- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04039282
Exploring the Use of myfood24 (an Online Nutritional Assessment Tool) in Clinical Dietetic Practice
March 16, 2021 updated by: Sheffield Teaching Hospitals NHS Foundation Trust
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Sheffield, United Kingdom
- Sheffield Teaching Hospitals
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patient Participant
Patients will be asked to complete an 3 days worth of an online dietary recall prior to their out patient appointment with the dietitian
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online website for dietary analysis
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Other: Dietitian Participant
The Dietitian will be asked to review the patients completed dietary recalls prior to the patient attending their out patient appointment.
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online website for dietary analysis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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After patients have used the system. Approximately 4 to 8 weeks after baseline.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Activation
Time Frame: Baseline and end of intervention. (approximately 3 months from baseline)
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Patient activation score will be generated using Patient Activation Measure (PAM) a validated questionnaire.
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Baseline and end of intervention. (approximately 3 months from baseline)
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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)
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This will be generated using (I) Acceptability questionnaire for patients using a non-validated questionnaire and (2) Through participant interviews.
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The acceptability questionnaire and interviews will be completed at the end of the intervention.(approx 3 months from baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 22, 2019
Primary Completion (Actual)
March 31, 2020
Study Completion (Actual)
March 31, 2020
Study Registration Dates
First Submitted
July 26, 2019
First Submitted That Met QC Criteria
July 29, 2019
First Posted (Actual)
July 31, 2019
Study Record Updates
Last Update Posted (Actual)
March 17, 2021
Last Update Submitted That Met QC Criteria
March 16, 2021
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STH19780
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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