Intervention Study on Weight Loss in Patients With Obesity

NCT07124832 | Recruiting

• 1 other identifier: 20.478.486/3150
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 3 months

Secondary Outcomes (4)

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

  Baseline and 3 months

• Change from Baseline in Waist Circumference at 3 Months

  Baseline and 3 months

• Association Between Weight Loss Percentage and Previous Attempts to Lose Weight

  Baseline and 3 months

• Correlation Between Weight Loss Percentage and Baseline Willingness

  Baseline and 3 months

Study Arms (2)

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.

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.

Interventions

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.

Socratic Questioning Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sıdıka Ece Yokuş: lead

Study Sites (1)

Manisa Celal Bayar University Mustafa Yardimci Education Family Health Center

Manisa, 45140, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raquel Gómez Bravo

  Centre Hospitalier Neuro-Psychiatrique, Luxembourg

  STUDY DIRECTOR

• Vinicius Anjos de Almeida

  University of Sao Paulo

  STUDY DIRECTOR

• Sandra León Herrera

  University of Zaragoza, Spain

  STUDY DIRECTOR

• Sıdıka E. Yokuş

  Manisa Celal Bayar University

  PRINCIPAL INVESTIGATOR

• Hüseyin Elbi

  Manisa Celal Bayar University

  STUDY DIRECTOR

Central Study Contacts

Sıdıka E. Yokuş

CONTACT

+905070615616; yokusece@gmail.com

Hüseyin Elbi

CONTACT

+905055569911; huseyinelbi.md@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 15, 2025
• Study Start: August 14, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)