ASSESSMENT OF THE NATURAL HISTORY AND PROGNOSTIC FACTORS OF THERAPEUTIC RESPONSE IN SUB-PHENOTYPES OF PATIENTS WITH OBESITY: THE BOLOBE STUDY
Recruiting now
Conditions studied: Obese Adults, Overweight , Obesity
In brief
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.
Key facts
- Study ID
- NCT07666425
- Run by
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- People needed
- 10000
- Starts
- 2026-05-30
- Expected to finish
- 2038-03-01
- Last updated by the study team
- 2026-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Obesity secondary to hypothalamic-pituitary disorders
- Obesity secondary to adrenal disorders
- Syndromic obesity
Where it is running
- IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna, Bologna, Italy (enrolling)
Full record on ClinicalTrials.gov
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