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

NCT ID: NCT03994445

Last Updated: 2019-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

476 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

Intervention group will be enrolled to the intervention program proposed to be (pharmacotherapy + counseling+ motivator phone messages).

Group Type EXPERIMENTAL

Mobile Phone-Based Intervention

Intervention Type BEHAVIORAL

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 .

Control group

Control group will receive the standard treatment of the Ministry of the Health program (pharmacotherapy + counseling) only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 .

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ibtihal Altalhi

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ibtihal Altalhi

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohammed Mahfouz, ASSC PROF

Role: STUDY_DIRECTOR

University of Jazan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Smoking Cessation Clinic - Ministry of Health

Jizan, , Saudi Arabia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Saudi Arabia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ibtihal Altalhi, MBBS

Role: CONTACT

955540072443

Abdullah Alsabaani, ASST PROF

Role: CONTACT

966503082394

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ibtihal Altalhi, MBBS

Role: primary

966540072443

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SRP in recently quit smokers

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Take A Break - Rural
NCT05790486 RECRUITING NA
Disease Management for Smoking Cessation
NCT00440115 COMPLETED PHASE3