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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05725369
Other study ID # 2022-16137
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date February 1, 2025

Study information

Verified date January 2023
Source Radboud University Medical Center
Contact Dorien Oomkens, MD
Phone +31650084590
Email dorien.oomkens@radboudumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date February 1, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Combined Lifestyle Intervention (CLI)
In the Netherlands, the combined lifestyle intervention (CLI, in Dutch: gecombineerde leefstijlinterventie (GLI)) is available for all Dutch citizens with a BMI = 30 mg/kg2 or a BMI between 25 and 30 mg/kg2 and an increased risk of diabetes or cardiovascular disease. The CLI aims to realize health benefits for people with a moderate weight-related health risk and consists of a two-year program with advice and counseling to improve health-related behavior such as physical activity and diet.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Radboud University Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Decrease in bodyweight Measured in kilograms 2 years
Primary Decrease in BMI Measures in mg/kg2 2 years
Primary Decrease in waist circumference Measured in centimeters 2 years
Primary Decrease in fat percentage Measured in percentages 2 years
Primary Quality of life EQ-5D-5L score 2 years
Secondary Adherence Adherence to the CLI (i.e. amount of patients to stop the CLI prematurely) 2 years
Secondary Willingness Willingness to partake in the CLI (and to be referred to the CLI) 2 years
Secondary IBD related adverse events Incidence of IBD related adverse events during the study period 2 yera
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