Clinical trial NCT03884686: Promote Food. Improving Food-related Quality of Life in Inflammatory Bowel Disease
Official title: Promote Food. Improving Food-related Quality of Life in Patients With Inflammatory Bowel Disease: a Feasibility Study of a Web-base Educational Intervention.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Inflammatory Bowel Diseases
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2019-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will receive intervention and other group will receive usual care.
Primary purpose: OTHER

Brief summary: In previous studies, people with inflammatory bowel disease reported that the disease had a large impact on the psychosocial aspects of eating and drinking, and a high proportion of people felt excluded from social interactions that involved eating and drinking (for example religious, family) and there was considerable uncertainty around how eating will affect bowel function together with feelings of reduced autonomy and high levels of stress and anxiety. These patient experiences may lead to reduced food related quality of life.

This randomised control trial will examine the feasibility of using a web based intervention to improve the food related quality of life of people with inflammatory bowel disease. Fifty eligible participants will be randomised to receive either a 3-month website based intervention or usual care. The feasibility of study design, an estimate of the efficacy of the website intervention and patient experience of the intervention will be assessed after three months.

Patients will be recruited from inflammatory bowel disease outpatient clinics at Guy's and St Thomas' NHS Foundation Trust and Bart's Health NHS Trust in the United Kingdom.

Detailed description: The intervention. The web based intervention has been developed based on the outcomes of a previous study. The website is partially populated with several pages which contain educational material designed for patients newly diagnosed (within the last 12 months) with inflammatory bowel disease. The education material provides information related to different problems, short video clips of patients talking about their problems and ways of managing it, or a patient and health care professional consultation in relation to a particular problem, as well as question and answer fact sheets. In order to make the intervention relevant and acceptable to patients and health care professionals, both these groups were actively involved at each stage of the intervention development. During the 3 month intervention patients will have free and unlimited access to the website. Use of the website during the intervention phase will be monitored by the researcher and weekly emails will be sent to participants who do not engage in the intervention. Monthly emails will be sent to all intervention group patients to encourage engagement with the intervention.

Usual care. The patients randomised to usual care will have access to all usual care, including scheduled appointments and nurse-led telephone helpful. They will not have access to the intervention website.

Eligibility criteria: Inclusion Criteria:

* People diagnosed with either Crohn's disease or ulcerative colitis (collectively called inflammatory bowel disease) within the last 12 months

  * Proof of diagnosis (record of diagnostic endoscopy)
  * Aged 16 years and over
  * People who are experiencing food-related problems as a result of their inflammatory bowel disease (90 points or below, out of possible 145 measured by food related quality of life questionnaire)
  * People consuming a free oral diet
  * Sufficient command of written and spoken English to understand the study documentation and procedures
  * Access to internet and skills and ability to use electronic resources

Exclusion Criteria:

* People diagnosed with inflammatory bowel disease for more than 12 months

  * Diagnosis of indeterminate colitis
  * Hospitalised, nursing home or any other form of institutionalised living
  * Receiving intravenous nutrition, enteral nutrition or oral nutritional support which means that food intake is less than 50% of energy requirements (i.e. their energy from food is less than their energy intake from artificial nutritional support)
  * Diagnoses of other co-morbidities that may have impact on diet e.g. diabetes mellitus, coeliac disease, food allergies (not related to inflammatory bowel disease)
  * Pregnancy or less than 6 months post-partum
  * Inability to give informed consent (due to reduced mental capacity)

Primary outcomes:
measure: Change in food-related quality of life score as measured using validated questionnaire FR-QoL-29
timeFrame: 3 months
Secondary outcomes:
measure: Change in United Kingdom inflammatory bowel disease questionnaire score
timeFrame: 3 months
measure: Change in disease activity index as measured using validated questionnaires
timeFrame: 3 months
measure: Change in presence of anxiety and depression score
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
References:
citation: Cox SR, Czuber-Dochan W, Wall CL, Clarke H, Drysdale C, Lomer MC, Lindsay JO, Whelan K. Improving Food-Related Quality of Life in Inflammatory Bowel Disease through a Novel Web Resource: A Feasibility Randomised Controlled Trial. Nutrients. 2022 Oct 14;14(20):4292. doi: 10.3390/nu14204292.