NCT05629039

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

September 22, 2022

Last Update Submit

April 29, 2026

Conditions

Smoking Cessation

Keywords

Volitional help sheetsYoung adultsSmoking cessationIndonesia

Outcome Measures

Primary Outcomes (1)

  • Smoking Cessation

    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.

    6 months

Secondary Outcomes (2)

  • Nicotine dependence

    6 months

  • Intervention evaluation

    6 months

Study Arms (10)

Wave 1-Experimental Group

EXPERIMENTAL

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

Behavioral: Volitional Help Sheets

Wave 1-Control Group

NO INTERVENTION

The control group participants will complete the baseline questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention

Wave 2-Control group

NO INTERVENTION

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-Delayed VHS Group

EXPERIMENTAL

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).

Behavioral: Volitional Help Sheets

Wave 2-Early VHS Group

EXPERIMENTAL

This group will complete the one-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention

Behavioral: Volitional Help Sheets

Wave 2-Repeated VHS group

EXPERIMENTAL

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.

Behavioral: Volitional Help Sheets

Wave 3-Control Group

NO INTERVENTION

This group will complete the six-month follow-up questionnaires. Due to ethical consideration, in wave three the control group will be offered the opportunity to complete the VHS form after they complete the follow-up assessments and the scores will not be included in the analysis.

Wave 3-Delayed VHS Group

EXPERIMENTAL

This group will complete the six-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention

Behavioral: Volitional Help Sheets

Wave 3-Early VHS Group

EXPERIMENTAL

This group will complete the six-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention

Behavioral: Volitional Help Sheets

Wave 3-Repeated VHS Group

EXPERIMENTAL

This group will complete the six-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention

Behavioral: Volitional Help Sheets

Interventions

Volitional Help SheetsBEHAVIORAL

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.

Also known as: Volitional help sheets for smoking cessation
Wave 1-Experimental GroupWave 2-Delayed VHS GroupWave 2-Early VHS GroupWave 2-Repeated VHS groupWave 3-Delayed VHS GroupWave 3-Early VHS GroupWave 3-Repeated VHS Group

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Smokers whose ages are 20-45 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rina Rahmatika

Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Christopher Armitage

    University of Manchester

    PRINCIPAL INVESTIGATOR

  • Tim Millar

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

September 22, 2022

First Posted

November 29, 2022

Study Start

May 15, 2023

Primary Completion

September 30, 2024

Study Completion

September 30, 2025

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

The research team will receive anonymous data from the survey panel company. Therefore, there will be no identifiable data to be shared with other researchers.

Locations

GB(1)