GLI-IBD: The Effects of Combined Lifestyle Intervention (CLI) in Patients With Inflammatory Bowel Disease (IBD)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This is an exploratory observational study of IBD patients ≥ 18 years old with a BMI ≥ 30 mg/kg2 or a BMI between 25 and 30 and an increased risk of diabetes or cardiovascular disease, who are or have been referred to the CLI.
During the 2-year CLI program, fitness measurements take place according to CLI protocol and by the CLI provider: bodyweight, BMI, waist circumference, fat percentage and the EQ-5D-5L are recorded at baseline and 1-year and 2-year timepoints. Whilst patients are offered a CLI referral, willingness to partake will be recorded.
Study Design
Outcome Measures
Primary Outcome Measures
- Decrease in bodyweight [2 years]
Measured in kilograms
- Decrease in BMI [2 years]
Measures in mg/kg2
- Decrease in waist circumference [2 years]
Measured in centimeters
- Decrease in fat percentage [2 years]
Measured in percentages
- Quality of life [2 years]
EQ-5D-5L score
Secondary Outcome Measures
- Adherence [2 years]
Adherence to the CLI (i.e. amount of patients to stop the CLI prematurely)
- Willingness [2 years]
Willingness to partake in the CLI (and to be referred to the CLI)
- IBD related adverse events [2 yera]
Incidence of IBD related adverse events during the study period
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years old;
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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;
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BMI ≥ 30 mg/kg2 or a BMI between 25 and 30 mg/kg2 and an increased risk of diabetes or cardiovascular disease;
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Patients that are or have been referred to the CLI;
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Oral informed consent must be obtained and documented in EPIC.
Exclusion Criteria:
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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);
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If female, the subject is pregnant or lactating;
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Illiteracy (disability to read and understand Dutch).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Radboud University Medical Center
Investigators
- Principal Investigator: Marjolijn Duijvestein, MD PhD, Radboud University Medical Center (Radboudumc)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-16137