AzTrials
AzTrials

Inflammatory Bowel DiseasesMulti-IBDNCT05374967

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

A study testing Lifestyle intervention: Live with IBD in people with Inflammatory Bowel Diseases and Fatigue, run by Leiden University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Chronic fatigue is highly prevalent in patients with conditions characterized by chronic inflammation of the gastrointestinal tract, also known as Inflammatory Bowel Disease (IBD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Inflammatory Bowel Diseases, Fatigue
What is being tested?
Lifestyle intervention: Live with IBD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteNetherlands
Study dates
12 May 2022to 1 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults (≥18 years old)
  • Established IBD diagnosis (Crohn's disease, Ulcerative colitis, or IBD-unclassified)
  • Biochemical remission (fecal calprotectin ≤150 mcg/g)
  • Clinically significant fatigue (visual analog score 4-8 out of 10)
  • Willing and able to attend digital group sessions as a part of the intervention

Who cannot join

  • 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
  • Documented history of malignancy within the last three years before inclusion except for dermatological cancers such as basal cell carcinoma or squamous cell carcinoma
  • 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 the patients must have a Hospital Anxiety Depression Scale (HADS) score <11 for the depression subscale
  • Documented familial hypercholesterolemia
  • Diabetes type 2 treated with insulin or other medications such as sulfonylureas, glinides, alpha-glucosidase inhibitors, etc. The only exception is biguanides-metformin
  • BMI <18.5 or >35 kg/m2
Show all 19Show fewer
  • 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
  • Vitamin B12 or folic acid deficiency
  • Iron deficiency (defined as ferritin <30 μg/l)
  • Vitamin D deficiency (<30 nmol/l)
  • History of prior bariatric surgery or upper gastrointestinal surgery such as Roux-Y reconstruction or (partial) gastrectomy due to benign or malignant pathologies
  • Pregnancy or active breastfeeding
  • Unwillingness to follow the lifestyle program, i.e. people that do not want to eat fish, vegans
  • Any change in IBD-related systemic medication within the last three months of intervention. Changes in medication dose are allowed up to 1 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.
  • Recent major surgery, e.g. laparotomy in the last four weeks
  • Extended hospitalization (a >2-week admission) within four weeks before inclusion
  • Unable to speak and understand Dutch language
  • Participation in another study with lifestyle intervention or active consultation with a lifestyle coach on patient's initiative
  • Previous participation in the IBD-tailored program by Voeding Leeft

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Leiden University Medical Center (LUMC)

    Leiden, 2333ZA

Other trials in Netherlands

About this study

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).

Being tested
Lifestyle intervention: Live with IBD, Control group
Keywords
IBD, Crohn's disease, Ulcerative colitis, Inflammatory Bowel Disease, Fatigue, Lifestyle
Medical subject headings
Inflammatory Bowel Diseases, Fatigue, Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle intervention: Live with IBDBehavioural

    Also called Leef! met IBD

    A digital lifestyle intervention divided into two phases:

    1. An intensive phase lasting six months
    2. a facultative phase lasting six months

    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.

  • Control groupOther

    The standard of care for patients with IBD suffering from chronic fatigue.

Study groups in NCT05374967
Study groupRoleWhat they receive
Control groupOtherThe control group will receive the current standard of care: an informational brochure on how to cope with fatigue.
Receives: Other: Control group
Lifestyle interventionExperimentalParticipants 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.
Receives: Behavioral: Lifestyle intervention: Live with IBD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Six months after starting the intervention

Secondary outcomes (18)

  1. 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.

    Measured: at three months, at 12 months after the start of the intervention.

  2. Mean change in fatigue (fatigue VAS)

    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.

    Measured: at three months, at 12 months after the start of the intervention.

  3. 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.

    Measured: at three months, at six months, and at 12 months after the start of the intervention.

  4. 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.

    Measured: at three months, at six months, and at 12 months after the start of the intervention.

  5. 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.

    Measured: at six months and at 12 months after the start of the intervention.

  6. 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.

    Measured: at three months, at six months, and at 12 months after the start of the intervention.

  7. 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.

    Measured: at three months, at six months, and at 12 months after the start of the intervention.

  8. 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.

    Measured: at three months, at six months, and at 12 months after the start of the intervention.

  9. 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.

    Measured: at six months and at 12 months after the start of the intervention.

  10. 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.

    Measured: at three months, at six months, and at 12 months after the start of the intervention.

  11. 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.

    Measured: at three months, at six months, and at 12 months after the start of the intervention.

  12. 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.

    Measured: at three months, at six months, and at 12 months after the start of the intervention.

  13. 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.

    Measured: at three months, at six months, and at 12 months after the start of the intervention.

  14. 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.

    Measured: at three months, at six months, and at 12 months after the start of the intervention.

  15. 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.

    Measured: at three months, at six months, and at 12 months after the start of the intervention.

  16. 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).

    Measured: baseline, at six months and at 12 months after the start of the intervention.

  17. 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.

    Measured: baseline, at six months and at 12 months after the start of the intervention.

  18. 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).

    Measured: at six months and at 12 months after the start of the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2022
  2. Study start12 May 2022
  3. Primary completion1 Mar 2024 (estimated)
  4. Study completion1 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05374967
Sponsor's protocol ID
NL77752.058.21
Acronym
Multi-IBD
Status last verified
Jul 2023
First submitted
7 Apr 2022
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40243391

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle intervention: Live with IBD in people with Inflammatory Bowel Diseases and Fatigue, run by Leiden University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue at six months (time frame: Six months after starting the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05374967, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in