NCT05374967

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
OTHER	Control group	The standard of care for patients with IBD suffering from chronic fatigue.

Timeline

• Start date: 2022-05-12
• Primary completion: 2024-03-01
• Completion: 2024-04-01
• First posted: 2022-05-16
• Last updated: 2023-08-01

Locations

1 site across 1 country: Netherlands