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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04039282
Other study ID # STH19780
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 22, 2019
Est. completion date March 31, 2020

Study information

Verified date September 2019
Source Sheffield Teaching Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date March 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Device:
myfood24
online website for dietary analysis

Locations

Country Name City State
United Kingdom Sheffield Teaching Hospitals Sheffield

Sponsors (4)

Lead Sponsor Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust British Dietetic Association, Dietary Assessment Ltd, University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary System Usability System usability score is generated using system usability scale - a validated questionnaire. After patients have used the system. Approximately 4 to 8 weeks after baseline.
Secondary Patient Activation Patient activation score will be generated using Patient Activation Measure (PAM) a validated questionnaire. Baseline and end of intervention. (approximately 3 months from baseline)
Secondary 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. The acceptability questionnaire and interviews will be completed at the end of the intervention.(approx 3 months from baseline)
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