Gastroenterology SurgeryEarly Phase 1NCT04758559
Usability of myfood24 in Clinical Populations
A Early Phase 1 study testing myfood24 in people with Gastroenterology Surgery and Colorectal Surgery, run by University of Leeds at 2 sites in United Kingdom.
Trial summary
Many patients would benefit from dietary/nutritional support to better manage their conditions but evaluating current intake in relation to personal targets is labour-intensive and often does not feature as part of clinical consultations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroenterology Surgery, Colorectal Surgery, Weight Loss
- What is being tested?
- myfood24
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jan 2020to 31 May 2021
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to use a smartphone or tablet
- Have regular access to the internet
- Aged 18 years or over
- Not receiving palliative treatment for their condition
- No pre-existing condition, eg. diabetes which requires a specific diet or eating disorder
- No food allergies
- Be receiving ongoing gastrointestinal surgery or weight management treatment
- Be able to read and understand English
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Gastroenterology surgery
Leeds, W. Yorks
Tier 3 Weight Management Clinic
York
About this study
Many patients would benefit from dietary/nutritional support to better manage their conditions but evaluating current intake in relation to personal targets is labour-intensive and often does not feature as part of clinical consultations.
Primary objective: test usability and acceptability of 'myfood24 Health' for monitoring dietary intake in a group of patients.
Read more
Recruit 60 gastroenterology surgery patient (Leeds) and 60 Tier 3 Weight Management patients (30 Leeds/ 30 York).
Randomise to 3 groups
- usual care
- myfood24Health
- myfood24Health plus personalised feedback 'diet optimisation engine' which suggests changes to amounts or types of foods
During a 2-month follow-up, patients in group 2 or 3 will be asked to record daily diet in myfood24, including weekend and weekdays and use it a minimum of 4 times.
HCPs will be able to review diet/nutrients for group 2 and 3 patients and can support dietary change or nutritional goals, as part of patients' ongoing clinical management, during existing scheduled clinic visits (N.B. not all participants will have a scheduled clinic appointment during the study).
2 months after recruitment, all participants will receive a link to an online feedback questionnaire.
At end of study, HPCs will be invited to provide feedback during a 30 minute interview.
Read the detailed description
See published results at https://www.mdpi.com/2072-6643/14/9/1768
- Being tested
- myfood24, usual care
- Keywords
- diet monitoring, diet optimisation, nutrition
- Medical subject headings
- Weight Loss, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myfood24Other
Also called myfood24 + diet optimisation
An app to support monitoring of food and nutrient intake using robust validated methodology.
usual careOther
Patients will receive standard advice as provided by the clinical team, this may or may not include nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Placebo comparator | Patients receive usual care concerning dietary advice. Receives: Other: usual care |
| myfood24 | Experimental | Patients receive myfood24 a new online app to support tracking of food and nutrient intakes, and allows patients and healthcare professionals to communicate, seeing results of intakes to promote healthy dietary behaviour changes. Receives: Other: myfood24 |
| myfood24 + diet optimisation | Experimental | Personalised feedback. Patients use myfood24 with an additional feature of new technology providing guidance of how to optimise their diets against targets, using information they provide about current intakes. Receives: Other: myfood24 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of myfood24
System usability scale 1 to 10. HIgher score is better. Online survey.
Measured: 6 weeks
Secondary outcomes (3)
Ability of myfood24+ diet optimisation to change diet to meet diet targets
myfood24 app allows the healthcare professional to set personalised nutrition targets for the patient. Nutrient intakes will be measured in myfood24 and myfood24+ diet optimisation groups. We will explore differences in nutrient intakes between the groups. Nutrients measured will be daily intake average for energy (kcal), protein (g), fat (g), carbohydrate (g), fibre (g) sodium (g).
Measured: 6 weeks
Response rate
response rates prior to undertaking a full scale randomised controlled trial
Measured: 6 weeks
Correlation between diet and routine measure of body mass index
To explore correlations between mean energy intake (kcal/day) as recorded by multiple online 24-hour dietary recalls, with routine BMI in kg/m^2
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Jan 2020
- Primary completion31 May 2021
- Study completion31 May 2021
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 Gastroenterology SurgeryStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised into: Usual care; myfood24; myfood24 with automated suggestions
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Dietary Assessment Ltd
- Responsible party
- Principal investigator, Janet Cade, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758559
- Sponsor's protocol ID
- IRAS 266347
- Status last verified
- Dec 2024
- First submitted
- 9 Feb 2021
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wark PA, Hardie LJ, Frost GS, Alwan NA, Carter M, Elliott P, Ford HE, Hancock N, Morris MA, Mulla UZ, Noorwali EA, Petropoulou K, Murphy D, Potter GDM, Riboli E, Greenwood DC, Cade JE. Validity of an online 24-h recall tool (myfood24) for dietary assessment in population studies: comparison with biomarkers and standard interviews. BMC Med. 2018 Aug 9;16(1):136. doi: 10.1186/s12916-018-1113-8.
PubMed 30089491Carter MC, Albar SA, Morris MA, Mulla UZ, Hancock N, Evans CE, Alwan NA, Greenwood DC, Hardie LJ, Frost GS, Wark PA, Cade JE; myfood24 Consortium. Development of a UK Online 24-h Dietary Assessment Tool: myfood24. Nutrients. 2015 May 27;7(6):4016-32. doi: 10.3390/nu7064016.
PubMed 26024292
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability of myfood24 in Clinical Populations
- ClinicalTrials.gov ID
- NCT04758559
- Acronym / sponsor ID
- IRAS 266347
- Keywords
- diet monitoring, diet optimisation, nutrition
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Dietary Assessment Ltd
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 17 Feb 2021 (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.
Many patients would benefit from dietary/nutritional support to better manage their conditions but evaluating current intake in relation to personal targets is labour-intensive and often does not feature as part of clinical consultations.
Primary objective: test usability and acceptability of 'myfood24 Health' for monitoring dietary intake in a group of patients.
Recruit 60 gastroenterology surgery patient (Leeds) and 60 Tier 3 Weight Management patients (30 Leeds/ 30 York).
Randomise to 3 groups
- usual care
- myfood24Health
- myfood24Health plus personalised feedback 'diet optimisation engine' which suggests changes to amounts or types of foods
During a 2-month follow-up, patients in group 2 or 3 will be asked to record daily diet in myfood24, including weekend and weekdays and use it a minimum of 4 times.
HCPs will be able to review diet/nutrients for group 2 and 3 patients and can support dietary change or nutritional goals, as part of patients' ongoing clinical management, during existing scheduled clinic visits (N.B. not all participants will have a scheduled clinic appointment during the study).
2 months after recruitment, all participants will receive a link to an online feedback questionnaire.
At end of study, HPCs will be invited to provide feedback during a 30 minute interview.
Detailed description
See published results at https://www.mdpi.com/2072-6643/14/9/1768
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised into: Usual care; myfood24; myfood24 with automated suggestions
| Arm | Type | Receives |
|---|---|---|
| Usual care | Placebo comparator | Other: usual carePatients receive usual care concerning dietary advice. |
| myfood24 | Experimental | Other: myfood24Patients receive myfood24 a new online app to support tracking of food and nutrient intakes, and allows patients and healthcare professionals to communicate, seeing results of intakes to promote healthy dietary behaviour changes. |
| myfood24 + diet optimisation | Experimental | Other: myfood24Personalised feedback. Patients use myfood24 with an additional feature of new technology providing guidance of how to optimise their diets against targets, using information they provide about current intakes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to use a smartphone or tablet
- Have regular access to the internet
- Aged 18 years or over
- Not receiving palliative treatment for their condition
- No pre-existing condition, eg. diabetes which requires a specific diet or eating disorder
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| myfood24Also: myfood24 + diet optimisationAn app to support monitoring of food and nutrient intake using robust validated methodology. | Other | myfood24, myfood24 + diet optimisation |
| usual carePatients will receive standard advice as provided by the clinical team, this may or may not include nutrition. | Other | Usual care |
Primary outcome
Usability of myfood24
Time frame: 6 weeks
System usability scale 1 to 10. HIgher score is better. Online survey.
3 secondary outcomes
Ability of myfood24+ diet optimisation to change diet to meet diet targets
Time frame: 6 weeks
Response rate
Time frame: 6 weeks
Correlation between diet and routine measure of body mass index
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Results publication: PubMed 30089491Wark PA, Hardie LJ, Frost GS, Alwan NA, Carter M, Elliott P, Ford HE, Hancock N, Morris MA, Mulla UZ, Noorwali EA, Petropoulou K, Murphy D, Potter GDM, Riboli E, Greenwood DC, Cade JE. Validity of an online 24-h recall tool (myfood24) for dietary assessment in population studies: comparison with biomarkers and standard interviews. BMC Med. 2018 Aug 9;16(1):136. doi: 10.1186/s12916-018-1113-8.
- Results publication: PubMed 26024292Carter MC, Albar SA, Morris MA, Mulla UZ, Hancock N, Evans CE, Alwan NA, Greenwood DC, Hardie LJ, Frost GS, Wark PA, Cade JE; myfood24 Consortium. Development of a UK Online 24-h Dietary Assessment Tool: myfood24. Nutrients. 2015 May 27;7(6):4016-32. doi: 10.3390/nu7064016.
- website of myfood24 toolLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing myfood24 in people with Gastroenterology Surgery and Colorectal Surgery, run by University of Leeds at 2 sites 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 8 inclusion and 1 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: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of myfood24 (time frame: 6 weeks). 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 NCT04758559, 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 6 Dec 2024.