Intervention Study on Weight Loss in Patients With Obesity
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Socratic Questioning Method.
- Кому может быть актуально
- Состояния в реестре: Obesity. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Turkey (Türkiye)
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Pragmatic Randomized Controlled Pilot Trial for Weight Loss in Patients With Obesity: Assessment of the Socratic Questioning Method
Обзор
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.
Подробное описание
Work Packages:
1. 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:
The patient's assigned group will be recorded in the Family Medicine Information System, and a reminder note will be visible during each consultation. 5. 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. 6. 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. 7. Physician-patient consultation on Day 30:
The physician will provide counseling and take measurements. The next appointment (Day 60) will be scheduled. 8. Physician-patient consultation on Day 60:
The physician will provide counseling and take measurements. The next appointment (Day 90) will be scheduled. 9. Physician-patient consultation on Day 90:
Final measurements will be taken, and the study participation will be completed. 10. Data analysis:
Physicians will share the collected data with the research team. The data from this pilot study will be analyzed. 11. 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.
Вмешательства
- Поведенческое Socratic Questioning Method
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.
Первичные конечные точки
- Change from Baseline in Body Weight at 3 Months [Срок оценки: Baseline and 3 months]
Вторичные конечные точки (4)
- Change from Baseline in Body Mass Index (BMI) at 3 Months [Срок оценки: Baseline and 3 months]
- Change from Baseline in Waist Circumference at 3 Months [Срок оценки: Baseline and 3 months]
- Association Between Weight Loss Percentage and Previous Attempts to Lose Weight [Срок оценки: Baseline and 3 months]
- Correlation Between Weight Loss Percentage and Baseline Willingness [Срок оценки: Baseline and 3 months]
Критерии участия
Критерии включения
- Age between 18 and 65 years
- Body Mass Index (BMI) ≥ 30 kg/m²
- Willingness to participate in the study
Критерии исключения
- 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)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Организация здравоохранения
Центры проведения
Turkey (Türkiye) · 1 центр
- Manisa Celal Bayar University Mustafa Yardimci Education Family Health Center — Manisa
Идентификаторы
NCT: NCT07124832 · 20.478.486/3150