Clinical trial NCT03994445: Effectiveness of Mobile Phone-Based Intervention to Prevent Smoking Relapse Among Recent Smoking Quitters
Official title: Effectiveness of Mobile Phone-Based Intervention to Prevent Smoking Relapse Among Recent Smoking Quitters in Jazan Region: Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: King Khalid University
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older.
* Recent quitters (24 hours smoking abstinence)
* Willing to provide informed consent to participate in the study.

Exclusion Criteria:

* Those suffering any physical or mental disorders.
* Illiterate people.
* Pregnant.

Primary outcomes:
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
timeFrame: 6 months following scheduled quit date
Secondary outcomes:
measure: Secondary outcomes included: (1) timing till self-reported relapse. (2) causes of relapse.
timeFrame: 6 months following scheduled quit date
Other outcomes:
Locations:
city: Jazan
country: Saudi Arabia
facility: Smoking Cessation Clinic - Ministry of Health
Study officials:
affiliation: University of Jazan
name: Mohammed Mahfouz, ASSC PROF
role: STUDY_DIRECTOR
References: