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

Primary Purpose

Smoking Cessation

Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Mobile Phone-Based Intervention
Sponsored by
Ibtihal Altalhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking Cessation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Smoking Cessation Clinic - Ministry of Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 12, 2019
Last Updated
June 20, 2019
Sponsor
Ibtihal Altalhi
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1. Study Identification

Unique Protocol Identification Number
NCT03994445
Brief Title
Effectiveness of Mobile Phone-Based Intervention to Prevent Smoking Relapse Among Recent Smoking Quitters
Official Title
Effectiveness of Mobile Phone-Based Intervention to Prevent Smoking Relapse Among Recent Smoking Quitters in Jazan Region: Randomized Control Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ibtihal Altalhi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
476 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intervention group will be enrolled to the intervention program proposed to be (pharmacotherapy + counseling+ motivator phone messages).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group will receive the standard treatment of the Ministry of the Health program (pharmacotherapy + counseling) only.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Phone-Based Intervention
Intervention Description
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 .
Primary Outcome Measure Information:
Title
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
Description
Relapse rates at the end of the 3rd and 6th month of follow-up in the intervention and control groups.
Time Frame
6 months following scheduled quit date
Secondary Outcome Measure Information:
Title
Secondary outcomes included: (1) timing till self-reported relapse. (2) causes of relapse.
Description
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.
Time Frame
6 months following scheduled quit date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ibtihal Altalhi, MBBS
Phone
955540072443
Email
ebtihal2012@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abdullah Alsabaani, ASST PROF
Phone
966503082394
Email
dr.alsabaani@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Mahfouz, ASSC PROF
Organizational Affiliation
Jazan University
Official's Role
Study Director
Facility Information:
Facility Name
Smoking Cessation Clinic - Ministry of Health
City
Jazan
Country
Saudi Arabia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibtihal Altalhi, MBBS
Phone
966540072443
Email
ebtihal2012@hotmail.com

12. IPD Sharing Statement

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

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