Usability of myfood24 in Clinical Populations

Sponsor

University of Leeds (Other)

Overall Status

Recruiting

CT.gov ID

NCT04758559

Collaborator

Dietary Assessment Ltd (Other)

Enrollment

Locations

Arms

5.9

Anticipated Duration (Months)

Patients Per Site

5.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroenterology Surgery Colorectal Surgery Weight Loss Weight Change, Body	Other: myfood24 Other: usual care	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Usability of myfood24 in Clinical Populations

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

May 31, 2021

Anticipated Study Completion Date :

Jul 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Usual care Patients receive usual care concerning dietary advice.	Other: usual care Patients will receive standard advice as provided by the clinical team, this may or may not include nutrition.
Experimental: myfood24 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.	Other: myfood24 An app to support monitoring of food and nutrient intake using robust validated methodology. Other Names: myfood24 + diet optimisation
Experimental: myfood24 + diet optimisation 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.	Other: myfood24 An app to support monitoring of food and nutrient intake using robust validated methodology. Other Names: myfood24 + diet optimisation

Arm

Intervention/Treatment

Placebo Comparator: Usual care

Patients receive usual care concerning dietary advice.

Other: usual care

Patients will receive standard advice as provided by the clinical team, this may or may not include nutrition.

Experimental: myfood24

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.

Other: myfood24

An app to support monitoring of food and nutrient intake using robust validated methodology.

Other Names:

myfood24 + diet optimisation

Experimental: myfood24 + diet optimisation

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.

Other: myfood24

An app to support monitoring of food and nutrient intake using robust validated methodology.

Other Names:

myfood24 + diet optimisation

Outcome Measures

Primary Outcome Measures

Usability of myfood24 [6 weeks]
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 [6 weeks]
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 [6 weeks]
response rates prior to undertaking a full scale randomised controlled trial
Correlation between diet and routine measure of body mass index [6 weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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