NCT04758559

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. 1.usual care
  2. 2.myfood24Health
  3. 3.myfood24Health plus personalised feedback 'diet optimisation engine' which suggests changes to amounts or types of foods

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

1.4 years

First QC Date

February 9, 2021

Last Update Submit

December 3, 2024

Conditions

Gastroenterology SurgeryColorectal SurgeryWeight LossWeight Change, Body

Keywords

diet monitoringdiet optimisationnutrition

Outcome Measures

Primary Outcomes (1)

  • Usability of myfood24

    System usability scale 1 to 10. HIgher score is better. Online survey.

    6 weeks

Secondary Outcomes (3)

  • Ability of myfood24+ diet optimisation to change diet to meet diet targets

    6 weeks

  • Response rate

    6 weeks

  • Correlation between diet and routine measure of body mass index

    6 weeks

Study Arms (3)

Usual care

PLACEBO COMPARATOR

Patients receive usual care concerning dietary advice.

Other: usual care

myfood24

EXPERIMENTAL

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

myfood24 + diet optimisation

EXPERIMENTAL

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

Interventions

myfood24OTHER

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

Also known as: myfood24 + diet optimisation
myfood24myfood24 + diet optimisation
usual careOTHER

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

Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gastroenterology surgery

Leeds, W. Yorks, United Kingdom

Location

Tier 3 Weight Management Clinic

York, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 30089491RESULT

  • 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.

    PMID: 26024292RESULT

Related Links

MeSH Terms

Conditions

Weight LossBody Weight Changes

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised into: Usual care; myfood24; myfood24 with automated suggestions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 17, 2021

Study Start

January 1, 2020

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

December 6, 2024

Record last verified: 2024-12

Locations

GB(2)