A Pragmatic Randomized Controlled Pilot Trial for Weight Loss in Patients With Obesity: Assessment of the Socratic Questioning Method
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from Baseline in Body Weight at 3 Months
研究概览
简要总结
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.
详细描述
Work Packages:
- Providing training to physicians on Socratic questioning:
Training will be delivered online by an instructor experienced in cognitive behavioral therapy. 2. 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. 3. 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. 4. Recording group assignment in the health information system:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •Body Mass Index (BMI) ≥ 30 kg/m²
- •Willingness to participate in the study
排除标准
- •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)
研究组 & 干预措施
Socratic Questioning Group
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.
干预措施: Socratic Questioning Method (Behavioral)
Regular Care Group
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.
结局指标
主要结局
Change from Baseline in Body Weight at 3 Months
时间窗: 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.
次要结局
- 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)
研究者
Sıdıka Ece Yokuş
Research Assistant
Celal Bayar University