Smoking CessationiEndSmokinNCT06766227
Smoking Cessation App. in Arabic
A study testing iEndSmokin App and Educational Session in people with Smoking Cessation, run by Yarmouk University at 1 site in Jordan.
Trial summary
Smoking remains a significant global health challenge, causing over 8 million deaths annually, with the burden predominantly in low- and middle-income countries. Jordan experiences some of the highest smoking rates worldwide, contributing to substantial health risks and premature mortality. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- iEndSmokin App and Educational Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jun 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Study participants will be students attending Yarmouk University recruited through emails and flyers distributed to all offer the University's Faculties. Participation will be on a voluntary base. Only students who fulfill the following criteria will be invited to participate in the study. The inclusion criteria are: 1) a Yarmouk University student, 2) aged 18 years old and above, 3) smoked ≥5 cigarettes a day for the past year (25), 4) have a smartphone (iOS or Android), and 4) express willingness to quit smoking.
Who cannot join
- The exclusion criteria are: 1) non-Arabic speaker, 2) have certain conditions that interfere with the intervention like blindness or deafness, 3) have clinical depression or mental illness, 4) smoke only hookah, or 5) participate in another smoking cessation program.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site
Yarmouk University
Irbid, 21163
Ola Soudah, PhD, 00962799602620, ola.soudah@yu.edu.jo
About this study
Official title: Developing a Smoking Cessation Mobile App. in Arabic: A Pilot Randomized Trial for Efficacy.
Smoking remains a significant global health challenge, causing over 8 million deaths annually, with the burden predominantly in low- and middle-income countries. Jordan experiences some of the highest smoking rates worldwide, contributing to substantial health risks and premature mortality. Despite the prevalence of mobile health (mHealth) applications for smoking cessation, few have supported the Arabic language and none have been evaluated for their efficacy. Our main goal is to develop a culture-sensitive mHealth app in Arabic for smoking cessation and test its efficacy.
Read the detailed description
Jordan's smoking rates remain among the highest globally despite various initiatives such as smoke-free policies, advertising bans, increased tobacco taxes, and health promotion programs. Mobile health (mHealth) apps have proven effective in delivering education, monitoring health, supporting diagnoses, and acting as therapeutic platforms, overcoming barriers like location, scheduling, and cost. In Jordan, 90% of the population owns smartphones. High-quality apps typically include features like education, goal-setting, progress tracking, skill-building exercises, and community support. Smoking cessation apps' success rates reached up to 27%, where abstinence rates range from 11% to 40.9% within six months.
Treatment guidelines for smoking cessation and/or Psychological therapeutic models such as cognitive behavior therapy (CBT), acceptance commitment therapy (ACT), and mindfulness were infrequently or partially addressed in most Apps. CBT-based smoking-cessation apps are suggested to be more effective. However, adherence to evidence-based guidelines in these apps is low including most commercially available apps. Long-term studies to evaluate App effectiveness and sustainability are scarce. Smoking cessation Apps studies from low-middle-income countries had poor quality, including small sample size, weak designs, and methodological problems, and can't be generalizable across different geographic areas. There is a limited number of smoking cessation Apps in Arabic with no studies testing their efficacy. The Arabic language is widespread, there are about 360.2 people Arabic is their native language encompassing 22 countries. Therefore, the smoking cessation App in Arabic shows an exciting promise for lowering smoking rates at a low cost and convenient setting and thereby preventing tobacco-related premature deaths.
- Conditions
- Smoking Cessation
- Being tested
- iEndSmokin App, Educational Session
- Keywords
- mHealth, Smoking, Cigarette, Behavioral intervention, low-middle income countries
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iEndSmokin AppBehavioural
Mobile Health App that includes educational material and psychological programs based on CBT.
Educational SessionBehavioural
It will include lectures and distribution of educational material about smoking health risks and strategies to quit.
| Study group | Role | What they receive |
|---|---|---|
| App Group | Experimental | The smoking cessation app will be downloaded and explained to all intervention arm participants after a 2-week run-in period and baseline assessment completion. The smoking cessation app will help smokers set a plan, know how to stop either immediately or progressively, monitor their smoking status and progression, give them tips to overcome cravings, prevent relapses, and aid their mood changes during the cessation trial. The app will provide electronic content, tips, and exercises in written or video-recorded forms. All app content will be evidence-based; based on clinical guidelines and interventions proven in medical literature to be effective. Clinical guidelines used are the "Treating Tobacco Use and Dependence ("2008 update"), and the WHO guidelines. Psychological exercises will be based on CBT which has been shown to reduce smoking rate. Receives: Behavioral: iEndSmokin App |
| Education Group | Active comparator | Three sessions will be provided to the control group one each week for the first month of the study. The first session will take place after a 2-week run-in period following the randomization. All sessions will take place at the Yarmouk University campus or virtually via Zoom in Arabic by a trained research assistant for smoking cessation counseling. The sessions will be educational sessions about smoking health risks, why you should stop, how to stop, and skills and strategies for dealing with withdrawal symptoms. Receives: Behavioral: Educational Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful quit attempt
A successful smoking quit event is defined as follows: Participants reported 30 days' abstinence from smoking and all nicotine/tobacco products (Hookah, e-cigarettes, HEETS, cigars, gums …etc.), and very low level of nicotine level (account for second-hand smoking levels) will be considered translated into 30-point abstinence prevalence, and the normal nicotine level in saliva or blood level. Smoking status was the self-reported response to the question "When was the last time you smoked or even tried a cigarette?" Responses choices were "Earlier today", "24 hours ago", "2-7 days ago", "8-30 days ago", and "Over 30 days ago". Salivary or blood Cotinine level test is sensitive to nicotine level for 48-72 hrs. and the samples can be stored for up to three months without jeopardizing the validity of the test
Measured: 3 months
Secondary outcomes (1)
Reduction in Smoking Rate
7-day point prevalence abstinence outcome or decrease in daily cigarettes use
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yarmouk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Ali Soudah, Yarmouk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766227
- Sponsor's protocol ID
- 23-2023
- Acronym
- iEndSmokin
- Status last verified
- Jan 2025
- First submitted
- 5 Jan 2025
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Soudah O, Aldalal'ah M, Alsabbah A, Khasawneh H, Khayyat O, Klaib AF, Alrefai S, Megdadi M. Developing and testing a smoking cessation app in Arabic language: A pilot randomized trial study protocol. Digit Health. 2025 Sep 12;11:20552076251378436. doi: 10.1177/20552076251378436. eCollection 2025 Jan-Dec.
PubMed 40949668
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Smoking Cessation Mobile App. in Arabic: A Pilot Randomized Trial for Efficacy.
- ClinicalTrials.gov ID
- NCT06766227
- Acronym / sponsor ID
- iEndSmokin / 23-2023
- Conditions
- Smoking Cessation
- Keywords
- mHealth, Smoking, Cigarette, Behavioral intervention, low-middle income countries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yarmouk UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 Jan 2025 (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.
Smoking remains a significant global health challenge, causing over 8 million deaths annually, with the burden predominantly in low- and middle-income countries. Jordan experiences some of the highest smoking rates worldwide, contributing to substantial health risks and premature mortality. Despite the prevalence of mobile health (mHealth) applications for smoking cessation, few have supported the Arabic language and none have been evaluated for their efficacy. Our main goal is to develop a culture-sensitive mHealth app in Arabic for smoking cessation and test its efficacy.
Detailed description
Jordan's smoking rates remain among the highest globally despite various initiatives such as smoke-free policies, advertising bans, increased tobacco taxes, and health promotion programs. Mobile health (mHealth) apps have proven effective in delivering education, monitoring health, supporting diagnoses, and acting as therapeutic platforms, overcoming barriers like location, scheduling, and cost. In Jordan, 90% of the population owns smartphones. High-quality apps typically include features like education, goal-setting, progress tracking, skill-building exercises, and community support. Smoking cessation apps' success rates reached up to 27%, where abstinence rates range from 11% to 40.9% within six months.
Treatment guidelines for smoking cessation and/or Psychological therapeutic models such as cognitive behavior therapy (CBT), acceptance commitment therapy (ACT), and mindfulness were infrequently or partially addressed in most Apps. CBT-based smoking-cessation apps are suggested to be more effective. However, adherence to evidence-based guidelines in these apps is low including most commercially available apps. Long-term studies to evaluate App effectiveness and sustainability are scarce. Smoking cessation Apps studies from low-middle-income countries had poor quality, including small sample size, weak designs, and methodological problems, and can't be generalizable across different geographic areas. There is a limited number of smoking cessation Apps in Arabic with no studies testing their efficacy. The Arabic language is widespread, there are about 360.2 people Arabic is their native language encompassing 22 countries. Therefore, the smoking cessation App in Arabic shows an exciting promise for lowering smoking rates at a low cost and convenient setting and thereby preventing tobacco-related premature deaths.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel
| Arm | Type | Receives |
|---|---|---|
| App Group | Experimental | Behavioral: iEndSmokin AppThe smoking cessation app will be downloaded and explained to all intervention arm participants after a 2-week run-in period and baseline assessment completion. The smoking cessation app will help smokers set a plan, know how to stop either immediately or progressively, monitor their smoking status and progression, give them tips to overcome cravings, prevent relapses, and aid their mood changes during the cessation trial. The app will provide electronic content, tips, and exercises in written or video-recorded forms. All app content will be evidence-based; based on clinical guidelines and interventions proven in medical literature to be effective. Clinical guidelines used are the "Treating Tobacco Use and Dependence ("2008 update"), and the WHO guidelines. Psychological exercises will be based on CBT which has been shown to reduce smoking rate. |
| Education Group | Active comparator | Behavioral: Educational SessionThree sessions will be provided to the control group one each week for the first month of the study. The first session will take place after a 2-week run-in period following the randomization. All sessions will take place at the Yarmouk University campus or virtually via Zoom in Arabic by a trained research assistant for smoking cessation counseling. The sessions will be educational sessions about smoking health risks, why you should stop, how to stop, and skills and strategies for dealing with withdrawal symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Study participants will be students attending Yarmouk University recruited through emails and flyers distributed to all offer the University's Faculties. Participation will be on a voluntary base. Only students who fulfill the following criteria will be invited to participate in the study. The inclusion criteria are: 1) a Yarmouk University student, 2) aged 18 years old and above, 3) smoked ≥5 cigarettes a day for the past year (25), 4) have a smartphone (iOS or Android), and 4) express willingness to quit smoking.
Key exclusion criteria (1 listed)
- The exclusion criteria are: 1) non-Arabic speaker, 2) have certain conditions that interfere with the intervention like blindness or deafness, 3) have clinical depression or mental illness, 4) smoke only hookah, or 5) participate in another smoking cessation program.
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 |
|---|---|---|
| iEndSmokin AppMobile Health App that includes educational material and psychological programs based on CBT. | Behavioural | App Group |
| Educational SessionIt will include lectures and distribution of educational material about smoking health risks and strategies to quit. | Behavioural | Education Group |
Primary outcome
Successful quit attempt
Time frame: 3 months
A successful smoking quit event is defined as follows: Participants reported 30 days' abstinence from smoking and all nicotine/tobacco products (Hookah, e-cigarettes, HEETS, cigars, gums …etc.), and very low level of nicotine level (account for second-hand smoking levels) will be considered translated into 30-point abstinence prevalence, and the normal nicotine level in saliva or blood level. Smoking status was the self-reported response to the question "When was the last time you smoked or even tried a cigarette?" Responses choices were "Earlier today", "24 hours ago", "2-7 days ago", "8-30 days ago", and "Over 30 days ago". Salivary or blood Cotinine level test is sensitive to nicotine level for 48-72 hrs. and the samples can be stored for up to three months without jeopardizing the validity of the test
1 secondary outcome
Reduction in Smoking Rate
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Derived from this study: PubMed 40949668Soudah O, Aldalal'ah M, Alsabbah A, Khasawneh H, Khayyat O, Klaib AF, Alrefai S, Megdadi M. Developing and testing a smoking cessation app in Arabic language: A pilot randomized trial study protocol. Digit Health. 2025 Sep 12;11:20552076251378436. doi: 10.1177/20552076251378436. eCollection 2025 Jan-Dec.
- Individual participant dataSharing planned: Undecided
Related trials for Smoking Cessation
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program
Focus of the Study is Smoking Cessation and Prevention, Smoking Prevention
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
Recruiting
Therapeutic Contact Intensity in a Psychological Smoking Cessation Intervention With an App
Smoking Behaviors
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iEndSmokin App and Educational Session in people with Smoking Cessation, run by Yarmouk University at 1 site in Jordan.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 9 Jan 2025. 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 Jordan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful quit attempt (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06766227, which also lists 1 linked publication.
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 9 Jan 2025.