Simple Physical Exercise With Instant Messaging Support for Smoking Via "Quit to Win" Contest 2022 (QTW2022)

Smoking Cessation Clinical Trial

Official title:

Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2022: Simple Physical Exercise With Instant Messaging Support for Smoking Cessation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05430451
• Other study ID #: QTW2022
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 18, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project aims to test the effectiveness of an integrated intervention of brief cessation advice (AWARD) and simple physical exercise with Instant Messaging (IM) support compared with control participants among current smokers who joined the contest.

Description:

Although smoking prevalence is decreasing in Hong Kong, it accounts for over 7,000 deaths per year and a large amount of medical cost, long-term care, and productivity loss of US$ 688 million (0.6% Hong Kong GDP). Quitting is difficult because nicotine is highly addictive. Long-term habitual tobacco smoking could foster a series of physical and psychological dependence on nicotine, and thus induce cravings and nicotine withdrawal symptoms when remaining abstinent.

In addition to pharmacotherapy and behavioral counseling, exercise has shown promising effects on reducing craving, cigarette consumption, withdrawal symptoms, and increasing intention and attempt to quit. Randomized trials on smoking cessation have shown that vigorous or moderate exercise (including aerobics, brisk walking, and weightlifting) increases tobacco abstinence. However, these exercise-based smoking cessation trials were small-scaled with sample sizes ranging from 20 to 543, and mainly targeted the smokers who were motivated to quit (active treatment seekers). Most (15/20) of the vigorous or moderate exercises adopted in the smoking cessation trials required the participants to attend multiple exercise sessions (at least weekly for 5 months) under supervision or self-monitoring using equipment (e.g., pedometers) with a low proportion (<50%) of the participants achieved targeted level of attendance and exercise. The effects were short-term (end of treatment) and long-term (6 months or above) effects were uncertain, and cannot be generated in smokers who had low motivation to quit.

Mobile health (mHealth) is now a part of the World Health Organization's (WHO) strategies on combating smoking (http://www.who.int/tobacco/mhealth/en/) and has been used in many countries given its low cost and popular use. Instant messaging (IM) applications (apps) (e.g., WhatsApp, WeChat) are compatible with smartphones and allow sending interactive messages such as text, photos, video, animation, and files. The widespread availability of IM apps allows healthcare professionals to deliver health information and behavioral interventions through messaging. The QTW Contest 2017 using chat-based psychosocial support through IM apps effectively increased short-term (end of treatment, 3 months) and long-term (6 months since intervention initiation) smoking abstinence.

The chat-based IM support has the potential to support the use of other treatment components. The investigators aimed to test (1) the effectiveness of an integrated intervention of brief cessation advice (AWARD), simple physical exercise with Instant Messaging (IM) support compared with control participants among current smokers; (2) to explore participants' experience and perceptions towards the intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1031
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hong Kong residents aged 18 or above

• Smoke at least 1 tobacco stick (includes HTP) per day or use e-cigarette daily in the preceding 3-month

• Able to communicate in Chinese (including reading Chinese in IM)

• Saliva cotinine 30 ng/ml or above

• Intent to quit / reduce smoking

• Able to use the instant messaging tool (e.g., WhatsApp, WeChat) for communication.

Exclusion Criteria:

• Smokers who have communication barriers (either physically or cognitively)

• Smokers who are currently participating in other SC programmes or services

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• AWARD advice
Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refused to set quit date).
• Referral card
The content consists of brief information and highlights of existing smoking cessation services, contact methods, motivation information, and strong supporting messages or slogans.
• Self-help smoking cessation booklet
The contents include information about the benefits of quitting, smoking and diseases, methods to quit, how to handle withdrawal symptoms, declaration of quitting, etc.
• Simple physical exercise training
The simple exercises consist of a) Zero-time exercises (ZTEx), b) handgrip exercises, and c) resistance exercises. Participants will receive handgrips and elastic bands, and trained smoking cessation ambassadors will demonstrate and encourage the use of handgrip and elastic bands onsite with an instruction leaflet.
• Simple physical exercises with instant messaging support
During the 3-month instant messaging support, smoking cessation counselors will deliver regular messages to encourage the practices of simple physical exercise, provide strategies for managing craving and withdrawal symptoms, and provide information on smoking-related knowledge and available smoking cessation services. Our trained smoking cessation counselors will also provide real-time support upon participants' inquiries.
• SMS
SMS on follow-up survey reminders

Locations

Country	Name	City	State
China	Hong Kong Council on Smoking and Health (COSH)	Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Hong Kong Council on Smoking and Health

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemically validated abstinence	Defined as exhaled CO level <4ppm and saliva cotinine level =30 ng/ml	3-month follow-up
Primary	Biochemically validated abstinence	Defined as exhaled CO level <4ppm and saliva cotinine level =30 ng/ml	6-month follow-up
Secondary	Physical exercise level	Measured by international physical activity questionnaire - short form (IPAQ-SF). The scale assesses the types and intensity of physical activity and sitting time that people do as part of their daily lives (during the last 7 days) are considered to estimate total physical activity in metabolic equivalent of task (MET)-min/week and time spent sitting.	3-month follow-up
Secondary	Physical exercise level	Measured by international physical activity questionnaire - short form(IPAQ-SF). The scale assesses the types and intensity of physical activity and sitting time that people do as part of their daily lives (during the last 7 days) are considered to estimate total physical activity in metabolic equivalent of task (MET)-min/week and time spent sitting.	6-month follow-up
Secondary	Smoking quit rate change from baseline at 3-month follow-up	Self-reported 7-day point prevalence (pp) quit rate at 3-month between the two groups	3-month follow-up
Secondary	Smoking quit rate change from baseline at 6-month follow-up	Self-reported 7-day point prevalence (pp) quit rate at 6-month between the two groups	6-month follow-up
Secondary	Smoking reduction rate change from baseline at 3-month follow-up	Rate of smoking reduction by at least half of baseline amount in the two groups	3-month follow-up
Secondary	Smoking reduction rate change from baseline at 6-month follow-up	Rate of smoking reduction by at least half of baseline amount in the two groups	6-month follow-up
Secondary	Intervention compliance at the end of treatment at 3 months follow-up	Rate of self-reported practice and frequency of simple physical exercise, IM engagement (replied for at least 2 messages confirmed by the conversation log)	3-month follow-up