Promote Food. Improving Food-related Quality of Life in Inflammatory Bowel Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-16

Study Completion Date

2019-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Quality of Life Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One group will receive intervention and other group will receive usual care.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Web-based intervention

Patients allocated to intervention arm will have unlimited free access to a web-based education resource.

Group Type EXPERIMENTAL

Web-based education resource

Intervention Type OTHER

Intervention includes fact sheets, question and answers, short videos featuring patients and/or clinicians.

Usual care

Patients allocated to usual care will receive all usual care and education opportunities.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Web-based education resource

Intervention includes fact sheets, question and answers, short videos featuring patients and/or clinicians.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No