ASSESSMENT OF THE NATURAL HISTORY AND PROGNOSTIC FACTORS OF THERAPEUTIC RESPONSE IN SUB-PHENOTYPES OF PATIENTS WITH OBESITY: THE BOLOBE STUDY (BOLOgna for OBEsity Follow-up BOLOBE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
研究概览
简要总结
The study is observational and single-center and involves (i) the establishment of a retrospective and prospective data collection, and (ii) the development of prognostic and predictive models of response to obesity therapies using statistical modeling and machine learning techniques, exclusively for research purposes.
Data collection will be carried out for each patient diagnosed with obesity or overweight whose first visit to the center occurred from January 1, 2000 up to the start of the study, as well as for patients accessing the center during the subsequent 5 years, including patients who died or were lost to follow-up.
With respect to the primary objective, an interim analysis is planned on the retrospective cohort only, once the collection of data already available at study start has been completed for patients with at least 5 years of follow-up.
Data related to instrumental and laboratory examinations and therapeutic interventions, including pharmacological treatments and group-based educational and behavioral therapies, conducted in accordance with routine clinical practice and the most recent relevant national and international guidelines, will be extracted from the electronic health records routinely used at the study center.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Body mass index (BMI) ≥ 30 kg/m², or BMI ≥ 25 kg/m² with at least one cardiometabolic comorbidity
- •Provision of written informed consent
排除标准
- •Obesity secondary to hypothalamic-pituitary disorders
- •Obesity secondary to adrenal disorders
- •Syndromic obesity
