ADAPT: Acceptability of online dietary assessment of irritable bowel syndrome (IBS) patients in clinical practice

ISRCTN	ISRCTN12932938
DOI	https://doi.org/10.1186/ISRCTN12932938
IRAS number	305797
Secondary identifying numbers	IRAS 305797, CPMS 51905

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Study website

Contact information

Dr Linda Griep
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
Email	linda.oudegriep@mrc-epid.cam.ac.uk

Study information

Study design	Parallel randomized controlled intervention study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient 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	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.
Secondary outcome measures	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. 2. Quality of dietetic practice - measured by Satisfaction, acceptability and Quality of Care questionnaire at the discharge timepoint. Also measured using information from CUH electronic medical notes at at baseline, monthly, within 2 weeks pre-dietetic appointment, discharge and end of study time points. 3. Response rates and acceptability of dietary assessment methods - measured by Satisfaction, acceptability and Quality of Care questionnaire at the discharge timepoint. 4. Quality of life (IBS specific) - measured by IBS Quality of Life questionnaire at baseline, discharge and end of study timepoints. 5. Dietetic consultation time (for one-to-one consultations only) - measured using information from CUH electronic medical notes at at baseline, monthly, within 2 weeks pre-dietetic appointment, discharge and end of study time points. 6. Frequency of follow-up dietetic consultations (for one-to-one consultations only) - measured using information from CUH electronic medical notes at at baseline, monthly, within 2 weeks pre-dietetic appointment, discharge and end of study time points.
Overall study start date	07/12/2021
Completion date	31/07/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	80 - 100
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

England
United Kingdom

Study participating centre

Intestinal Failure and Gastroenterology Clinic, Addenbrookes Hospital

Department of Nutrition & Dietetics
Box 119
Cambridge University Hospitals NHS Foundation Trust
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust
Hospital/treatment centre

Research & Development Department
Cambridge University Hospitals NHS Foundation Trust
Addenbrooke's Hospital Box 277 (level 4 S block)
Cambridge
CB2 0QQ
England
United Kingdom

Phone	+44 (0)1223 349810
Email	research@addenbrookes.nhs.uk
Website	https://www.cuh.nhs.uk/our-services/addenbrookes-clinical-research-centre/
"ROR"	https://ror.org/04v54gj93

University of Cambridge
University/education

School of Clinical Medicine, Box 111
Cambridge Biomedical Campus
Cambridge
CB2 0SP
England
United Kingdom

Phone	+44 (0)1223 769291
Email	research_governance@medschl.cam.ac.uk
Website	https://researchgovernance.medschl.cam.ac.uk/
"ROR"	https://ror.org/013meh722

Funders

Funder type

Government

NIHR Cambridge Biomedical Research Centre
Government organisation / Local government

Alternative name(s): Cambridge Biomedical Research Centre, NIHR Cambridge BRC, National Institute for Health Research Cambridge Biomedical Research Centre
Location: United Kingdom

Results and Publications

Intention to publish date	30/12/2024
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in peer-reviewed high-impact scientific journals.
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
Protocol file	version 4	19/07/2023	29/07/2025	No	No

Additional files

ISRCTN12932938_PROTOCOL_V4_19Jul2023.pdf

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