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

NCT ID: NCT05374967

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-12
• Study Completion Date: 2024-04-01

Brief 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). 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).

Conditions

Inflammatory Bowel Diseases; Fatigue

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

The control group will receive the current standard of care: an informational brochure on how to cope with fatigue.

Group Type: OTHER

Control group

Intervention Type: OTHER

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

Lifestyle intervention

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.

Group Type: EXPERIMENTAL

Lifestyle intervention: Live with IBD

Intervention Type: BEHAVIORAL

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.

Interventions

Lifestyle intervention: Live with 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.

Intervention Type: BEHAVIORAL

Control group

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

Intervention Type: OTHER

Other Intervention Names

Leef! met IBD

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Center Haaglanden

OTHER

Sponsor Role: collaborator

Voeding Leeft

UNKNOWN

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Pieter Maljaars

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

P.W.J. Maljaars, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

LUMC

Locations

Leiden University Medical Center (LUMC)

Leiden, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 40243391 (View on PubMed)

Other Identifiers

NL77752.058.21

Identifier Type: -

Identifier Source: org_study_id