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Usability of myfood24 in Clinical Populations

Primary Purpose

Gastroenterology Surgery, Colorectal Surgery, Weight Loss

Status
Unknown status
Phase
Early Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
myfood24
usual care
Sponsored by
University of Leeds
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroenterology Surgery focused on measuring diet monitoring, diet optimisation, nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

-

Sites / Locations

  • Gastroenterology surgeryRecruiting
  • Tier 3 Weight Management ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Usual care

myfood24

myfood24 + diet optimisation

Arm Description

Patients receive usual care concerning dietary advice.

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.

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.

Outcomes

Primary Outcome Measures

Usability of myfood24
System usability scale 1 to 10. HIgher score is better. Online survey.

Secondary Outcome Measures

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).
Response rate
response rates prior to undertaking a full scale randomised controlled trial
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

Full Information

First Posted
February 9, 2021
Last Updated
April 27, 2021
Sponsor
University of Leeds
Collaborators
Dietary Assessment Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04758559
Brief Title
Usability of myfood24 in Clinical Populations
Official Title
Usability of myfood24 in Clinical Populations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds
Collaborators
Dietary Assessment Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenterology Surgery, Colorectal Surgery, Weight Loss, Weight Change, Body
Keywords
diet monitoring, diet optimisation, nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Placebo Comparator
Arm Description
Patients receive usual care concerning dietary advice.
Arm Title
myfood24
Arm Type
Experimental
Arm Description
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.
Arm Title
myfood24 + diet optimisation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
myfood24
Other Intervention Name(s)
myfood24 + diet optimisation
Intervention Description
An app to support monitoring of food and nutrient intake using robust validated methodology.
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
Patients will receive standard advice as provided by the clinical team, this may or may not include nutrition.
Primary Outcome Measure Information:
Title
Usability of myfood24
Description
System usability scale 1 to 10. HIgher score is better. Online survey.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Ability of myfood24+ diet optimisation to change diet to meet diet targets
Description
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).
Time Frame
6 weeks
Title
Response rate
Description
response rates prior to undertaking a full scale randomised controlled trial
Time Frame
6 weeks
Title
Correlation between diet and routine measure of body mass index
Description
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
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janet Cade
Phone
+447875698368
Email
j.e.cade@leeds.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Uniacke
Facility Information:
Facility Name
Gastroenterology surgery
City
Leeds
State/Province
W. Yorks
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cath Moriarty
Facility Name
Tier 3 Weight Management Clinic
City
York
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Locker

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30089491
Citation
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.
Results Reference
result
PubMed Identifier
26024292
Citation
Carter 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.
Results Reference
result
Links:
URL
http://www.myfood24.org/
Description
website of myfood24 tool

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Usability of myfood24 in Clinical Populations

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