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NCT Number: NCT07124832

Intervention Study on Weight Loss in Patients With Obesity

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manisa Celal Bayar University Mustafa Yardimci Education Family Health Center

Manisa, 45140, Turkey (Türkiye)

Location status: Recruiting

Location contact

Hüseyin Elbi

SUB_INVESTIGATOR

Sıdıka E. Yokuş

CONTACT

[email protected]

+905070615616

Sıdıka E. Yokuş

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 65 years
  • Body Mass Index (BMI) ≥ 30 kg/m²
  • Willingness to participate in the study

Exclusion criteria

  • 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
  • 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)

Treatment and study plan

Socratic Questioning Method

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change from Baseline in Body Mass Index (BMI) at 3 Months

    Time frame: Baseline and 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.

  2. Change from Baseline in Waist Circumference at 3 Months

    Time frame: Baseline and 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.

  3. Association Between Weight Loss Percentage and Previous Attempts to Lose Weight

    Time frame: Baseline and 3 months

    Association between percentage weight loss from baseline to 3 months and self-reported previous weight loss attempts at baseline (yes/no).

  4. Correlation Between Weight Loss Percentage and Baseline Willingness

    Time frame: Baseline and 3 months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Hüseyin Elbi

CONTACT

[email protected]

+905055569911

Sıdıka E. Yokuş

CONTACT

[email protected]

+905070615616

Sponsors and collaborators

Lead sponsor

Sıdıka Ece Yokuş

Other

Registry information

Official study title

A Pragmatic Randomized Controlled Pilot Trial for Weight Loss in Patients With Obesity: Assessment of the Socratic Questioning Method

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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