ObesityNCT07124832
Intervention Study on Weight Loss in Patients With Obesity
A study testing Socratic Questioning Method in people with Obesity, run by Sıdıka Ece Yokuş at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate the feasibility of using Socratic questioning as an alternative method for weight loss in adult patients with obesity (aged 18 to 65) in a primary care setting. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Socratic Questioning Method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Aug 2025to Nov 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Body Mass Index (BMI) ≥ 30 kg/m²
- Willingness to participate in the study
Who cannot join
- Pregnancy or breastfeeding
- Presence of active psychosis or manic episode
- Intellectual disability
- Severe depression or personality disorder
- Auto- or hetero-aggressive behavior
- Reported use of psychoactive substances
Show all 10Show fewer
- Suicidal ideation
- Participation in another weight loss program within the last 6 months
- Use of medications that cause long-term weight gain or loss
- Detection of psychopathology based on the Hospital Anxiety and Depression Scale (HADS)
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, 1 recruiting
- Recruiting
Manisa Celal Bayar University Mustafa Yardimci Education Family Health Center
Manisa, 45140
Sıdıka E. Yokuş, +905070615616, yokusece@gmail.com
Hüseyin Elbi
About this study
Official title: A Pragmatic Randomized Controlled Pilot Trial for Weight Loss in Patients With Obesity: Assessment of the Socratic Questioning Method
The goal of this clinical trial is to evaluate the feasibility of using Socratic questioning as an alternative method for weight loss in adult patients with obesity (aged 18 to 65) in a primary care setting.
The main question it aims to answer is:
Read more
-Is Socratic questioning an effective alternative approach for promoting weight loss in patients with obesity?
Researchers will compare participants receiving Socratic questioning during follow-up visits with those receiving regular care to see if the intervention leads to greater weight loss.
Participants will:
- Complete a baseline questionnaire including 9 demographic questions and the 14-item Hospital Anxiety and Depression Scale (approx. 5 minutes).
- Attend five in-person follow-up visits with their family physician over a 3-month period (every 15 or 30 days), where they will receive brief counseling (10-15 minutes per visit) and have their weight, height, and waist circumference measured.
- Complete a 17-question final questionnaire at the end of 3 months (approx. 10-15 minutes).
- Be referred to mental health services if necessary, based on initial screening results.
Read the detailed description
Work Packages:
- Providing training to physicians on Socratic questioning: Training will be delivered online by an instructor experienced in cognitive behavioral therapy.
- Recruitment of patients: During routine outpatient visits, physicians will assess patients diagnosed with obesity according to inclusion and exclusion criteria. Eligible patients will be recruited after providing informed consent. Patients will complete an information form and the Hospital Anxiety and Depression Scale (HADS). Those with significant psychopathology will be referred to a specialist for psychiatric evaluation. A first appointment (Day 0) will be scheduled.
- Group allocation: After recruiting a patient, the physician will contact the research team to learn the patient's group assignment. The physician will be informed about the assigned group. Group allocation will be based on a pre-prepared list using computer-assisted block randomization.
- Recording group assignment in the health information system: The patient's assigned group will be recorded in the Family Medicine Information System, and a reminder note will be visible during each consultation.
- Physician-patient consultation on Day 0: The physician will take measurements and provide counseling about obesity. In the intervention group, the physician will apply the Socratic questioning technique. In the control group, the physician will follow routine obesity management practices. The next appointment (Day 15) will be scheduled.
- Physician-patient consultation on Day 15: The physician will provide counseling about obesity. No measurements will be taken at this visit. The next appointment (Day 30) will be scheduled.
- Physician-patient consultation on Day 30: The physician will provide counseling and take measurements. The next appointment (Day 60) will be scheduled.
- Physician-patient consultation on Day 60: The physician will provide counseling and take measurements. The next appointment (Day 90) will be scheduled.
- Physician-patient consultation on Day 90: Final measurements will be taken, and the study participation will be completed.
- Data analysis: Physicians will share the collected data with the research team. The data from this pilot study will be analyzed.
- Process evaluation:
At the end of the study, surveys including Likert-scale, multiple-choice, and open-ended questions will be administered to physicians and patients in the intervention group by the research team.
- Conditions
- Obesity
- Being tested
- Socratic Questioning Method
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socratic Questioning MethodBehavioural
Socratic questioning is a method in which behaviour is examined through questions such as "what, where, which, who, when, how, and why". It consists of four stages: defining the problem, evaluating and identifying alternatives, redefining, and discussing feasible outcomes. Through this process, individuals develop their critical thinking skills and make self-evaluations.
| Study group | Role | What they receive |
|---|---|---|
| Socratic Questioning Group | Active comparator | Participants in the intervention group will be followed up by physicians using the Socratic questioning technique. Face-to-face meetings will be held on the 0th, 15th, 30th and 60th days, and each session will take approximately 10-15 minutes. Physicians will use a checklist and ICD-10 code (E66: Obesity) when recording participant notes. The group to which the participant is assigned will be indicated in the Family Medicine Information System, and this warning note will be visible to physicians at each examination. Researchers will not interfere with the content of the interview, and physicians will be given flexibility to apply the Socratic questioning technique according to the needs of the participant. Receives: Behavioral: Socratic Questioning Method |
| Regular Care Group | No intervention | Participants in the control group will be followed up with the routine obesity approach used by physicians in their daily practice. Physicians will maintain the standard of care they normally give to patients with obesity. This approach may include nutritional advice, physical activity recommendations, and general lifestyle change advice, but Socratic questioning techniques will not be used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Body Weight at 3 Months
Body weight will be measured in kilograms using a calibrated digital scale. The outcome is the difference in percent change in body weight from baseline to 3 months between the Socratic questioning intervention group and the regular care control group.
Measured: Baseline and 3 months
Secondary outcomes (4)
Change from Baseline in Body Mass Index (BMI) at 3 Months
Body Mass Index will be measured in kg/m², calculated from weight (calibrated digital scale) and height (stadiometer). The outcome is the absolute change in BMI from baseline to 3 months.
Measured: Baseline and 3 months
Change from Baseline in Waist Circumference at 3 Months
Waist circumference will be measured in centimeters using a non-elastic tape. The outcome is the absolute change in waist circumference (cm) from baseline to 3 months.
Measured: Baseline and 3 months
Association Between Weight Loss Percentage and Previous Attempts to Lose Weight
Association between percentage weight loss from baseline to 3 months and self-reported previous weight loss attempts at baseline (yes/no).
Measured: Baseline and 3 months
Correlation Between Weight Loss Percentage and Baseline Willingness
Correlation between percentage weight loss from baseline to 3 months and baseline willingness to create behavioral change score measured using a self-reported numerical rating scale (0-10, where 0=not willing at all and 10=extremely willing).
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start14 Aug 2025
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to intervention and control groups at a 1:1 ratio using the block randomization method (block size 6) with a computer-aided program.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sıdıka Ece Yokuş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sıdıka Ece Yokuş, Manisa Celal Bayar University
- Investigators
- Raquel Gómez Bravo, Study director, Centre Hospitalier Neuro-Psychiatrique, LuxembourgVinicius Anjos de Almeida, Study director, University of Sao PauloSandra León Herrera, Study director, University of Zaragoza, SpainSıdıka E. Yokuş, Principal investigator, Manisa Celal Bayar UniversityHüseyin Elbi, Study director, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124832
- Sponsor's protocol ID
- 20.478.486/3150
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data sharing plan was made due to the statement 'Your personal information will not be shared with any other person or organisation' in the ethics committee application file.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Controlled Pilot Trial for Weight Loss in Patients With Obesity: Assessment of the Socratic Questioning Method
- ClinicalTrials.gov ID
- NCT07124832
- Acronym / sponsor ID
- 20.478.486/3150
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sıdıka Ece YokuşUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 15 Aug 2025 (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.
The goal of this clinical trial is to evaluate the feasibility of using Socratic questioning as an alternative method for weight loss in adult patients with obesity (aged 18 to 65) in a primary care setting.
The main question it aims to answer is:
-Is Socratic questioning an effective alternative approach for promoting weight loss in patients with obesity?
Researchers will compare participants receiving Socratic questioning during follow-up visits with those receiving regular care to see if the intervention leads to greater weight loss.
Participants will:
- Complete a baseline questionnaire including 9 demographic questions and the 14-item Hospital Anxiety and Depression Scale (approx. 5 minutes).
- Attend five in-person follow-up visits with their family physician over a 3-month period (every 15 or 30 days), where they will receive brief counseling (10-15 minutes per visit) and have their weight, height, and waist circumference measured.
- Complete a 17-question final questionnaire at the end of 3 months (approx. 10-15 minutes).
- Be referred to mental health services if necessary, based on initial screening results.
Detailed description
Work Packages:
- Providing training to physicians on Socratic questioning: Training will be delivered online by an instructor experienced in cognitive behavioral therapy.
- Recruitment of patients: During routine outpatient visits, physicians will assess patients diagnosed with obesity according to inclusion and exclusion criteria. Eligible patients will be recruited after providing informed consent. Patients will complete an information form and the Hospital Anxiety and Depression Scale (HADS). Those with significant psychopathology will be referred to a specialist for psychiatric evaluation. A first appointment (Day 0) will be scheduled.
- Group allocation: After recruiting a patient, the physician will contact the research team to learn the patient's group assignment. The physician will be informed about the assigned group. Group allocation will be based on a pre-prepared list using computer-assisted block randomization.
- Recording group assignment in the health information system: The patient's assigned group will be recorded in the Family Medicine Information System, and a reminder note will be visible during each consultation.
- Physician-patient consultation on Day 0: The physician will take measurements and provide counseling about obesity. In the intervention group, the physician will apply the Socratic questioning technique. In the control group, the physician will follow routine obesity management practices. The next appointment (Day 15) will be scheduled.
- Physician-patient consultation on Day 15: The physician will provide counseling about obesity. No measurements will be taken at this visit. The next appointment (Day 30) will be scheduled.
- Physician-patient consultation on Day 30: The physician will provide counseling and take measurements. The next appointment (Day 60) will be scheduled.
- Physician-patient consultation on Day 60: The physician will provide counseling and take measurements. The next appointment (Day 90) will be scheduled.
- Physician-patient consultation on Day 90: Final measurements will be taken, and the study participation will be completed.
- Data analysis: Physicians will share the collected data with the research team. The data from this pilot study will be analyzed.
- Process evaluation:
At the end of the study, surveys including Likert-scale, multiple-choice, and open-ended questions will be administered to physicians and patients in the intervention group by the research team.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be assigned to intervention and control groups at a 1:1 ratio using the block randomization method (block size 6) with a computer-aided program.
| Arm | Type | Receives |
|---|---|---|
| Socratic Questioning Group | Active comparator | Behavioral: Socratic Questioning MethodParticipants in the intervention group will be followed up by physicians using the Socratic questioning technique. Face-to-face meetings will be held on the 0th, 15th, 30th and 60th days, and each session will take approximately 10-15 minutes. Physicians will use a checklist and ICD-10 code (E66: Obesity) when recording participant notes. The group to which the participant is assigned will be indicated in the Family Medicine Information System, and this warning note will be visible to physicians at each examination. Researchers will not interfere with the content of the interview, and physicians will be given flexibility to apply the Socratic questioning technique according to the needs of the participant. |
| Regular Care Group | No intervention | –Participants in the control group will be followed up with the routine obesity approach used by physicians in their daily practice. Physicians will maintain the standard of care they normally give to patients with obesity. This approach may include nutritional advice, physical activity recommendations, and general lifestyle change advice, but Socratic questioning techniques will not be used. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years
- Body Mass Index (BMI) ≥ 30 kg/m²
- Willingness to participate in the study
Key exclusion criteria (10 listed)
- Pregnancy or breastfeeding
- Presence of active psychosis or manic episode
- Intellectual disability
- Severe depression or personality disorder
- Auto- or hetero-aggressive behavior
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 |
|---|---|---|
| Socratic Questioning MethodSocratic questioning is a method in which behaviour is examined through questions such as "what, where, which, who, when, how, and why". It consists of four stages: defining the problem, evaluating and identifying alternatives, redefining, and discussing feasible outcomes. Through this process, individuals develop their critical thinking skills and make self-evaluations. | Behavioural | Socratic Questioning Group |
Primary outcome
Change from Baseline in Body Weight at 3 Months
Time frame: Baseline and 3 months
Body weight will be measured in kilograms using a calibrated digital scale. The outcome is the difference in percent change in body weight from baseline to 3 months between the Socratic questioning intervention group and the regular care control group.
4 secondary outcomes
Change from Baseline in Body Mass Index (BMI) at 3 Months
Time frame: Baseline and 3 months
Change from Baseline in Waist Circumference at 3 Months
Time frame: Baseline and 3 months
Association Between Weight Loss Percentage and Previous Attempts to Lose Weight
Time frame: Baseline and 3 months
Correlation Between Weight Loss Percentage and Baseline Willingness
Time frame: Baseline and 3 months
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 29 Aug 2025.
- Individual participant dataSharing planned: No. No data sharing plan was made due to the statement 'Your personal information will not be shared with any other person or organisation' in the ethics committee application file.
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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.
Raquel Gómez Bravo study director
Centre Hospitalier Neuro-Psychiatrique, Luxembourg
Vinicius Anjos de Almeida study director
University of Sao Paulo
Sandra León Herrera study director
University of Zaragoza, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socratic Questioning Method in people with Obesity, run by Sıdıka Ece Yokuş 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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 29 Aug 2025. 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 Sıdıka E. Yokuş (+905070615616, yokusece@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Body Weight at 3 Months (time frame: Baseline and 3 months). 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 29 Aug 2025.