Implementing an Intervention Named Volitional Help Sheets to Reduce Smoking Behaviour Among Young Adults in Indonesia

Not Applicable

Recruiting

• Conditions: Smoking Cessation
• Interventions: Behavioral: Volitional Help Sheets

• Registration Number: NCT05629039
• Lead Sponsor: University of Manchester

Brief Summary

Indonesia is one of the countries that does not sign The World Health Organization Framework Convention on Tobacco Control (WHO-FCTC), and the numbers of Indonesian smokers increase every year. The Volitional-Help Sheet (VHS) has been used successfully to help people quit smoking, but has not yet been tested in Indonesia. The present study aims to adapt and implement the VHS to promote smoking cessation among smokers aged 20- 45 years. The main outcome measure is smoking abstinence; secondary outcomes are nicotine dependence, and capabilities, opportunities and motivations.

Detailed Description

The main outcome measure is smoking abstinence; secondary outcomes are nicotine dependence, and capabilities, opportunities and motivations. All participants will be smokers aged 20-45 years who will complete self-report measures of outcomes over three waves of data collection. Once baseline measures are collected, participants will be randomised at wave 1 to intervention versus control condition. Participants in the intervention group will complete the VHS for smoking cessation in addition to the baseline measures. At wave 2, one-month following wave 1, participants will again be randomised to intervention (complete the VHS) and control condition. There will thus be four conditions: control, early intervention, late intervention and repeated intervention. Outcomes will be assessed at wave 3, six-months after wave 2.

Study Timeline

• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-11-16
• Study First Posted: 2022-11-29
• Study Start: 2023-05-15
• Primary Completion: 2024-09-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2700

Inclusion Criteria

• Smokers whose ages are 20-45 years old

Exclusion Criteria

• Non-smokers whose ages are below 20 years old and above 45 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Wave 1-Experimental Group	Volitional Help Sheets	The experimental group in Wave 1 will complete the baseline questionnaires (the socio-demographic, FTND, and COM-B questionnaires) followed by both the if-then list and the if-then link from the Volitional-Help Sheet as manipulations. The if-then list consists of several situations and solutions linked to smoking uptake in the volitional help sheet and the group will be informed that the activity will help to stop smoking. In addition, the if-then link consists of the situations in which people are urged to smoke and then link them to solutions that are most likely to help them abstain from starting smoking
Wave 3-Delayed VHS Group	Volitional Help Sheets	This group will complete the six-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention
Wave 2-Delayed VHS Group	Volitional Help Sheets	This group will receive the (delayed) Volitional Help Sheets intervention after completing the one-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire).
Wave 2-Early VHS Group	Volitional Help Sheets	This group will complete the one-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention
Wave 2-Repeated VHS group	Volitional Help Sheets	This group will complete the one-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire), and receive a repeated, booster VHS intervention.
Wave 3-Repeated VHS Group	Volitional Help Sheets	This group will complete the six-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention
Wave 3-Early VHS Group	Volitional Help Sheets	This group will complete the six-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention

Primary Outcome Measures

Name	Time	Method
Smoking Cessation	6 months	Participants will complete a self-report questionnaire to assess their cigarette uptake by ticking one of the following options: (a) I have never smoked (b) I have only tried smoking once (c) I used to smoke sometimes, but I never smoke cigarettes now (d) I sometimes smoke cigarettes now, but I do not smoke as many as one a week (e) I usually smoke between one and six cigarettes a week (f) I usually smoke more than six cigarettes a week. The code for the response of options "a-d" is 0, and "e-f" is 1.

Secondary Outcome Measures

Name	Time	Method
Nicotine dependence	6 months	The Fagerstrom nicotine dependence scale will assess nicotine dependence. The scoring method in FTND is 0 to 1 for yes/no items and a score of 0 to 3 for the multiple-choice items. The items are summed to yield a total score of 0-10. The higher the total FTND score, the more intense the smoker's physical dependence on nicotine.
Intervention evaluation	6 months	The Capability Opportunity Motivation-Behaviour (COM-B) Questionnaire will measure how the intervention contributes to the behaviour changes. The higher the score, the more the intervention contributes to the behaviour changes.

Trial Locations

Locations (1)

Rina Rahmatika; 🇬🇧 Manchester, United Kingdom