Clinical trial NCT05725369: The Effects of Combined Lifestyle Intervention (CLI) in Patients With Inflammatory Bowel Disease (IBD)
Official title: The Effects of Combined Lifestyle Intervention (CLI) in Patients With Inflammatory Bowel Disease (IBD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Keywords: lifestyle
diet
combined lifestyle intervention
exercise
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥ 18 years old with a BMI ≥ 30 mg/kg2 or a BMI between 25 and 30 mg/kg2 and an increased risk of diabetes or cardiovascular disease, who are eligible to be referred to the CLI or have already been referred to the CLI.

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.

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.

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).

Primary outcomes:
measure: Decrease in bodyweight
timeFrame: 2 years
measure: Decrease in BMI
timeFrame: 2 years
measure: Decrease in waist circumference
timeFrame: 2 years
measure: Decrease in fat percentage
timeFrame: 2 years
measure: Quality of life
timeFrame: 2 years
Secondary outcomes:
measure: Adherence
timeFrame: 2 years
measure: Willingness
timeFrame: 2 years
measure: IBD related adverse events
timeFrame: 2 yera
Other outcomes:
Locations:
Study officials:
affiliation: Radboud University Medical Center (Radboudumc)
name: Marjolijn Duijvestein, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: