebanon Waterpipe Dependence Scale. This will be collected through an online questionnaire.
Timepoint [9] 431189 0
Baelines, at the end of Ramadan, end of intervention (i.e., two months after the start of Ramadan), and three months after commencing Ramadan.
Secondary outcome [10] 431617 0
Adherence to protocl
Assessment method [10] 431617 0
Self-report measures by sending weekly text messages asking participants if they read all. most, some, or none of the messages in the previous week. Participants must reply with the corresponding number (1=read all the messages, 2=read most of the messages, 3=read some, 4=read none). This will be collected through text messages,
Timepoint [10] 431617 0
Weekly throughout the intervention (i.e., two months) beginning one week after the start of Ramadan.

Eligibility
Key inclusion criteria
1) an adult aged 18 years or older, 2) self-identify as a Muslim, 3) currently smokes cigarettes, waterpipe, or both, 4) have a mobile phone capable of receiving and sending text messages, 5) willing to observe Ramadan, 6) willing to quit smoking during Ramadan, 7) can read basic English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants receiving any form of behavioural interventions/therapy and participants on medications to quit smoking.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation by computer with a 1:1 allocation ratio. Researchers have no influence on randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/02/2024
Actual
Date of last participant enrolment
Anticipated
8/03/2024
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 26067 0
New Zealand
State/province [1] 26067 0

Funding & Sponsors
Funding source category [1] 315532 0
University
Name [1] 315532 0
The University of Auckland
Country [1] 315532 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Country
New Zealand
Secondary sponsor category [1] 317617 0
None
Name [1] 317617 0
Country [1] 317617 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314432 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 314432 0
Ethics committee country [1] 314432 0
New Zealand
Date submitted for ethics approval [1] 314432 0
11/01/2024
Approval date [1] 314432 0
05/02/2024
Ethics approval number [1] 314432 0
2024 EXP 19458

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 131562 0
Mr Abdullah Kalantan
Address 131562 0
University of Auckland, School of Population Health, Building 507, 22 Park Avenue, Grafton, Auckland 1023
Country 131562 0
New Zealand
Phone 131562 0
+64 273393244
Fax 131562 0
Email 131562 0
akal440@aucklanduni.ac.nz
Contact person for public queries
Name 131563 0
Abdullah Kalantan
Address 131563 0
University of Auckland, School of Population Health, Building 507, 22 Park Avenue, Grafton, Auckland 1023
Country 131563 0
New Zealand
Phone 131563 0
+64 273393244
Fax 131563 0
Email 131563 0
akal440@aucklanduni.ac.nz
Contact person for scientific queries
Name 131564 0
Abdullah Kalantan
Address 131564 0
University of Auckland, School of Population Health, Building 507, 22 Park Avenue, Grafton, Auckland 1023
Country 131564 0
New Zealand
Phone 131564 0
+64 273393244
Fax 131564 0
Email 131564 0
akal440@aucklanduni.ac.nz

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.