Clinical trial NCT04758559: Usability of myfood24 in Clinical Populations
Official title: Usability of myfood24 in Clinical Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Gastroenterology Surgery
Colorectal Surgery
Weight Loss
Weight Change, Body
Keywords: diet monitoring
diet optimisation
nutrition
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Dietary Assessment Ltd
First posted: 2021-02-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised into:

Usual care; myfood24; myfood24 with automated suggestions
Primary purpose: TREATMENT

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

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:

-

Primary outcomes:
measure: Usability of myfood24
timeFrame: 6 weeks
Secondary outcomes:
measure: Ability of myfood24+ diet optimisation to change diet to meet diet targets
timeFrame: 6 weeks
measure: Response rate
timeFrame: 6 weeks
measure: Correlation between diet and routine measure of body mass index
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Gastroenterology surgery
state: W. Yorks
city: York
country: United Kingdom
facility: Tier 3 Weight Management Clinic
Study officials:
References:
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.
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.