The Effect of a Multimodal Lifestyle Intervention on Chronic Fatigue in Patients with Inflammatory Bowel Disease

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 106

Inclusion Criteria

o Adults (>=18 years old);
o Established IBD diagnosis (Crohn*s disease, Ulcerative colitis, or
IBD-unclassified);
o Biochemical remission (fecal calprotectin <=150 mcg/g);
o Clinically significant fatigue (VAS 4-8 out of 10);
o Willing and able to attend digital group sessions as a part of the
intervention.

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 <11 for the depression subscale;
o Documented familial hypercholesterolemia;
o Diabetes type 2 treated with insulin or other medications such as
sulfonylureas, glinides, alpha-glucosidase inhibitors, etc. The only exception
is biguanides*metformin.;
o BMI <18.5 or >35 kg/m2;
o Clinically significant anemia (Hb <7.0 mmol/l in females, Hb <8.0 mmol/l in
males) with the exception of marginal normocytic or macrocytic anemia (MCV >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 <30 µg/l);
o Vitamin D deficiency (<30 nmol/l);
o History of prior bariatric surgery or upper gastrointestinal surgery such as
Roux-Y reconstruction or (partial) gastrectomy due to benign or malignant
pathologies;
o Pregnancy or active breastfeeding;
o Unwillingness to follow the lifestyle program, i.e. people that do not want
to eat fish, vegans;
o Any change in systemic IBD-related medication in the last three months from
the start of the intervention. Changes in medication dose are allowed up to one
month before the start of the intervention. Exception: changing the route of
administration (e.g., switching from intravenous infliximab to subcutaneous
infliximab) or change in therapy due to side effects such as an allergic
reaction or cutaneous conditions.
o Recent major surgery, e.g. laparotomy in the last four weeks;
o Recent >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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective:<br /><br>• How many patients, who undergo the multimodal lifestyle intervention,<br /><br>experience a reduction in fatigue compared with patients in the control group?</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective(s):<br /><br>• Does a multimodal lifestyle intervention improve quality of life in IBD<br /><br>patients with chronic fatigue?<br /><br>• How significant is the reduction in fatigue in patients that undergo the<br /><br>multimodal lifestyle intervention?<br /><br>• Does chronic fatigue change in the control group? What is the extent of the<br /><br>change in chronic fatigue? Does it differ from the change (and extent of it)<br /><br>compared with the intervention group?<br /><br>• How does a multimodal lifestyle intervention:<br /><br>o affect work productivity?<br /><br>o remission status (assessed using both symptom scores and fecal calprotectin)?<br /><br>o affect dietary quality, amount of physical exercise, sleep quality, perceived<br /><br>stress?<br /><br>o self-efficacy, coping strategy?<br /><br>o healthcare consumption?<br /><br>• Is the intervention cost-effective?</p><br>