The Effects of Combined Lifestyle Intervention (CLI) in Patients With Inflammatory Bowel Disease (IBD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Decrease in waist circumference
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Decrease in waist circumference
时间窗: 2 years
Measured in centimeters
Decrease in fat percentage
时间窗: 2 years
Measured in percentages
Decrease in BMI
时间窗: 2 years
Measures in mg/kg2
Decrease in bodyweight
时间窗: 2 years
Measured in kilograms
Quality of life
时间窗: 2 years
EQ-5D-5L score
次要结局
- Adherence(2 years)
- Willingness(2 years)
- IBD related adverse events(2 yera)