Clinical trial NCT06766227: Smoking Cessation App. in Arabic
Official title: Developing a Smoking Cessation Mobile App. in Arabic: A Pilot Randomized Trial for Efficacy.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: mHealth, Smoking, Cigarette, Behavioral intervention, low-middle income countries
Lead sponsor: Yarmouk University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Successful quit attempt
timeFrame: 3 months
Secondary outcomes:
measure: Reduction in Smoking Rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Yarmouk University
Study officials:
References: