Objective: to investigate if a multimodal lifestyle intervention reduces chronic fatigue and improves quality of life in patients with IBD.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective:
• How many patients, who undergo the multimodal lifestyle intervention,
experience a reduction in fatigue compared with patients in the control group?
Secondary outcome
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?
Background summary
Rationale: (chronic) fatigue is more prevalent in patients with Inflammatory
Bowel Disease (IBD) than in the general population. Chronic fatigue has
multiple causes, including immunologic and psychological factors, sleeping
problems, and alterations in the gut microbiome. In the Netherlands, there are
more than 90.000 IBD patients, of which 63.000 (70%) patients are in remission
at a given moment. Around 40% of patients in remission suffer from chronic
fatigue. It is the biggest impediment in patients* daily lives. Fatigue reduces
general well-being, quality of life (QoL), hampers social life, work
productivity and may limit career perspectives. Very few patients experience
resolution in fatigue, emphasizing the need for new interventions. Lifestyle
interventions can modulate the majority of fatigue-driving factors. Hence, we
hypothesize that a multimodal lifestyle intervention will reduce fatigue and
consequently improve quality of life in patients with IBD who suffer from
chronic fatigue.
Study objective
Objective: to investigate if a multimodal lifestyle intervention reduces
chronic fatigue and improves quality of life in patients with IBD.
Study design
Study design: a multicenter, open-label, non-randomized, controlled trial.
Intervention
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 unprocessed and diverse diet (comparable with
the Mediterranean diet), exercise, sleep, and stress reduction. It equips
participants with the knowledge and practical skills to change and maintain
their lifestyle permanently. The lifestyle intervention consists of three
digital plenary and four smaller group sessions. The sessions will be organized
over the course of six months. During the following six months participants can
attend additional facultative sessions, which are organized every six to twelve
weeks. These facultative sessions are aimed at encouragement of healthier
habits implementation and (peer) support.
Study burden and risks
The risk of (serious) adverse events is low. However, participants may not
tolerate certain food products and may suffer from abdominal pain, cramps
diarrhea, or constipation. The alteration of diet may lead to weight loss. In
patients with low to normal BMI, this may lead to an unwanted weight loss and
might bring some participants in the underweight category. Therefore, BMI <18.5
kg/m2 is defined as one of the studies exclusion criteria.
Albinusdreef 2
Leiden 2300RC
NL
Albinusdreef 2
Leiden 2300RC
NL
Listed location countries
Age
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.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | NCT05374967 |
CCMO | NL77752.058.21 |