Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202407632045339 Date of Approval: 11/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Development, Implementation and Evaluation of MHealth WhatsApp Messages on Risk Communication on Motivation to Quit Cigarettes in a Cohort of Established Adult Poly Tobacco Users in Lagos State, Nigeria.
Official scientific title Development, Implementation and Evaluation of MHealth WhatsApp Messages on Risk Communication on Motivation to Quit Cigarettes in a Cohort of Established Adult Poly Tobacco Users in Lagos State, Nigeria.
Brief summary describing the background and objectives of the trial Tobacco use remains the leading cause of preventable disease, disability, and death globally. Tobacco kills more than eight million people each year. Cigarette smoking costs Nigeria ₦526.45 billion (approx. USD 1.7 billion) annually in direct treatment, which is equivalent to 0.36% of GDP and 9.63% of the country’s annual healthcare budget. Tobacco cessation is integral to global efforts to reduce the burden of tobacco-related illness. In Nigeria, Nicotine Replacement Therapy (NRTs) are inadequately available, not provided by health insurance, and are largely unaffordable. Moreover, the co-use of cigarettes, marijuana, and other drugs is common across the country. Aim: This study aims to investigate the role of risk communication/behavioral modification through WhatsApp Messages (using the transtheoretical model) on intent to quit, quit attempts, and successful quitting of cigarettes in a cohort of established adult poly-tobacco users in Lagos State.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial MHealth WhatsApp Messages on Risk Communication on Motivation to Quit Cigarettes
Anticipated trial start date 05/08/2024
Actual trial start date
Anticipated date of last follow up 31/05/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group MHealth WhatsApp Messages on Risk Communication on Motivation to Quit Cigarettes Participants will receive 168 texts over 12 weeks (2 texts per day). A reminder to participate in the telephone follow-up will also be sent at 1-, 3- and 6-month, making up a total of 171 messages Three months Participants in the intervention group will receive three months of individual, chat-based cessation support delivered through a mobile instant messaging application (WhatsApp). The design and content of the intervention will be based on the results of the focus group and validation done. These messages will cover generic information about the benefits of quitting, covering the 5 stages of the transtheoretical model on encouragement to quit and the use of smoking cessation services, with messages tailored to the stage of change the patient is in. Motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking cessation affects mood and general encouragement. Participants will receive 168 texts over 12 weeks (2 texts per day). A reminder to participate in the telephone follow-up will also be sent at 1-, 3- and 6-month, making up a total of 171 messages. 60
Control Group SMS WhatsApp messages One message at baseline, 1-, 3- and 6-month Three months Participants in the control group will only receive brief advice to quit at baseline (Ask, Warn, Advice) without offers of referral to smoking cessation services and WhatsApp SMS-based cessation support. They will receive four SMS messages delivered at 1-, 3- and 6-month as reminders for participating in telephone follow-up surveys. 60 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Eligibility criteria: To enroll in the program participants must be -18 years of age or older, -Have smoked at least 100 cigarettes in their lifetime -Have smoked ≥5 cigarette(s) per day in the past 3 months, verified by an exhaled carbon monoxide level of ≥8 ppm. - Have their own smartphones. - Able to use a WhatsApp messaging application installed on a cell phone and be familiar with sending and receiving WhatsApp messages. - Agree to accept health promotion information and communicate through mobile instant messaging to assist cessation, - Be able to understand messages written in English. - They should not already be enrolled in another text service to assist smoking cessation. - Be able and willing to give informed consent. Excluded from participation are those that: - Have mental or cognitive impairment or communication problems - Currently pregnant, assessed by a urine pregnancy test conducted on all premenopausal biologic females who have not had a hysterectomy, or planning to become pregnant in the next 2 months. - Screening positive for severe alcohol/marijuana use disorder, evidenced by a score ≥ 6 on the Marijuana Screening Inventory 51 and a score ≥ 20 on the Short Alcohol Dependence Data Questionnaire (SADD).52 -Prior serious adverse reaction to the nicotine patch, defined as any reaction that was life-threatening or required hospitalization. -Heart attack or chest pain within the past 2 weeks. -Inability to read a sentence written at a primary 4 grade level. Inability to provide informed consent, assessed with knowledge questions about the material presented during the informed consent process that individuals must correctly answer before providing informed consent to participate. - Simultaneous participation in another tobacco cessation study. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/07/2024 Lagos State University Teachng Hospital Health Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
1-5, Oba Akinjobi Way, GRA, Ikeja, Lagos State, Nigeria. Lagos 21266 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome: The primary outcome biochemically-verified 7-day point prevalence abstinence at 1-, 3- and 6-months. Participants reporting “no smoking” in the past 7 days will be coded as abstinent from cigarettes. At each follow-up assessment, participants reporting 7-day abstinence will have an expired CO and saliva cotinine test taken. Participants with CO < 8 ppm and a salivary cotinine level <11 ng/ml, will be considered confirmed nonsmokers. 7-day point prevalence abstinence at 1-, 3- and 6-months
Secondary Outcome • Reduction of cigarette consumption by 50 % or more (y/n) between baseline each follow-up will be calculated from the number of cigarettes smoked in the past 7 days at each time point. Changes in the average number of cigarettes per day relative to baseline, defined by self-report and repeatedly assessed at 1-, 3- and 6-months. • Tobacco quit attempt (y/n). A Follow-up Smoking Questionnaire will assess the presence and number of 24-hour quit attempts since the last assessment, used to calculate the presence of at least one quit attempt in the assessment period. • Readiness to quit tobacco will be assessed using the Stages of Change Questionnaire,44 categorizing participants into five stage categories at each time point (pre-contemplation, contemplation, preparation, action, and maintenance), and predictive of quit attempts and cessation.45 Outcome will be measured as proportion in action or maintenance stage of change at 1-, 3- and 6-month assessments. 1-, 3- and 6-months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos State University Teaching Hospital 1-5, Oba Akinjobi Way, GRA, Ikeja, Lagos 21266 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded 1-5, Oba Akinjobi Way, GRA, Ikeja, Lagos 21266 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self 1-5, Oba Akinjobi Way, GRA, Lagos 21266 Nigeria Self
COLLABORATORS
Name Street address City Postal code Country
Dr. Mohammad Ebrahimi Kalan Eastern Virginia Medical School, 825 Fairfax Ave, Norfolk, Virginia VA 23507, United States of America
Rime Jebai Boston University School of Public Health, 715 Albany St, Boston, Boston MA 02118 United States of America
Bteddini Dima University of Florida, College of Medicine, Department of Health Outcomes and Biomedical Informatic, 1889 Museum Rd, Suite 7000 Gainesville, Florida FL 32611 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Afolabi Oyapero afolabi.oyapero@lasucom.edu.ng +2348023018611 1-5, Oba Akinjobi Way, GRA, Ikeja,
City Postal code Country Position/Affiliation
Lagos 21266 Nigeria Senior Lecturer Lagos State University College of Medicine
Role Name Email Phone Street address
Scientific Enquiries Mohammad Ebrahimi Kalan KalanME@evms.edu +17574465049 825 Fairfax Ave, Norfolk,
City Postal code Country Position/Affiliation
Virginia VA 23507 United States of America Assistant Professor in Epidemiology at the School of Health Professions Eastern Virginia Medical School
Role Name Email Phone Street address
Public Enquiries Samson Kareem samkareem700@gmail.com +2348083938751 1-5 Oba akinjobi Way, GRA, Ikeja
City Postal code Country Position/Affiliation
Lagos 21266 Nigeria Dental Officer Lagos State University Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD Sharing Plan: The following outlines our plan to share individual participant data collected in this study. Data Sharing: Yes, we plan to share individual participant data (IPD). What Data Will Be Shared: De-identified individual participant data underlying the results reported in this article, including text, tables, figures, and appendices. Additional related documents including the study protocol, statistical analysis plan, and informed consent form. When Will Data Be Available: The data will be available beginning 12 months following publication of the primary results. Data will be available indefinitely. With Whom Will Data Be Shared: Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in their proposal. Proposals should be directed to [afolabi.oyapero@lasucom.edu.ng]. For What Types of Analyses: Data will be shared for analyses to achieve the aims outlined in the approved proposal. Ethical Considerations: The shared data will be de-identified to protect participant privacy. Data will be shared in compliance with relevant ethical guidelines and regulations. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months How to Access the Data: Researchers should provide a proposal describing their study aims and analysis plan. Proposals should be directed to [email/contact information]. To gain access, data requestors will need to sign a data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information