Usability of myfood24 in Clinical Populations

Study Overview
=================
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.

Official Title
-----------------
Usability of myfood24 in Clinical Populations

Conditions
-----------------
Gastroenterology Surgery, Colorectal Surgery, Weight Loss, Weight Change, Body

Intervention / Treatment
-----------------
* Other: myfood24
* Other: usual care


Participation Criteria
=================
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: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of myfood24 | System usability scale 1 to 10. HIgher score is better. Online survey. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 6 weeks | 
| Response rate | response rates prior to undertaking a full scale randomised controlled trial | 6 weeks | 
| 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 | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diet monitoring, diet optimisation, nutrition