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

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

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.

Study Overview

• Status: Unknown
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Mobile Phone-Based Intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 476
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jazan, Saudi Arabia
    • Smoking Cessation Clinic - Ministry of Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months following scheduled quit date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months following scheduled quit date

Collaborators and Investigators

• Sponsor: Ibtihal Altalhi
• Investigators: Study Director: Mohammed Mahfouz, ASSC PROF, Jazan University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2019
• Primary Completion (ANTICIPATED): March 31, 2020
• Study Completion (ANTICIPATED): April 30, 2020

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (ACTUAL): June 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2019
• Last Update Submitted That Met QC Criteria: June 20, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: SRP in recently quit smokers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No