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

February 9, 2023 updated by: Radboud University Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Inflammatory Bowel Diseases

Intervention / Treatment

Behavioral: Combined Lifestyle Intervention (CLI)

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 Type

Observational

Enrollment (Anticipated)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in bodyweight Time Frame: 2 years	Measured in kilograms	2 years
Decrease in BMI Time Frame: 2 years	Measures in mg/kg2	2 years
Decrease in waist circumference Time Frame: 2 years	Measured in centimeters	2 years
Decrease in fat percentage Time Frame: 2 years	Measured in percentages	2 years
Quality of life Time Frame: 2 years	EQ-5D-5L score	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence Time Frame: 2 years	Adherence to the CLI (i.e. amount of patients to stop the CLI prematurely)	2 years
Willingness Time Frame: 2 years	Willingness to partake in the CLI (and to be referred to the CLI)	2 years
IBD related adverse events Time Frame: 2 yera	Incidence of IBD related adverse events during the study period	2 yera

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

Principal Investigator: Marjolijn Duijvestein, MD PhD, Radboud University Medical Center (Radboudumc)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2023

Primary Completion (ANTICIPATED)

February 1, 2025

Study Completion (ANTICIPATED)

February 1, 2025

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

February 9, 2023

First Posted (ACTUAL)

February 13, 2023

Study Record Updates

Last Update Posted (ACTUAL)