ADAPT: Acceptability of online dietary assessment of irritable bowel syndrome (IBS) patients in clinical practice
| ISRCTN | ISRCTN12932938 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12932938 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 305797 |
| Protocol serial number | IRAS 305797, CPMS 51905 |
| Sponsors | Cambridge University Hospitals NHS Foundation Trust, University of Cambridge |
| Funder | NIHR Cambridge Biomedical Research Centre |
- Submission date
- 07/12/2021
- Registration date
- 06/01/2022
- Last edited
- 04/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Detailed dietary assessment during routine clinical dietetic care to provide personalised advice irritable bowel syndrome (IBS) symptom improvement is challenging. Clinical practice barriers include competing demands, lack of clinical time, dietary and disease complexities, and the rising incidence and thus clinical pressure. This research project aims to evaluate the feasibility, acceptability and effectiveness of using a web-based 24-hr dietary recall system (Intake24) for personalised dietary advice versus usual dietetic clinical care of IBS patients.
Who can participate?
Newly admitted patients (male and female) older than 18 years of age, who meet the ROMEIV criteria for IBS diagnosis according to the National Institute of Health and Care Excellence (NICE) guidelines will be invited to participate.
What does the study involve?
Patients will be randomly allocated (1:1) to dietetic practice using web-based 24-hr dietary recalls (Intake24) for personalised dietary advice or routine dietetic care. Participants will be followed up for 6 months and will be invited to complete online questionnaires on outcome measures including IBS symptom severity and relief, quality of life, satisfaction and acceptability of dietary assessment method, and quality of dietetic care.
What are the possible benefits and risks of taking part?
For participants in the Intake24 arm, they will receive tailored dietary feedback from their Intake24 dietary assessment. We do not foresee any adverse events over and above those associated with everyday life and routine health care that could be attributable to the intervention. During the study, participants will be asked to complete the 24hr Dietary recall and study questionnaires multiple times, this could be seen as an inconvenience/burden to the participants.
Where is the study run from?
Cambridge Epidemiology Trials Unit based at the MRC Epidemiology Unit, University of Cambridge (UK)
When is the study starting and how long is it expected to run for?
December 2021 to July 2024
Who is funding the study?
NIHR Cambridge Biomedical Research Centre (UK)
Who is the main contact?
Dr Linda Oude Griep - Chief Investigator
linda.oudegriep@mrc-epid.cam.ac.uk
Contact information
Scientific, Principal investigator
MRC Epidemiology Unit
University of Cambridge
Institute of Metabolic Science, Box 285
Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
 ORCID ID |
0000-0001-7697-7473 |
|---|---|
| Phone | +44 (0)1223 330315 |
| linda.oudegriep@mrc-epid.cam.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Parallel randomized controlled intervention study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled trial to evaluate the feasibility of web-based dietary assessment for improved personalised dietary advice in routine clinical dietetic practice of irritable bowel syndrome (IBS) patients |
| Study acronym | ADAPT |
| Study objectives | This research project aims to establish the feasibility, acceptability and effectiveness of using a web-based 24-hr dietary recall system (Intake24) for improved personalised dietary advice versus usual dietetic clinical care of IBS patients. |
| Ethics approval(s) | Approved 15/03/2022, East of England - Cambridgeshire and Hertfordshire Research Ethics Committee (Meeting held by video-conference via Zoom; +44 (0)2071048096; cambsandherts.rec@hra.nhs.uk), ref: 22/EE/0038 |
| Health condition(s) or problem(s) studied | Irritable bowel syndrome (IBS) |
| Intervention | A sample between 80 and 100 patients diagnosed with IBS will be randomly allocated (1:1) to web-based 24-hour dietary recalls or routine dietetic practice (dietary history interview method) and followed for 6 months. Patients allocated to the intervention will be invited to complete at least two 24-hour dietary recalls prior to the dietetic appointment (one-to-one consultations or group sessions). This will provide 1) quantified online dietary feedback upon completion of each recall for the patient’s review, and 2) upload of detailed dietary results report to the patient’s electronic medical notes for the dietitians’ review to tailor dietary advice to patients during one-to-one consultations. Current routine dietetic practice uses dietician-led diet history interviews during one-to-one consultations or no dietary assessment for group sessions. All IBS patients enrolled in the study will be invited to complete web-based 24-hour dietary recalls prior to initial dietetic consultation and at the end of the study (6 months). |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
IBS adequate relief and symptom severity score measured by IBS symptoms questionnaire at baseline, monthly, within 2 weeks pre-dietetic appointment, discharge and end of study time points. |
| Key secondary outcome measure(s) |
1. Adherence to dietetic advice - measured by IBS symptoms questionnaire at baseline, monthly, within 2 weeks pre-dietetic appointment, discharge and end of study time points. |
| Completion date | 31/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Newly admitted patients older than 18 years 2. Meet the ROME IV criteria for IBS diagnosis according to the National Institute for Health and Care Excellence (NICE) guidelines |
| Key exclusion criteria | 1. Younger than 18 years 2. Co-existing gastrointestinal disease (e.g. inflammatory bowel disease, celiac disease) or eating disorder 3. No availability or access to a computer, tablet, or internet 4. Insufficient English language proficiency 5. Unable to give informed consent |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Box 119
Cambridge University Hospitals NHS Foundation Trust
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Data requests should be made to Dr Linda Oude Griep at linda.oudegriep@mrc-epid.cam.ac.uk. Data would be fully anonymised and only shared with bona fide researchers attached to an academic/research institution. Participants will have given consent for their data to be shared anonymously with other researchers. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 4 | 19/07/2023 | 29/07/2025 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN12932938_PROTOCOL_V4_19Jul2023.pdf
- Protocol file
Editorial Notes
04/08/2025: The date of final enrolment was changed from 31/08/2023 to 31/12/2023.
30/07/2025: Total final enrolment added.
29/07/2025: Protocol uploaded.
05/02/2024: The following changes have been made:
1. The intention to publish date was changed from 30/12/2023 to 30/12/2024.
2. The overall study end date was changed from 16/01/2024 to 31/07/2024.
16/06/2023: The following changes have been made:
1. The overall trial end date has been changed from 30/10/2023 to 16/01/2024 and the plain English summary updated accordingly.
2. The recruitment end date has been changed from 30/06/2023 to 31/08/2023.
28/11/2022: The following changes have been made:
1. The overall trial end date has been changed from 30/12/2022 to 30/10/2023 and the plain English summary updated accordingly.
2. The recruitment start date has been changed from 28/03/2022 to 01/06/2022.
3. The recruitment end date has been changed from 30/10/2022 to 30/06/2023.
17/03/2022: The following changes have been made:
1. The recruitment start date has been changed from 14/03/2022 to 28/03/2022.
2. The ethics approval has been added.
17/02/2022: The following changes have been made:
1. The recruitment start date has been changed from 14/02/2022 to 14/03/2022.
2. The recruitment end date has been changed from 30/09/2022 to 30/10/2022.
01/02/2022: Internal review.
06/01/2022: Trial's existence confirmed by University of Cambridge
