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Clinical Trials/NCT03994445
NCT03994445
Unknown
N/A

Effectiveness of Mobile Phone-Based Intervention to Prevent Smoking Relapse Among Recent Smoking Quitters in Jazan Region: Randomized Control Trial.

Ibtihal Altalhi1 site in 1 country476 target enrollmentJuly 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Smoking Cessation
Sponsor
Ibtihal Altalhi
Enrollment
476
Locations
1
Primary Endpoint
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
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2019
End Date
April 30, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ibtihal Altalhi
Responsible Party
Sponsor Investigator
Principal Investigator

Ibtihal Altalhi

Dr

King Khalid University

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.

Outcomes

Primary Outcomes

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 Outcomes

  • Secondary outcomes included: (1) timing till self-reported relapse. (2) causes of relapse.(6 months following scheduled quit date)

Study Sites (1)

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