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CTRI Number  CTRI/2024/03/064585 [Registered on: 21/03/2024] Trial Registered Prospectively
Last Modified On: 20/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Quit Smoking with FreshStart: Helping you stop the habit of tobacco smoking using a new smartphone application 
Scientific Title of Study   Exploring the Feasibility,Acceptability and Usage patterns of a Smoking Cessation Smartphone App FreshStart among 18-50 years old individuals A Pilot Study Quasi experimental  
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shweta Rai 
Designation  Postgraduate Master of Public Health Student 
Affiliation  Indian Institute of public health-delhi 
Address  Indian Institute of Public Health-Delhi,KIIT college of Engineering 3rd floor,Sohna Road,Bhondsi,Near Maruti Kunj Gurugram-Haryana-122102 India

East
DELHI
110095
India 
Phone  8853762468  
Fax    
Email  Shwetarai789@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saurav Basu 
Designation  Assistant Professor-IIPH Delhi 
Affiliation  Indian Institute of Public Health - Delhi 
Address  Indian Institute of Public Health - Delhi,KIIT College of Engineering 3rd floor,Sohna Road,Bhondsi,Near Maruti Kunj Gurugram-Haryana-122102 India

Gurgaon
HARYANA
122102
India 
Phone  7042073761  
Fax    
Email  saurav.basu@iiphd.org  
 
Details of Contact Person
Public Query
 
Name  Shweta Rai 
Designation  Postgraduate Masters of Public health 
Affiliation  Indian institute of public health-Delhi 
Address  Vivek Vihar,New Delhi
Indian Institute of Public Health-delhi KIIT College of Engineering 3rd floor,Sohna road,Bhondsi,Near Maruti kunj Gurugram-Haryana-122102 India
New Delhi
DELHI
110095
India 
Phone  8853762468  
Fax    
Email  Shwetarai789@gmail.com  
 
Source of Monetary or Material Support  
Indian institute Of public health Delhi,KIIT College of Engineering,3rd floor,Sohna Road,Bhondsi near maruti kunj,Gurugram Haryana,India,PIN-122102 
 
Primary Sponsor  
Name  Shweta Rai 
Address  IIPH Delhi,KIIT College of Engineering,3rd floor,Sohna Road,Bhondsi Near Mruti Kunj,Gurugram Haryana,India,PIN-122102 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shweta Rai  Indian Institute Of Public Health Delhi  Faculty Room - 01, Indian Institute Of Public Health Delhi, KIIT Engineering College, 3rd Floor, KIIT Rd, Bhondsi,Haryana 122102
Gurgaon
HARYANA 
8853762468

Shwetarai789@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indian Institute of Public Health Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Tobacco smoking current users 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  FreshStart android smartphone mobile application (English language)  The application includes sections featuring youtube videos covering topics such as the adverse effects of smoking,health tips for quitting,challenges in the quitting process,strategies to overcome the cravings.The integration allows participants to easily engage with educational content and inspiration from others who have overcome the challenges of smoking cessation.The study incorporates informative sections including FYIs,challenges and health tips,direct links for national tobacco quitline designated to support participants in enhancing their health and aiding cessation efforts.For the engagement of the participants,the participants who accept the challenges will receive rewards,fostering motivation in the cessation program.An integrated engagement tracking system is implemented to monitor participants interections within the intervention,including the number of times messages are read and video content is viewed.The comprehensive tracking mechanism ensures accurate measurement and analysis of user engagement throughout the intervention period. The duration of the intervention will be 1 month.  
Comparator Agent  None  None 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. The study population will consist of people of age range 18-50 years who are willing to use digital mobile applications for smoking cessation.
Participants who have been smoking more than six 2. months. 3. Can read and write in the English language
 
 
ExclusionCriteria 
Details  1.Participants who are addicted to any drug
2.Participants who are addicted to alcohol (who drink alcohol more than three days per week) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Change in the tobacco smoking patterns (frequency) in the participants
2. Change in the intention to quit tobacco 
baseline: 0 days
endline: 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Perceived satisfaction with the FreshStart application (endline)
2. Engagement with the FreshStart application (frequency of utilization of application features including videos and texts) 
Baseline: 0 day
endline: 30 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   31/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Aim of the study: To explore the feasibility, acceptability and usage patterns of a smoking cessation smartphone app(Fresh Start) among 18-50 years old individuals who can read and write in the English language.

 

Objectives:

1.Conduct a pilot study to explore the feasibility, acceptability , and usage patterns of the smoking cessation smartphone app ”Fresh Start” among individuals aged 18-50 seeking help for quitting smoking.

2.Evaluate the effectiveness of the app in promoting behavioural changes related to smoking cessation reductions in cigarette consumption

3.Assess user satisfaction and usability of the Fresh Start app among participants 

4.Utilize the pilot study to address challenges and inform the design of future larger scale studies on smoking cessation interventions using mobile applications.

 

Methods-

Study sites and population-

The recruitment of participants for this study will involve targeted outreach on prominent online platforms, notably Instagram, Facebook, and WhatsApp. Individuals actively seeking assistance of age range 18-50 years for smoking cessation via these platforms will be encouraged to engage in the study by downloading a designated mobile application designed to aid in smoking cessation. Enrolled participants will receive guidance on how to navigate and utilize the application to access its resources and support features aimed at facilitating smoking cessation.

Sampling method & sample size- The study will employ snowball-sampling methodology to achieve a minimum sample size of 50 participants, with the potential to expand beyond this threshold.

Intervention: In the study, participants will be requested to install a dedicated mobile application designed specifically for smoking cessation purposes, tailored for Android users. Upon downloading the application from the link or by scanning the QR code, individuals will be prompted to sign in, where an informed consent process will be integrated into the initial user interface. Upon accessing the application and consenting to participate in the study, participants will be directed to complete a baseline questionnaire. This questionnaire will encompass various demographic details such as age, city of residence, gender, alongside smoking-related specifics including duration, frequency, previous attempts or interventions for smoking cessation, and other pertinent factors. Post successful submission of responses participants will then be enrolled to receive daily motivational messages via the application. These daily motivational messages will serve as supportive and informative content aimed at aiding smoking cessation efforts. The messages will be delivered consistently to the participants as part of the intervention strategy, providing encouragement, tips, reminders, and motivational content to support their smoking cessation journey.

Informed consent- Upon downloading the designated mobile application from the link or by scanning the QR code from the flyer, participants will encounter a displayed Participant Information Sheet (PIS) and consent form on their device screens. They will be prompted to thoroughly read through the provided information and subsequently confirm their voluntary participation in the study by providing explicit consent through the application interface.

Data management- The data collected will be stored, managed, and analysed in a password-secured computer ensuring the participant’s confidentiality

Ascertaining outcomes- Application is intended to obtain baseline characteristics (gender, age, nicotine dependence, frequency, and previous use of cessation intervention method, place and frequency of intervention, success of cessation intervention). Other outcomes related to effectiveness of application will be the frequency and behavioural change towards smoking habit, substituted behaviour, future intention and satisfaction level post using the application.

 


 
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