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

Volitional Help Sheet to Promote Smoking Cessation Among Young Adults in Indonesia

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05629039
Enrollment
2700
Registered
2022-11-29
Start date
2023-05-15
Completion date
2025-09-30
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

Volitional help sheets, Young adults, Smoking cessation, Indonesia

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.

Interventions

BEHAVIORALVolitional Help Sheets

The volitional help sheet is an intervention which provides an opportunity for people to actively plan their behavioural changes by using a list of situations and solutions. The list of situations are critical situations which provoke unwanted behaviour, and the solutions are the responses to overcome the situations which urge the unexpected behaviour. In the context of smoking behaviour, the list of situations is the situations that will provoke cigarette uptake and the list of solutions is the appropriate responses to reduce or stop the urge to smoke.

Sponsors

University of Manchester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Smoking Cessation6 monthsParticipants 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

MeasureTime frameDescription
Nicotine dependence6 monthsThe 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 evaluation6 monthsThe 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.

Countries

United Kingdom

Contacts

PRINCIPAL_INVESTIGATORChristopher Armitage

University of Manchester

PRINCIPAL_INVESTIGATORTim Millar

University of Manchester

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026