Nutritional DisordersNCT04039282
Exploring the Use of myfood24 (an Online Nutritional Assessment Tool) in Clinical Dietetic Practice
A study testing myfood24 in people with Nutritional Disorders and Nutrition Therapy, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Dietary assessment is a key component of the dietetic care process. Assessments usually take place within dietetic consultations using methods such as 24-hour recall and paper food diaries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutritional Disorders, Nutrition Therapy, Food Habits
- What is being tested?
- myfood24
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jul 2019to 31 Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 18 years
- Referred to the STH Dietetic Department
- Willing and able to attend a dietetic out-patient appointment
- Can read and understand English
- Have access to the internet
- Willing to engage in technology as part of their care
- Have or willing to obtain their own email address
Who cannot join
- Under 18 years
- Unable or unwilling to attend a dietetic out-patient appointment
- Unable to read and understand English
- No access to the internet
- Unwilling to engage in technology as part of their care
- Does not have or unwilling to obtain their own email address
Trial locations and contacts
1 site in 1 country.
About this study
Dietary assessment is a key component of the dietetic care process. Assessments usually take place within dietetic consultations using methods such as 24-hour recall and paper food diaries. This study will examine the feasibility of using an online dietary assessment tool, myfood24 as an alternative to current dietary assessment practices and explore the barriers and facilitators to its use within dietetic clinical practice. This will be a mixed method study using questionnaires and semi structures interviews with both dietitians and patients. Dietitians, and patients with a range of clinical conditions referred to an NHS Dietetic Service, will be recruited. Patients will be asked to trial the system to record their food intake prior to their dietetic appointment. This data will then be used for the dietary assessment within the consultation. Following this, patients and dietitians will be interviewed about their experiences. Quantitative data will be statistically analysed, and thematic analysis will be used to analyse qualitative data.
- Conditions
- Nutritional Disorders, Nutrition Therapy, Food Habits
- Being tested
- myfood24
- Keywords
- nutrition, dietary recall
- Medical subject headings
- Nutrition Disorders, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myfood24Device
online website for dietary analysis
| Study group | Role | What they receive |
|---|---|---|
| Patient Participant | Other | Patients will be asked to complete an 3 days worth of an online dietary recall prior to their out patient appointment with the dietitian Receives: Device: myfood24 |
| Dietitian Participant | Other | The Dietitian will be asked to review the patients completed dietary recalls prior to the patient attending their out patient appointment. Receives: Device: myfood24 |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability
System usability score is generated using system usability scale - a validated questionnaire.
Measured: After patients have used the system. Approximately 4 to 8 weeks after baseline.
Secondary outcomes (2)
Patient Activation
Patient activation score will be generated using Patient Activation Measure (PAM) a validated questionnaire.
Measured: Baseline and end of intervention. (approximately 3 months from baseline)
Acceptability of using the system as part of dietetic care
This will be generated using (I) Acceptability questionnaire for patients using a non-validated questionnaire and (2) Through participant interviews.
Measured: The acceptability questionnaire and interviews will be completed at the end of the intervention.(approx 3 months from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start22 Jul 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional DisordersStudies 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield, British Dietetic Association, Dietary Assessment Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039282
- Sponsor's protocol ID
- STH19780
- Status last verified
- Sep 2019
- First submitted
- 26 Jul 2019
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Use of myfood24 (an Online Nutritional Assessment Tool) in Clinical Dietetic Practice
- ClinicalTrials.gov ID
- NCT04039282
- Acronym / sponsor ID
- STH19780
- Conditions
- Nutritional Disorders, Nutrition Therapy, Food Habits
- Keywords
- nutrition, dietary recall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield, British Dietetic Association, Dietary Assessment Ltd
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 31 Jul 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.
Dietary assessment is a key component of the dietetic care process. Assessments usually take place within dietetic consultations using methods such as 24-hour recall and paper food diaries. This study will examine the feasibility of using an online dietary assessment tool, myfood24 as an alternative to current dietary assessment practices and explore the barriers and facilitators to its use within dietetic clinical practice. This will be a mixed method study using questionnaires and semi structures interviews with both dietitians and patients. Dietitians, and patients with a range of clinical conditions referred to an NHS Dietetic Service, will be recruited. Patients will be asked to trial the system to record their food intake prior to their dietetic appointment. This data will then be used for the dietary assessment within the consultation. Following this, patients and dietitians will be interviewed about their experiences. Quantitative data will be statistically analysed, and thematic analysis will be used to analyse qualitative data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Participant | Other | Device: myfood24Patients will be asked to complete an 3 days worth of an online dietary recall prior to their out patient appointment with the dietitian |
| Dietitian Participant | Other | Device: myfood24The Dietitian will be asked to review the patients completed dietary recalls prior to the patient attending their out patient appointment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged over 18 years
- Referred to the STH Dietetic Department
- Willing and able to attend a dietetic out-patient appointment
- Can read and understand English
- Have access to the internet
Key exclusion criteria (6 listed)
- Under 18 years
- Unable or unwilling to attend a dietetic out-patient appointment
- Unable to read and understand English
- No access to the internet
- Unwilling to engage in technology as part of their care
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 |
|---|---|---|
| myfood24online website for dietary analysis | Device | Dietitian Participant, Patient Participant |
Primary outcome
System Usability
Time frame: After patients have used the system. Approximately 4 to 8 weeks after baseline.
System usability score is generated using system usability scale - a validated questionnaire.
2 secondary outcomes
Patient Activation
Time frame: Baseline and end of intervention. (approximately 3 months from baseline)
Acceptability of using the system as part of dietetic care
Time frame: The acceptability questionnaire and interviews will be completed at the end of the intervention.(approx 3 months from baseline)
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 17 Mar 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myfood24 in people with Nutritional Disorders and Nutrition Therapy, run by Sheffield Teaching Hospitals 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 6 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 17 Mar 2021. 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?
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?
System Usability (time frame: After patients have used the system. Approximately 4 to 8 weeks after baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2021.