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

Fatigue Clinical Trial

— Multi-IBD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05374967
• Other study ID #: NL77752.058.21
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 12, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: July 2023
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: April 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Behavioral:
• Lifestyle intervention: Live with IBD
A digital lifestyle intervention divided into two phases: An intensive phase lasting six months 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.

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center (LUMC)	Leiden

Sponsors (3)

Lead Sponsor	Collaborator
Leiden University Medical Center	Medical Center Haaglanden, Voeding Leeft

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	at three months, at 12 months after the start of the intervention.
Secondary	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.	at three months, at 12 months after the start of the intervention.
Secondary	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.	at three months, at six months, and at 12 months after the start of the intervention.
Secondary	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.	at three months, at six months, and at 12 months after the start of the intervention.
Secondary	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.	at six months and at 12 months after the start of the intervention.
Secondary	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.	at three months, at six months, and at 12 months after the start of the intervention.
Secondary	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.	at three months, at six months, and at 12 months after the start of the intervention.
Secondary	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.	at three months, at six months, and at 12 months after the start of the intervention.
Secondary	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.	at six months and at 12 months after the start of the intervention.
Secondary	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.	at three months, at six months, and at 12 months after the start of the intervention.
Secondary	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.	at three months, at six months, and at 12 months after the start of the intervention.
Secondary	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.	at three months, at six months, and at 12 months after the start of the intervention.
Secondary	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.	at three months, at six months, and at 12 months after the start of the intervention.
Secondary	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.	at three months, at six months, and at 12 months after the start of the intervention.
Secondary	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.	at three months, at six months, and at 12 months after the start of the intervention.
Secondary	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).	baseline, at six months and at 12 months after the start of the intervention.
Secondary	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.	baseline, at six months and at 12 months after the start of the intervention.
Secondary	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).	at six months and at 12 months after the start of the intervention.