The primary objective is to assess the effect of a combined lifestyle intervention on the impact of disease on daily life as measured by the Inflammatory Bowel Disease Disability Index (IBD-DI) in patients with IBD. Secondary objectives are to…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is impact of disease on daily life as measured by the
IBD-DI, with lower scores representing more impact of disease.
Secondary outcome
Secondary parameters are fecal calprotectin, microbiome, clinical disease
activity measured by Harvey Bradshaw Index (HBI) in Crohn*s Disease and the
Simple Clinical Colitis Activity Index (SCCAI) in ulcerative colitis, quality
of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ),
fatigue as measured by the Inflammatory Bowel Disease Fatigue scale (IBD-F),
adherence to the lifestyle (combination of dietary intake and physical
activity), number of flare-ups and weight changes.
Background summary
Several studies suggest that diet and physical activity can help to maintain
remission and improve quality of life in patients with inflammatory bowel
disease (IBD). Currently, however, clear guidelines are lacking while many
patients are willing to adjust their lifestyle as add-on therapy in IBD
treatment.
Study objective
The primary objective is to assess the effect of a combined lifestyle
intervention on the impact of disease on daily life as measured by the
Inflammatory Bowel Disease Disability Index (IBD-DI) in patients with IBD.
Secondary objectives are to assess the effect on intestinal inflammation as
measured by fecal calprotectin, changes in microbiome, clinical disease
activity, quality of life, fatigue and number of flare-ups.
Study design
We propose to perform a 1-year intervention study consisting of a 3-month
introduction phase, a 3-month maintenance phase and 6-months of follow-up in
motivated patients. Participants will receive personal advice by a dietician
and a physical therapist to improve their diet and exercise level. These
advices will be supported by eHealth and an app with recipes.
Intervention
Personalized dietary advice is based on the Dutch Healthy Eating guidelines
with special emphasis on vegetables, fruits and grains. Tea, coffee, and water
are the preferred drinks. Red and processed meat, soft drinks and other
processed foods will be limited. Personalized physical activity advice is based
on the Dutch physical activity guidelines and includes exercise and activities
in daily life. If applicable smoking cessation will be advised.
Study burden and risks
This study provides an opportunity for patients who would like to follow a
combined lifestyle intervention, which is now lacking, for free. Subjects need
to visit Hospital Gelderse Vallei two times for measurements and consults.
Three times they are asked to collect two faecal samples. Additionally, they
need to fill in online questionnaires at baseline, after 5 weeks, 3 months, 6
months and 1 year. Since the investigational treatment of this study consists
of advices on commercially available food products and regular daily
activities, there are no direct risks for the subjects.
Willy Brandtlaan 10
Ede 6716RP
NL
Willy Brandtlaan 10
Ede 6716RP
NL
Listed location countries
Age
Inclusion criteria
- Diagnosis of Crohn*s disease or ulcerative colitis (total or left-sided
colitis) made by a gastroenterologist at least two years ago and histologically
proven
- Between 18 years and 70 years of age
- BMI <30 kg/m2
- In remission or mild disease activity that does not require immediate
medication change
- At least one flare-up in the past two years
- Signed informed consent
Exclusion criteria
- A total DHD-FFQ score of >140 points or a score of *9 points on each category
- Exercising at moderate intensity for 30 minutes or more 5 days per week or
more
- Use of prednisone
- Participation in another intervention study
- Not allowing to inform their general practitioner and gastroenterologist
about the participation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL70073.081.19 |
| Other | NL8267 |
| OMON | NL-OMON26291 |