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

NCT05374967 | Unknown

• 1 other identifier: NL77752.058.21
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

IBD; Crohn's disease; Ulcerative colitis; Inflammatory Bowel Disease; Fatigue; Lifestyle

Outcome Measures

Primary Outcomes (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.

  Six months after starting the intervention

Secondary Outcomes (18)

• Mean change in fatigue (FACIT-F)

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

• Mean change in fatigue (fatigue VAS)

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

• Mean change in quality of life (SIBDQ)

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

• Mean change in quality of life (EQ-5D VAS)

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

• Mean change in activity impairment

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

Study Arms (2)

Control group

OTHER

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

Other: Control group

Lifestyle intervention

EXPERIMENTAL

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.

Behavioral: Lifestyle intervention: Live with IBD

Interventions

Lifestyle intervention: Live with IBD 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.

Also known as: Leef! met IBD

Lifestyle intervention

Control group OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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
• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Medical Center Haaglanden: collaborator
• Voeding Leeft: collaborator

Study Sites (1)

Leiden University Medical Center (LUMC)

Leiden, 2333ZA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 40243391 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Fatigue; Crohn Disease; Colitis, Ulcerative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• P.W.J. Maljaars, MD, PhD

  LUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: May 16, 2022
• Study Start: May 12, 2022
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)