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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Lifestyle Intervention (CLI) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in bodyweight | Measured in kilograms | 2 years |
| Decrease in BMI | Measures in mg/kg2 | 2 years |
| Decrease in waist circumference | Measured in centimeters | 2 years |
| Decrease in fat percentage | Measured in percentages | 2 years |
| Quality of life | EQ-5D-5L score | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Adherence to the CLI (i.e. amount of patients to stop the CLI prematurely) | 2 years |
| Willingness | Willingness to partake in the CLI (and to be referred to the CLI) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dorien Oomkens, MD | Contact | +31650084590 | dorien.oomkens@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Marjolijn Duijvestein, MD PhD | Radboud University Medical Center (Radboudumc) | Principal Investigator |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| 2 years |
| IBD related adverse events | Incidence of IBD related adverse events during the study period | 2 yera |
| D001519 | Behavior |