NCT05725369

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2023-02-13
• Last updated: 2023-02-13