Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05732220
Other study ID # 202111159206
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 18, 2023
Est. completion date October 31, 2024

Study information

Verified date November 2023
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This pilot trial aims to examine the feasibility, acceptability, and preliminary effectiveness of EMA-based peer counseling for youth smokers.


Description:

Most smokers begin smoking during adolescence and early adulthood, a crucial period to prevent initiation and continuation of smoking. However, many proven smoking cessation interventions for adult smokers were not found effective in youth smokers, which may be partly explained by the vast differences in the pattern of tobacco use and determinants of quitting between adult and youth smokers. This calls for more research on novel intervention models to help young smokers quit. The HKU Youth Quitline provides free smoking cessation support for smokers aged below 25 years since August 2005 in Hong Kong. The service provides multisession peer-led telephone counselling with an individualised quit plan devised for each young smoker according to their responses. Since the counselling model depends on the information retrospectively recalled by the smokers, it may be prone to recall and social desirability biases and fail to capture the variability of youth smoking patterns and momentary changes in personal (e.g., mood) and situational (e.g., peer smoking) antecedents of smoking episodes. Recent advances in mobile technologies have enabled the use of more advanced and robust data collection approaches like ecological momentary assessment (EMA), which may benefit the counselling model by providing more ecologically valid data than traditional surveys. Previous studies have demonstrated the feasibility of using EMA to collect data on psychosocial processes and smoking behaviours in adolescent smokers. Therefore, we propose to develop and test a mobile EMA-based counselling intervention for youth smokers by conducting a pilot RCT.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 105
Est. completion date October 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 25 Years
Eligibility Inclusion Criteria: 1. Age between 15 to 25 years 2. Have smoked in the past 30 days 3. Own a smartphone with an mobile instant messaging app installed 4. Can communicate in Chinese Exclusion Criteria: Youth smokers who are participating in other smoking cessation studies or program other than the HKU Youth Quitline

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
EMA assessment
Subjects will be asked to complete 3 waves of ecological momentary assessment (EMA) about smoking cues and smoking consumption via mobile phone at the first, second and third month after baseline (total 6 weeks)
EMA-based cessation counselling
Subjects will receive tailored peer counselling based on the participants' EMA responses at 1-month and 3-month telephone follow-ups.
Usual peer counselling
Subjects will receive peer counselling through telephone during follow-ups (usual care), in which the counsellor will apply the 5As model and motivational interviewing techniques.

Locations

Country Name City State
Hong Kong HKU Youth Quitline Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (5)

Chan SS, Wong DC, Fong DY, Leung AY, Lam DO, Mak YW, Lam TH. The establishment and promotion of the first Youth Quitline in Hong Kong: challenges and opportunities. Eval Health Prof. 2008 Sep;31(3):258-71. doi: 10.1177/0163278708320156. Epub 2008 Jun 19. — View Citation

Fanshawe TR, Halliwell W, Lindson N, Aveyard P, Livingstone-Banks J, Hartmann-Boyce J. Tobacco cessation interventions for young people. Cochrane Database Syst Rev. 2017 Nov 17;11(11):CD003289. doi: 10.1002/14651858.CD003289.pub6. — View Citation

McClure EA, Tomko RL, Carpenter MJ, Treiber FA, Gray KM. Acceptability and compliance with a remote monitoring system to track smoking and abstinence among young smokers. Am J Drug Alcohol Abuse. 2018;44(5):561-570. doi: 10.1080/00952990.2018.1467431. Epub 2018 May 8. — View Citation

Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415. — View Citation

Van Zundert RM, Ferguson SG, Shiffman S, Engels R. Dynamic effects of craving and negative affect on adolescent smoking relapse. Health Psychol. 2012 Mar;31(2):226-34. doi: 10.1037/a0025204. Epub 2011 Sep 26. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Recruitment rate Proportion of participants among all eligible subjects Through recruitment completion, about 6 months
Other Retention rate Proportion of participants responding to telephone follow-up 6 months after randomisation
Primary Biochemically-validated tobacco abstinence Defined as a negative result of the iScreen OFD test for measuring salivary cotinine (with a cut-off of lower than 30ng/mL) 6 months after randomisation
Secondary Self-reported 7-day point-prevalence tobacco abstinence Being completely smoke-free in the past 7 days 3 months after randomisation
Secondary Self-reported 7-day point-prevalence tobacco abstinence Being completely smoke-free in the past 7 days 6 months after randomisation
Secondary Self-reported 30-day point-prevalence tobacco abstinence Being completely smoke-free in the past 30 days 3 months after randomisation
Secondary Self-reported 30-day point-prevalence tobacco abstinence Being completely smoke-free in the past 30 days 6 months after randomisation
Secondary Smoking reduction by at least 50% Smoking reduction by at least half of the baseline daily number of cigarettes 3 months after randomisation
Secondary Smoking reduction by at least 50% Smoking reduction by at least half of the baseline daily number of cigarettes 6 months after randomisation
See also
  Status Clinical Trial Phase
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Completed NCT04617444 - The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function N/A
Completed NCT02796391 - Facilitating Smoking Cessation With Reduced Nicotine Cigarettes Phase 2
Completed NCT03397511 - Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City N/A
Not yet recruiting NCT05188287 - A Culturally Tailored Smartphone Application for African American Smokers N/A
Recruiting NCT05264428 - The Effect of Honey on Lessening the Withdrawal Symptoms N/A
Recruiting NCT05846841 - Personalized Tobacco Treatment in Primary Care (MOTIVATE) N/A
Completed NCT04133064 - Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study N/A
Completed NCT03187730 - Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants Phase 4
Completed NCT03474783 - To Explore the Factors Affecting the Effectiveness of Smoking Cessation N/A
Completed NCT04635358 - Feasibility Study of Smoking Cessation for the Staff of a Hospital Center N/A
Terminated NCT03670264 - BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation N/A
Not yet recruiting NCT06307496 - VIDeOS for Smoking Cessation N/A
Completed NCT03206619 - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed NCT02905656 - Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit N/A
Completed NCT02997657 - Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial N/A
Completed NCT02562521 - A Smoking Cessation Intervention for Yale Dining Employees Phase 4
Completed NCT02239770 - Pharmacokinetics of Nicotine Film in Smokers N/A
Recruiting NCT02422914 - Benefits of Tobacco Free Cigarette N/A