IBD Inflammatory Bowel Disease
Conditions
Interventions
Intervention: a twelve-month multimodal lifestyle intervention provided by
Voeding Leeft. The lifestyle intervention is a multimodal program that teaches
participants the importance of an unprocesse
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: o Adults (>=18 years old); o Established IBD diagnosis (Crohn*s disease, Ulcerative colitis, or IBD-unclassified); o Biochemical remission (fecal calprotectin
Exclusion criteria
Exclusion criteria: o Documented comorbidities such as severe cardiac failure (classified as NYHA 3- 4), chronic kidney disease, myelodysplastic syndrome, Chronic Obstructive Pulmonary Disease (COPD), inherited metabolic diseases (e.g., phenylketonuria, mitochondrial or uric acid cycle pathologies), diabetes type 1; o Documented history of malignancy within the last three years before inclusion except for dermatological cancers such as basal cell carcinoma or squamous cell carcinoma; o Documented history of psychiatric diseases, eating disorders or addiction. Exception: patients with a history of depression and/or under treatment with antidepressants; however, at inclusion these patients must have a Hospital Anxiety Depression Scale (HADS) score 35 kg/m2; o Clinically significant anemia (Hb 100 fL and Hb >7.0 mmol/L for females and Hb >8.0 mmol/L for males) as a result of IBD-therapy related myelosuppression; o Vitamin B12 deficiency (defined as a concentration below the lower reference range expressed in units that are used by the laboratory where the test has been performed); o Folic acid deficiency (defined as a concentration below the lower reference range expressed in units that are used by the laboratory where the test has been performed); o Iron deficiency (defined as ferritin 2-week long hospitalization (in the last four weeks); o Unable to speak and understand Dutch language; o Participation in another study with lifestyle intervention or active consultation with a lifestyle coach on patient*s initiative; o Previous participation in the IBD-tailored program by Voeding Leeft.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: • How many patients, who undergo the multimodal lifestyle intervention, experience a reduction in fatigue compared with patients in the control group? | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective(s): • Does a multimodal lifestyle intervention improve quality of life in IBD patients with chronic fatigue? • How significant is the reduction in fatigue in patients that undergo the multimodal lifestyle intervention? • Does chronic fatigue change in the control group? What is the extent of the change in chronic fatigue? Does it differ from the change (and extent of it) compared with the intervention group? • How does a multimodal lifestyle intervention: o affect work productivity? o remission status (assessed using both symptom scores and fecal calprotectin)? o affect dietary quality, amount of physical exercise, sleep quality, perceived stress? o self-efficacy, coping strategy? o healthcare consumption? • Is the intervention cost-effective? | — |
Countries
Netherlands
Outcome results
None listed