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NCT07666425Recruiting

ASSESSMENT OF THE NATURAL HISTORY AND PROGNOSTIC FACTORS OF THERAPEUTIC RESPONSE IN SUB-PHENOTYPES OF PATIENTS WITH OBESITY: THE BOLOBE STUDY

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)

Source: ClinicalTrials.gov · Last updated 24 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
10000 (estimated)
First submitted
19 Jun 2026
Start date
30 May 2026
Primary completion date
May 2036
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Diseases
Obesity
NCT number
NCT07666425

What you commit to

  • Study type: Observational
  • Planned participants: 10000
  • From 30 May 2026 to the primary completion date, May 2036
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Obesity secondary to hypothalamic-pituitary disorders
  • Obesity secondary to adrenal disorders

Other

  • Syndromic obesity

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Coordinator of this site? Confirm its status
BolognaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.