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

NCT03884686 | Unknown

• 1 other identifier: IRAS 241127
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (3)

• Change in United Kingdom inflammatory bowel disease questionnaire score

  3 months

• Change in disease activity index as measured using validated questionnaires

  3 months

• Change in presence of anxiety and depression score

  3 months

Study Arms (2)

Web-based intervention

EXPERIMENTAL

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

Other: Web-based education resource

Usual care

NO INTERVENTION

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

Interventions

Web-based education resource OTHER

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

Web-based intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

RECRUITING

Related Publications (2)

• 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.

  PMID: 40243391 DERIVED

• 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.

  PMID: 36296976 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Kevin Whelan

CONTACT

+442078483858; kevin.whelan@kcl.ac.uk

Reza Razavi

CONTACT

+442078486390; reza.razavi@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group will receive intervention and other group will receive usual care.

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: March 21, 2019
• Study Start: December 16, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)