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Effectiveness of Mobile Phone-Based Intervention to Prevent Smoking Relapse Among Recent Smoking Quitters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994445
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ibtihal Altalhi, King Khalid University

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.


Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Mobile Phone-Based Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 476 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effectiveness of Mobile Phone-Based Intervention to Prevent Smoking Relapse Among Recent Smoking Quitters in Jazan Region: Randomized Control Trial.
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Intervention group will be enrolled to the intervention program proposed to be (pharmacotherapy + counseling+ motivator phone messages).
Behavioral: Mobile Phone-Based Intervention

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 .


No Intervention: Control group
Control group will receive the standard treatment of the Ministry of the Health program (pharmacotherapy + counseling) only.



Primary Outcome Measures :
  1. 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 [ Time Frame: 6 months following scheduled quit date ]
    Relapse rates at the end of the 3rd and 6th month of follow-up in the intervention and control groups.


Secondary Outcome Measures :
  1. Secondary outcomes included: (1) timing till self-reported relapse. (2) causes of relapse. [ Time Frame: 6 months following scheduled quit date ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994445


Contacts
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Contact: Ibtihal Altalhi, MBBS 955540072443 ebtihal2012@hotmail.com
Contact: Abdullah Alsabaani, ASST PROF 966503082394 dr.alsabaani@hotmail.com

Locations
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Saudi Arabia
Smoking Cessation Clinic - Ministry of Health
Jazan, Saudi Arabia
Contact: Ibtihal Altalhi, MBBS    966540072443    ebtihal2012@hotmail.com   
Sponsors and Collaborators
Ibtihal Altalhi
Investigators
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Study Director: Mohammed Mahfouz, ASSC PROF Jazan University
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Responsible Party: Ibtihal Altalhi, Dr, King Khalid University
ClinicalTrials.gov Identifier: NCT03994445    
Other Study ID Numbers: SRP in recently quit smokers
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes