Quality of LifeNCT03884686
Promote Food. Improving Food-related Quality of Life in Inflammatory Bowel Disease
A study testing Web-based education resource in people with Quality of Life and Inflammatory Bowel Diseases, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Quality of Life, Inflammatory Bowel Diseases
- What is being tested?
- Web-based education resource
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Dec 2018to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
Jennifer Boston, R&D@gstt.nhs.uk
About this study
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.
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.
Read the 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.
- Conditions
- Quality of Life, Inflammatory Bowel Diseases
- Being tested
- Web-based education resource
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based education resourceOther
Intervention includes fact sheets, question and answers, short videos featuring patients and/or clinicians.
| Study group | Role | What they receive |
|---|---|---|
| Web-based intervention | Experimental | Patients allocated to intervention arm will have unlimited free access to a web-based education resource. Receives: Other: Web-based education resource |
| Usual care | No intervention | Patients allocated to usual care will receive all usual care and education opportunities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in food-related quality of life score as measured using validated questionnaire FR-QoL-29
Measured using validated questionnaire Food-Related Quality of Life (FR-QOL), consisting of 29 questions. Each question is answered on a 5 point Likert scale. The sum of which is the overall score. The minimum score is 29 (low food related quality of life) and maximum 145 (high food related quality of life). A score of less than 90 suggests poor food related quality of life.
Measured: 3 months
Secondary outcomes (3)
Change in United Kingdom inflammatory bowel disease questionnaire score
Measured using validated questionnaire the United Kingdom inflammatory bowel disease questionnaire (UK-IBDQ). This is a global disease specific quality of life questionnaire composed of 32 questions which are scored on a 4 point scale. Minimum score is 32 which indicates very poor quality of life and maximum score is 128 which is optimal quality of life.
Measured: 3 months
Change in disease activity index as measured using validated questionnaires
Measured using validated disease specific questionnaires Harvey Bradshaw Index (HBI) if patient has Crohn's disease. This questionnaire contains five questions. If the patient has ulcerative colitis the simple clinical colitis activity index (SCCAI) questionnaire will be used. It contains six questions. The minimum scores for both questionnaires is 0 and indicates disease is in remission. There are no maximum values but the higher the number the greater severe the disease activity.
Measured: 3 months
Change in presence of anxiety and depression score
Measured using validated questionnaire the hospital anxiety and depression score (HADS). The questionnaire contains 14 questions which are scored from 0 to 4. Seven questions relate to anxiety and seven relate to depression. An anxiety or depression sub-score of 0 suggests absence of anxiety or depression and a sub-score of eight or greater suggests borderline presence of anxiety or depression. A sub-score of 10 or more suggests presence of anxiety or depression.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start16 Dec 2018
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group will receive intervention and other group will receive usual care.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884686
- Sponsor's protocol ID
- IRAS 241127
- Status last verified
- Mar 2019
- First submitted
- 28 Jun 2018
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391Cox 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.
PubMed 36296976
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03884686
- Acronym / sponsor ID
- IRAS 241127
- Conditions
- Quality of Life, Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 16 Dec 2018 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group will receive intervention and other group will receive usual care.
| Arm | Type | Receives |
|---|---|---|
| Web-based intervention | Experimental | Other: Web-based education resourcePatients allocated to intervention arm will have unlimited free access to a web-based education resource. |
| Usual care | No intervention | –Patients allocated to usual care will receive all usual care and education opportunities. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- People diagnosed with either Crohn's disease or ulcerative colitis (collectively called inflammatory bowel disease) within the last 12 months
Key exclusion criteria (7 listed)
- People diagnosed with inflammatory bowel disease for more than 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based education resourceIntervention includes fact sheets, question and answers, short videos featuring patients and/or clinicians. | Other | Web-based intervention |
Primary outcome
Change in food-related quality of life score as measured using validated questionnaire FR-QoL-29
Time frame: 3 months
Measured using validated questionnaire Food-Related Quality of Life (FR-QOL), consisting of 29 questions. Each question is answered on a 5 point Likert scale. The sum of which is the overall score. The minimum score is 29 (low food related quality of life) and maximum 145 (high food related quality of life). A score of less than 90 suggests poor food related quality of life.
3 secondary outcomes
Change in United Kingdom inflammatory bowel disease questionnaire score
Time frame: 3 months
Change in disease activity index as measured using validated questionnaires
Time frame: 3 months
Change in presence of anxiety and depression score
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Derived from this study: PubMed 40243391Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
- Derived from this study: PubMed 36296976Cox 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based education resource in people with Quality of Life and Inflammatory Bowel Diseases, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevin Whelan (+442078483858, kevin.whelan@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in food-related quality of life score as measured using validated questionnaire FR-QoL-29 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03884686, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.