The Effects of Combined Lifestyle Intervention (CLI) in Patients With Inflammatory Bowel Disease (IBD)

Inflammatory Bowel Diseases Clinical Trial

— GLI-IBD  

Official title:

The Effects of Combined Lifestyle Intervention (CLI) in Patients With Inflammatory Bowel Disease (IBD)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05725369
• Other study ID #: 2022-16137
• Status: Not yet recruiting
• 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
• 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
• 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).

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

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