Usability of myfood24 in Clinical Populations

Early Phase 1

Completed

• Conditions: Gastroenterology Surgery; Colorectal Surgery; Weight Loss; Weight Change, Body

• Registration Number: NCT04758559
• Lead Sponsor: University of Leeds

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

1. usual care

2. myfood24Health

3. 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.

Detailed Description

See published results at https://www.mdpi.com/2072-6643/14/9/1768

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-17
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Usability of myfood24	6 weeks	System usability scale 1 to 10. HIgher score is better. Online survey.

Secondary Outcome Measures

Name	Time	Method
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
Response rate	6 weeks	response rates prior to undertaking a full scale randomised controlled trial
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).

Trial Locations

Locations (2)

Gastroenterology surgery; 🇬🇧 Leeds, W. Yorks, United Kingdom

Tier 3 Weight Management Clinic; 🇬🇧 York, United Kingdom