Smoking CessationNCT07609199
3A-OR Very Brief Tobacco Cessation Intervention in Primary Care
A study testing 3A-OR very brief smoking cessation intervention in people with Smoking Cessation, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- 3A-OR very brief smoking cessation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Family Health Centers
Aydin
Melda Dibek, MD, +905305793069, mdbuyukdinc@adu.edu.tr
About this study
Official title: The Effectiveness of the 3A-OR Very Brief Tobacco Cessation Intervention in Primary Care: A Multicenter Pragmatic Trial Protocol
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.
Read the detailed description
3A-OR Model (Ask - Assess - Advise - Offer Assistance - Record) In this brief intervention algorithm, the physician primarily learns every patient's smoking status, assesses the smoker's motivation to quit, advises cessation with different approaches for the pre-contemplation and contemplation/preparation stages, then offers assistance, and finally records the encounter in the patient's file. Its motivational impact is reported to be higher than the other comparable models. The Turkish abbreviation is 3Ö-TK.
Theoretical Framework
- (A) LEARN! During visits the patient may share information about smoking. If not, the physician inquires within the routine assessment of habits: "Do you smoke cigarettes?" Smokers are briefly informed about the study and invited to participate; only those who consent proceed to the next steps.
- (A) ASSESS! The physician evaluates the smoker's motivation to quit: "Are you considering quitting smoking?" The smoker may be in the pre-contemplation, contemplation or preparation stage. If the smoker is in the PRE-CONTEMPLATION stage:
- (A) ADVISE! "Smoking is harmful to health. It causes cardiovascular disease, COPD, cancer and many other conditions. One out of every two lifelong smokers dies from a smoking-related cause. Quitting is the single most important action you can take for your health. I strongly advise you to stop smoking."
- (O) OFFER ASSISTANCE! "If you would like to talk about smoking, I can schedule a separate appointment for you (if the smoker agrees, the earliest possible slot is arranged). Should you consider quitting at any point, I am always available to help personally or to refer you to a smoking-cessation clinic." A brochure containing information on smoking and local cessation services is handed to the patient.
- (R) RECORD! The family physician documents the patient's smoking status and advice given. At every subsequent contact, the topic is revisited from where it left off, and the intervention is repeated.
If the smoker is in the CONTEMPLATION or PREPARATION stage 3. (A) ADVISE! "I commend you on your intention to quit smoking. Smoking is harmful to health and one in two smokers dies from a smoking-related cause. Quitting is the most important step you can take for your wellbeing. I encourage you to implement your plan as soon as possible." 4. (O) OFFER ASSISTANCE! "I can assist you throughout this process. If you wish, we can schedule a dedicated appointment. You may also seek support from a smoking-cessation clinic (hand the patient a brochure listing clinic details). Whenever you are ready, I can arrange an appointment for you." 5. (R) RECORD! The family physician records all smoking-related information. At each follow-up visit, the discussion continues from the previous point and the intervention is repeated.
- Conditions
- Smoking Cessation
- Being tested
- 3A-OR very brief smoking cessation intervention
- Keywords
- pragmatic clinical trial, smoking cessation, primary health care, brief intervention
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3A-OR very brief smoking cessation interventionBehavioural
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 | Role | What they receive |
|---|---|---|
| Study Group | Active comparator | participants who used tobacco products and underwent the intervention Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 3, 6 and 12-month follow ups
Secondary outcomes (1)
Motivational change
Changes in motivation to quit among smokers who have not quit tobacco use. For successful tobacco cessation, the key criterion will be that the individual has not used tobacco for at least the last 7 days at the three-month follow-up, at least the last 15 days at the six-month follow-up, and at least the last month at the one-year follow-up
Measured: At 3, 6 and 12-month follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melda Dibek, Aydin Adnan Menderes University
- Investigators
- Melda Dibek, MD, Principal investigator, Adnan Menders University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609199
- Sponsor's protocol ID
- Melda DİBEK
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the 3A-OR Very Brief Tobacco Cessation Intervention in Primary Care: A Multicenter Pragmatic Trial Protocol
- ClinicalTrials.gov ID
- NCT07609199
- Acronym / sponsor ID
- Melda DİBEK
- Conditions
- Smoking Cessation
- Keywords
- pragmatic clinical trial, smoking cessation, primary health care, brief intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
3A-OR Model (Ask - Assess - Advise - Offer Assistance - Record) In this brief intervention algorithm, the physician primarily learns every patient's smoking status, assesses the smoker's motivation to quit, advises cessation with different approaches for the pre-contemplation and contemplation/preparation stages, then offers assistance, and finally records the encounter in the patient's file. Its motivational impact is reported to be higher than the other comparable models. The Turkish abbreviation is 3Ö-TK.
Theoretical Framework
- (A) LEARN! During visits the patient may share information about smoking. If not, the physician inquires within the routine assessment of habits: "Do you smoke cigarettes?" Smokers are briefly informed about the study and invited to participate; only those who consent proceed to the next steps.
- (A) ASSESS! The physician evaluates the smoker's motivation to quit: "Are you considering quitting smoking?" The smoker may be in the pre-contemplation, contemplation or preparation stage. If the smoker is in the PRE-CONTEMPLATION stage:
- (A) ADVISE! "Smoking is harmful to health. It causes cardiovascular disease, COPD, cancer and many other conditions. One out of every two lifelong smokers dies from a smoking-related cause. Quitting is the single most important action you can take for your health. I strongly advise you to stop smoking."
- (O) OFFER ASSISTANCE! "If you would like to talk about smoking, I can schedule a separate appointment for you (if the smoker agrees, the earliest possible slot is arranged). Should you consider quitting at any point, I am always available to help personally or to refer you to a smoking-cessation clinic." A brochure containing information on smoking and local cessation services is handed to the patient.
- (R) RECORD! The family physician documents the patient's smoking status and advice given. At every subsequent contact, the topic is revisited from where it left off, and the intervention is repeated.
If the smoker is in the CONTEMPLATION or PREPARATION stage 3. (A) ADVISE! "I commend you on your intention to quit smoking. Smoking is harmful to health and one in two smokers dies from a smoking-related cause. Quitting is the most important step you can take for your wellbeing. I encourage you to implement your plan as soon as possible." 4. (O) OFFER ASSISTANCE! "I can assist you throughout this process. If you wish, we can schedule a dedicated appointment. You may also seek support from a smoking-cessation clinic (hand the patient a brochure listing clinic details). Whenever you are ready, I can arrange an appointment for you." 5. (R) RECORD! The family physician records all smoking-related information. At each follow-up visit, the discussion continues from the previous point and the intervention is repeated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Active comparator | Behavioral: 3A-OR very brief smoking cessation interventionparticipants who used tobacco products and underwent the intervention |
| Control Group | No intervention | –Participants who use tobacco products but were not subjected to the intervention, usual care |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3A-OR very brief smoking cessation interventionThe 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'. | Behavioural | Study Group |
Primary outcome
Smoking cessation success
Time frame: At 3, 6 and 12-month follow ups
Patient-reported success in quitting tobacco use among smokers in the intervention and control groups at the end of three, six, and twelve months
1 secondary outcome
Motivational change
Time frame: At 3, 6 and 12-month follow ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melda Dibek, MD principal investigator
Adnan Menders University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3A-OR very brief smoking cessation intervention in people with Smoking Cessation, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melda Dibek, MD (+905305793069, mdbuyukdinc@adu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation success (time frame: At 3, 6 and 12-month follow ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.