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

Not Applicable
Conditions
Smoking Cessation
Interventions
Behavioral: Mobile Phone-Based Intervention
Registration Number
NCT03994445
Lead Sponsor
Ibtihal Altalhi
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
476
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention groupMobile Phone-Based InterventionIntervention group will be enrolled to the intervention program proposed to be (pharmacotherapy + counseling+ motivator phone messages).
Primary Outcome Measures
NameTimeMethod
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 abstinence6 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
NameTimeMethod
Secondary outcomes included: (1) timing till self-reported relapse. (2) causes of relapse.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.

Trial Locations

Locations (1)

Smoking Cessation Clinic - Ministry of Health

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Jazan, Saudi Arabia

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