| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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) |
|
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Method of Generating Random Sequence
|
Not Applicable |
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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
|
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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 â€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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