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NCT05725369
The Effects of Combined Lifestyle Intervention (CLI) in Patients With Inflammatory Bowel Disease (IBD)
Conditions: Inflammatory Bowel Diseases
Sex: All
Ages: 18 Years – N/A
Enrollment: 40
Sponsor: Radboud University Medical Center
Summary
A single-center observational study to investigate the effects of combined lifestyle intervention (CLI, in Dutch: gecombineerde leefstijlinterventie, GLI) in patients with Inflammatory Bowel Disease.
Eligibility Criteria
Inclusion Criteria:Age ≥ 18 years old;Diagnosis of IBD (Ulcerative Colitis, Crohn's Disease or IBD-Unclassified) confirmed by clinical, endoscopic, and histological evidence prior to screening as per standard criteria;BMI ≥ 30 mg/kg2 or a BMI between 25 and 30 mg/kg2 and an increased risk of diabetes or cardiovascular disease;Patients that are or have been referred to the CLI;Oral informed consent must be obtained and documented in EPIC.Exclusion Criteria:Serious underlying disease other than IBD that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study or would compromise subject safety (such as major neurological disorders, certain orthopedic impairments or any unstable, uncontrolled or severe systemic medical disorder);If female, the subject is pregnant or lactating;Illiteracy (disability to read and understand Dutch).
Source: ClinicalTrials.gov (NCT05725369). StuddyBuddy aggregates publicly available trial information.