Effectiveness of Mobile Phone-Based Intervention to Prevent Smoking Relapse Among Recent Smoking Quitters
1 other identifier
interventional
476
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2019
CompletedFirst Posted
Study publicly available on registry
June 21, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedJune 21, 2019
June 1, 2019
9 months
June 12, 2019
June 20, 2019
Conditions
Outcome Measures
Primary Outcomes (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
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 Outcomes (1)
Secondary outcomes included: (1) timing till self-reported relapse. (2) causes of relapse.
6 months following scheduled quit date
Study Arms (2)
Intervention group
EXPERIMENTALIntervention group will be enrolled to the intervention program proposed to be (pharmacotherapy + counseling+ motivator phone messages).
Control group
NO INTERVENTIONControl group will receive the standard treatment of the Ministry of the Health program (pharmacotherapy + counseling) only.
Interventions
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 .
Eligibility Criteria
You may qualify if:
- Aged 18 years or older.
- Recent quitters (24 hours smoking abstinence)
- Willing to provide informed consent to participate in the study.
You may not qualify if:
- Those suffering any physical or mental disorders.
- Illiterate people.
- Pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ibtihal Altalhilead
Study Sites (1)
Smoking Cessation Clinic - Ministry of Health
Jizan, Saudi Arabia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mohammed Mahfouz, ASSC PROF
University of Jazan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
June 12, 2019
First Posted
June 21, 2019
Study Start
July 1, 2019
Primary Completion
March 31, 2020
Study Completion
April 30, 2020
Last Updated
June 21, 2019
Record last verified: 2019-06