Usability of myfood24 in Clinical Populations

Weight Loss Clinical Trial

Official title:

Usability of myfood24 in Clinical Populations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04758559
• Other study ID #: IRAS 266347
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 1, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: April 2021
• Source: University of Leeds
• Contact: Janet Cade
• Phone: +447875698368
• Email: j.e.cade[@]leeds.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Colorectal Surgery
• Gastroenterology Surgery
• Weight Change, Body
• Weight Loss

Intervention

Other:
• myfood24
An app to support monitoring of food and nutrient intake using robust validated methodology.
• usual care
Patients will receive standard advice as provided by the clinical team, this may or may not include nutrition.

Locations

Country	Name	City	State
United Kingdom	Gastroenterology surgery	Leeds	W. Yorks
United Kingdom	Tier 3 Weight Management Clinic	York

Sponsors (2)

Lead Sponsor	Collaborator
University of Leeds	Dietary Assessment Ltd

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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: — View 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 assessme — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability of myfood24	System usability scale 1 to 10. HIgher score is better. Online survey.	6 weeks
Secondary	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
Secondary	Response rate	response rates prior to undertaking a full scale randomised controlled trial	6 weeks
Secondary	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

External Links

•   website of myfood24 tool