Smoking CessationNCT03994445
Effectiveness of Mobile Phone-Based Intervention to Prevent Smoking Relapse Among Recent Smoking Quitters
A study testing Mobile Phone-Based Intervention in people with Smoking Cessation, run by Ibtihal Altalhi at 1 site in Saudi Arabia.
Trial summary
Main Objective The main objective of the study is to investigate the effectiveness of a mobile phone-based intervention in reducing relapse ate among recent quitters who are attending the smoking cessation program in Jazan. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Mobile Phone-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 476 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jul 2019to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older.
- Recent quitters (24 hours smoking abstinence)
- Willing to provide informed consent to participate in the study.
Who cannot join
- Those suffering any physical or mental disorders.
- Illiterate people.
- Pregnant.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Smoking Cessation Clinic - Ministry of Health
Jizan
Ibtihal Altalhi, MBBS, 966540072443, ebtihal2012@hotmail.com
About this study
Official title: Effectiveness of Mobile Phone-Based Intervention to Prevent Smoking Relapse Among Recent Smoking Quitters in Jazan Region: Randomized Control Trial.
Main Objective The main objective of the study is to investigate the effectiveness of a mobile phone-based intervention in reducing relapse ate among recent quitters who are attending the smoking cessation program in Jazan.
Besides this, the study will achieve the following objective:
To identify the timing and different factors associated with relapse process among recent quitters during first 6 months of quitting.
Read the detailed description
Background:
Smoking remains a major public health problem and an important cause of morbidity and mortality worldwide. Although the effectiveness of behavior support and medical treatment, many of those who quit smoking subsequently relapse to smoke.
Objective:
The primary aim of this study will be to determine the effectiveness of the mobile phone-based intervention to prevent relapse among recent smoking quitters. Also, the study aims to identify the different factors associated with relapse among recent quitters during the first 6 months of quitting.
Design and Methods:
A parallel two-armed Randomized Controlled Trial (RCT) to assess the effectiveness of a mobile phone-based intervention for smoking cessation on achieving long term abstinence, will be conducted among volunteers. Participants will be recruited from those attended smoking cessation program in Southern Alrawdha clinic, Southern Abo Arish clinic, Sabia clinic and Aldhabia clinic.
Primary outcome:
The difference in relapsing rate among recent quitters, which may subsequently contribute in to a reduction in smoking rates.
Trail Implications for public Health:
The result of this study will provide evidence for effectiveness of the mobile phone-based intervention versus standard treatment to reduce smoking relapse rate. If proven, it will be a cost-saving intervention by reducing repeat use of the smoking cessation clinic services and by reducing use of healthcare services for smoking-related illness.
- Conditions
- Smoking Cessation
- Being tested
- Mobile Phone-Based Intervention
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Phone-Based InterventionBehavioural
We propose our intervention based on social cognitive behavior theories and the stages of the change model.
The program will be carried out using the word "Mettle", it will help ex-smokers stay off cigarettes through advices generated to promote the health from religious concepts and culture perspectives .
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group will be enrolled to the intervention program proposed to be (pharmacotherapy + counseling+ motivator phone messages). Receives: Behavioral: Mobile Phone-Based Intervention |
| Control group | No intervention | Control group will receive the standard treatment of the Ministry of the Health program (pharmacotherapy + counseling) only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study outcome will be the difference at 6 months relapse rate between the two arms, relapse rate will be identified as a return to continuous smoking even a puff after obtaining 24 hours of abstinence
Relapse rates at the end of the 3rd and 6th month of follow-up in the intervention and control groups.
Measured: 6 months following scheduled quit date
Secondary outcomes (1)
Secondary outcomes included: (1) timing till self-reported relapse. (2) causes of relapse.
Participants will be asked core smoking status questions, including whether they have smoked any cigarettes or used other tobacco products, even a puff, in the last 30 days, 7-day point prevalence abstinence, the exact day of each smoking relapse episode and the cause of relapse.
Measured: 6 months following scheduled quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start1 Jul 2019 (estimated)
- Primary completion31 Mar 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 476 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ibtihal Altalhi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ibtihal Altalhi, King Khalid University
- Investigators
- Mohammed Mahfouz, ASSC PROF, Study director, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994445
- Sponsor's protocol ID
- SRP in recently quit smokers
- Status last verified
- Jun 2019
- First submitted
- 12 Jun 2019
- Last updated
- 21 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mobile Phone-Based Intervention to Prevent Smoking Relapse Among Recent Smoking Quitters in Jazan Region: Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT03994445
- Acronym / sponsor ID
- SRP in recently quit smokers
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 476 participants (estimated)
- Lead sponsor
- Ibtihal AltalhiUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Main Objective The main objective of the study is to investigate the effectiveness of a mobile phone-based intervention in reducing relapse ate among recent quitters who are attending the smoking cessation program in Jazan.
Besides this, the study will achieve the following objective:
To identify the timing and different factors associated with relapse process among recent quitters during first 6 months of quitting.
Detailed description
Background:
Smoking remains a major public health problem and an important cause of morbidity and mortality worldwide. Although the effectiveness of behavior support and medical treatment, many of those who quit smoking subsequently relapse to smoke.
Objective:
The primary aim of this study will be to determine the effectiveness of the mobile phone-based intervention to prevent relapse among recent smoking quitters. Also, the study aims to identify the different factors associated with relapse among recent quitters during the first 6 months of quitting.
Design and Methods:
A parallel two-armed Randomized Controlled Trial (RCT) to assess the effectiveness of a mobile phone-based intervention for smoking cessation on achieving long term abstinence, will be conducted among volunteers. Participants will be recruited from those attended smoking cessation program in Southern Alrawdha clinic, Southern Abo Arish clinic, Sabia clinic and Aldhabia clinic.
Primary outcome:
The difference in relapsing rate among recent quitters, which may subsequently contribute in to a reduction in smoking rates.
Trail Implications for public Health:
The result of this study will provide evidence for effectiveness of the mobile phone-based intervention versus standard treatment to reduce smoking relapse rate. If proven, it will be a cost-saving intervention by reducing repeat use of the smoking cessation clinic services and by reducing use of healthcare services for smoking-related illness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Mobile Phone-Based InterventionIntervention group will be enrolled to the intervention program proposed to be (pharmacotherapy + counseling+ motivator phone messages). |
| Control group | No intervention | –Control group will receive the standard treatment of the Ministry of the Health program (pharmacotherapy + counseling) only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older.
- Recent quitters (24 hours smoking abstinence)
- Willing to provide informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Those suffering any physical or mental disorders.
- Illiterate people.
- Pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Phone-Based InterventionWe propose our intervention based on social cognitive behavior theories and the stages of the change model. The program will be carried out using the word "Mettle", it will help ex-smokers stay off cigarettes through advices generated to promote the health from religious concepts and culture perspectives . | Behavioural | Intervention group |
Primary outcome
The primary study outcome will be the difference at 6 months relapse rate between the two arms, relapse rate will be identified as a return to continuous smoking even a puff after obtaining 24 hours of abstinence
Time frame: 6 months following scheduled quit date
Relapse rates at the end of the 3rd and 6th month of follow-up in the intervention and control groups.
1 secondary outcome
Secondary outcomes included: (1) timing till self-reported relapse. (2) causes of relapse.
Time frame: 6 months following scheduled quit date
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Mahfouz, ASSC PROF study director
University of Jazan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Phone-Based Intervention in people with Smoking Cessation, run by Ibtihal Altalhi at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ibtihal Altalhi, MBBS (955540072443, ebtihal2012@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary study outcome will be the difference at 6 months relapse rate between the two arms, relapse rate will be identified as a return to continuous smoking even a puff after obtaining 24 hours of abstinence (time frame: 6 months following scheduled quit date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.