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| Name | Class |
|---|---|
| Medical Center Haaglanden | OTHER |
| Voeding Leeft | UNKNOWN |
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Chronic fatigue is highly prevalent in patients with conditions characterized by chronic inflammation of the gastrointestinal tract, also known as Inflammatory Bowel Disease (IBD). Chronic fatigue has multiple causes, including alterations in immune system or gut microbiota, psychological factors, and sleeping problems. Unsurprisingly, fatigue has been associated with decreased quality of life, general well-being, and work productivity. Very few patients experience resolution in fatigue, emphasizing the need for new therapies. It has been shown that lifestyle interventions can improve most of fatigue-driving factors. Hence, the investigators hypothesize that a multimodal lifestyle intervention focusing on nutrition, sleep, stress, and exercise will improve chronic fatigue in patients with IBD. During this multicenter, controlled trial, the investigators will compare a multimodal lifestyle intervention to a standard therapy (i.e., an informational brochure on how to cope with chronic fatigue).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | The control group will receive the current standard of care: an informational brochure on how to cope with fatigue. |
|
| Lifestyle intervention | Experimental | Participants will undergo a multimodal lifestyle intervention, which focuses on nutrition, sleep, stress, and exercise. The lifestyle intervention includes digital lessons/webinars and online counseling by a nutritionist and a lifestyle coach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention: Live with IBD | Behavioral | A digital lifestyle intervention divided into two phases:
During the Intensive Phase, participants will receive regular counseling by a nutritionist and a lifestyle coach in groups of 25 people. Participants will also follow five online meetings focusing on either nutrition, exercise, sleep, and stress. In addition, participants will have 24/7 access to an online platform that contains additional information, challenges, recipes, and peer-support groups. Finally, during the facultative phase, participants can attend smaller group sessions for additional counseling by a nutritionist or a lifestyle coach; these sessions will be organized every six to 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue at six months | Percentage of patients who experience a reduction in fatigue at six months compared between the intervention and the control group. The reduction in fatigue is defined as any increase in The Functional Assessment of Chronic Illness Therapy - Fatigue ((FACIT-F) score (0-160 with lower scores indicating worse fatigue) at six months compared with the baseline. | Six months after starting the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in fatigue (FACIT-F) | Mean change in fatigue (measured by FACIT-F questionnaire 0-160 with lower scores indicating worse fatigue) compared between the intervention and the control; compared at different study time points. | at three months, at 12 months after the start of the intervention. |
| Mean change in fatigue (fatigue VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| P.W.J. Maljaars, MD, PhD | LUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center (LUMC) | Leiden | 2333ZA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40243391 | Derived | Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005221 | Fatigue |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
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| Control group | Other | The standard of care for patients with IBD suffering from chronic fatigue. |
|
Mean change in fatigue (measured by a fatigue visual analog scale (VAS) 0-10 with higher scores indicating worse fatigue) compared between the intervention and the control; compared at different study time points. |
| at three months, at 12 months after the start of the intervention. |
| Mean change in quality of life (SIBDQ) | Mean change in quality of life (measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) 10-70 with higher scores indicating better quality of life) compared between the intervention and the control group; compared at different study time points. | at three months, at six months, and at 12 months after the start of the intervention. |
| Mean change in quality of life (EQ-5D VAS) | Mean change in quality of life (measured by EuroQoL 5 Dimension Visual Analog Score (EQ-5D VAS) 0-100 with higher scores indicating better quality of life) compared between the intervention and the control group; compared at different study time points. | at three months, at six months, and at 12 months after the start of the intervention. |
| Mean change in activity impairment | Mean change in activity impairment (measured by Work Activity and Productivity Impairment: Inflammatory Bowel Disease (WPAI:IBD) 0-100% with higher percentages indicating greater impairment) questionnaire) compared between the intervention and the control group; compared at different study time points. | at six months and at 12 months after the start of the intervention. |
| Mean Clinically Important Difference in fatigue (FACIT-F) | Percentage of participants who reached the Mean Clinically Important Difference (MCID) in the FACIT-F (MCID = 4) scores compared between the intervention and control group at different time points. | at three months, at six months, and at 12 months after the start of the intervention. |
| Mean Clinically Important Difference in quality of life (SIBDQ) | Percentage of participants who reached the Mean Clinically Important Difference (MCID) in the SIBDQ (MCID = 9) scores compared between the intervention and control group at different time points. | at three months, at six months, and at 12 months after the start of the intervention. |
| Mean Clinically Important Difference in quality of life (EQ-5D VAS). | Percentage of participants who reached the Mean Clinically Important Difference (MCID) in the EQ-5D VAS (MCID = 4.2) scores compared between the intervention and control group at different time points. | at three months, at six months, and at 12 months after the start of the intervention. |
| Mean Clinically Important Difference in activity impairment (WPAI:IBD) | Percentage of participants who reached the Mean Clinically Important Difference (MCID) in the WPAI:IBD (MCID= 7) scores compared between the intervention and control group at different time points. | at six months and at 12 months after the start of the intervention. |
| Mean change in dietary quality measured by Adjusted Mediterranean Diet Serving Score | Mean change in dietary quality (measured by Adjusted Mediterranean Diet Serving Score (Adjusted-MDSS) 0-17 with higher scores indicating better diet quality and adherence to the diet) compared between the intervention and the control group; compared at different study time points. | at three months, at six months, and at 12 months after the start of the intervention. |
| Mean change in physical exercise | Mean change in physical exercise (Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH) expressed in minutes of light/moderate/intensive exercise per week) compared between the intervention and the control group; compared at different study time points. | at three months, at six months, and at 12 months after the start of the intervention. |
| Mean change in perceived stress | Mean change in perceived stress (measured by Perceived Stress Scale (PSS) 0-40 with higher scores indicating higher perceived stress) compared between the intervention and the control group; compared at different study time points. | at three months, at six months, and at 12 months after the start of the intervention. |
| Mean change in coping with the illness | Mean change in coping (measured by Brief Illness Perception Questionnaire (B-IPQR) 0-10 with higher scores indicating a more threatening view of the illness) compared between the intervention and the control group; compared at different study time points. | at three months, at six months, and at 12 months after the start of the intervention. |
| Mean change in medical consumption | Mean change in medical consumption (measured by iMTA Medical Consumption Questionnaire (iMCQ) expressed as incurred costs per timepoint with higher costs indicating higher medical consumption) compared between the intervention and the control group; compared at different study time points. | at three months, at six months, and at 12 months after the start of the intervention. |
| Mean change in sleep quality | Mean change in sleep quality (measured by Pittsburgh Sleep Quality Index (PSQI) 0-21 with higher scores indicating worse sleep quality) compared between the intervention and the control group; compared at different study time points. | at three months, at six months, and at 12 months after the start of the intervention. |
| Correlation between fatigue and lifestyle (i.e., nutrition, exercise, sleep, stress) | Correlation between changes in lifestyle parameters and effect parameters (i.e., which part of the lifestyle intervention (e.g., physical activity or sleep quality) improved fatigue scores). | baseline, at six months and at 12 months after the start of the intervention. |
| Correlation between locus of control and lifestyle changes | Correlation between locus of control (Health Monitor questionnaire) at baseline and changes in lifestyle parameters and effect parameters. | baseline, at six months and at 12 months after the start of the intervention. |
| Cost-effectiveness of the intervention | Cost-effectiveness of the intervention based on Quality-Adjusted Life Years (QALY's) expressed as 1 (perfect health) to 0 (dead). | at six months and at 12 months after the start of the intervention. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D008722 | Methods |