NCT07666425 ASSESSMENT OF THE NATURAL HISTORY AND PROGNOSTIC FACTORS OF THERAPEUTIC RESPONSE IN SUB-PHENOTYPES OF PATIENTS WITH OBESITY: THE BOLOBE STUDY
| NCT ID | NCT07666425 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Obese Adults |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2026-05-30 |
| Primary Completion | 2036-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2026-05-30 with a primary completion date of 2036-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Obesity secondary to hypothalamic-pituitary disorders * Obesity secondary to adrenal disorders * Syndromic obesity
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07666425 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obese Adults. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07666425 currently recruiting?
Yes, NCT07666425 is actively recruiting participants. Contact the research team at marialetizia.petroni@unibo.it for enrollment information.
Where is the NCT07666425 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT07666425 clinical trial?
NCT07666425 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 10,000 participants.