An interventional study of Mobile Phone-Based Intervention in Smoking Cessation, sponsored by Ibtihal Altalhi. Status unknown at 1 site in Saudi Arabia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-21.
Sponsored by Ibtihal Altalhi · Not applicable, Interventional, and Prevention
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.
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.
350 studies on the registry are indexed under Smoking Cessation; 145 are open to participants now.
This study's planned enrollment of 476 is above the median of 150 across 326 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →This is the only study on the registry with Ibtihal Altalhi as lead sponsor.
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Exclusion Criteria:
Intervention group will be enrolled to the intervention program proposed to be (pharmacotherapy + counseling+ motivator phone messages).
Behavioral: Mobile Phone-Based Intervention
Control group will receive the standard treatment of the Ministry of the Health program (pharmacotherapy + counseling) only.
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 .
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.
Time frame: 6 months following scheduled quit date
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.
Time frame: 6 months following scheduled quit date
Start is estimated for Jul 2019; primary completion for Mar 2020, 8 months later.
Of 187 non-industry interventional studies with no phase under Smoking Cessation, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 8 months is below that.
Counting every sponsor, half of 190 studies reached it within 35 months; a quarter within 15 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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