NCT07609199

Brief Summary

Introduction: Türkiye is far from the World Health Organization (WHO)'s target of reducing tobacco use prevalence by 30% by 2025. Most tobacco users consider quitting, and most have attempted to quit at least once. However, the success rate of quitting on one's own is quite low. Studies demonstrating that very brief tobacco cessation interventions delivered by healthcare professionals increase cessation rates have almost entirely been conducted in hospital settings. The aim of this trial is to investigate the effectiveness of implementing the 3A-OR (Ask - Assess - Advise - Offer Assistance - Record) very brief tobacco cessation intervention in routine primary care family medicine practice on the success of tobacco cessation. Methods/design: This protocol describes a two-arm, multicenter pragmatic trial for adolescent and adult tobacco users. The project will be carried out in family health centers in 21 study sites across the 12 statistical regions of Türkiye. In the intervention arm, volunteer family physicians will implement the 3A-OR very brief tobacco cessation intervention to their patients as part of their routine clinical practice. The intervention consists of the following steps: 'asking patients about their tobacco use status', 'assessing users' motivation to quit', 'advising quitting based on their motivation status', 'offering cessation assistance', and 'recording information regarding patients' tobacco use status and repeating the intervention at each patient contact'. Routine practice in family health centers will constitute the control group. Data will be collected using standard questionnaire forms at baseline and during follow-up interviews at 3, 6, and 12 months. Tobacco cessation rate and increase in smokers' motivation were the primary outcomes of the trial. Discussion: If the 3A-OR very brief tobacco cessation intervention is found to be effective, the results of this trial will provide evidence that will encourage the widespread use of the intervention in primary care family health centers. The study results are intended to be disseminated through the Family Medicine Academy Association website, conference presentations, and scientific publications.

Trial Health

63
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Trial Health Score

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

Enrollment
2,400

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Jun 2027

First Submitted

Initial submission to the registry

April 28, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

April 28, 2026

Last Update Submit

May 21, 2026

Conditions

Keywords

pragmatic clinical trialsmoking cessationprimary health carebrief intervention

Outcome Measures

Primary Outcomes (1)

  • Smoking cessation success

    Patient-reported success in quitting tobacco use among smokers in the intervention and control groups at the end of three, six, and twelve months

    At 3, 6 and 12-month follow ups

Secondary Outcomes (1)

  • Motivational change

    At 3, 6 and 12-month follow ups

Study Arms (2)

Study Group

ACTIVE COMPARATOR

participants who used tobacco products and underwent the intervention

Behavioral: 3A-OR very brief smoking cessation intervention

Control Group

NO INTERVENTION

Participants who use tobacco products but were not subjected to the intervention, usual care

Interventions

The intervention consists of the following steps: 'asking patients about their tobacco use status', 'assessing users' motivation to quit', 'advising quitting based on their motivation status', 'offering cessation assistance', and 'recording information regarding patients' tobacco use status and repeating the intervention at each patient contact'.

Study Group

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being aged 15 years and older (including pregnant and breastfeeding women);
  • Having used any tobacco product at least once daily within the last month;
  • All smokers, regardless of their intention to quit tobacco use;
  • Providing a phone number for follow-up;
  • Being able to read and speak Turkish;
  • Signing the informed consent form.

You may not qualify if:

  • Using tobacco products less than once per day;
  • Having made an attempt to quit tobacco use within the last month;
  • Having impaired cognitive functions;
  • Having participated in another study on tobacco use within the past year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Health Centers

Aydin, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Melda Dibek, MD

    Adnan Menders University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The project will be conducted in family health centers located in 21 study sites across the 12 statistical regions of Türkiye. In the intervention arm, volunteer family physicians will implement the 3A-OR very brief tobacco cessation intervention as part of their routine clinical practice. The intervention consists of the following steps: ascertaining patients' tobacco product use status, assessing users' motivation to quit, advising cessation according to their level of motivation, offering cessation assistance, and recording information regarding patients' tobacco use status and repeating the intervention at every patient encounter. Routine practice in family health centers will constitute the control group. Data will be collected at baseline and during follow-up interviews at 3, 6, and 12 months using standardized questionnaire forms. Tobacco cessation rates and increases in participants' motivation constitute the primary outcomes of the trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 27, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

May 27, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations