Smoking Cessation App. in Arabic

NCT06766227 | Not Yet Recruiting

• 1 other identifier: 23-2023
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

mHealth, Smoking, Cigarette, Behavioral intervention, low-middle income countries

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (1)

• Reduction in Smoking Rate

  3 months

Study Arms (2)

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.

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.

Behavioral: Educational Session

Interventions

iEndSmokin App BEHAVIORAL

Mobile Health App that includes educational material and psychological programs based on CBT.

App Group

Educational Session BEHAVIORAL

It will include lectures and distribution of educational material about smoking health risks and strategies to quit.

Education Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Yarmouk University: lead

Study Sites (1)

Yarmouk University

Irbid, 21163, Jordan

Location

Related Publications (1)

• 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.

  PMID: 40949668 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Parallel

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 9, 2025
• Study Start: June 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

JO (1)