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OpenTrials
Completed

NCT Number: NCT04758559

Usability of myfood24 in Clinical Populations

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.

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Key information

Conditions

Gastroenterology Surgery Body Weight Body Weight Changes Colorectal Surgery Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Change, Body Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Gastroenterology surgery, Leeds, W. Yorks, United Kingdom

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

myfood24

Other

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

Other names: myfood24 + diet optimisation

Usual Care

Other

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

Primary outcomes

  1. Usability of myfood24

    Time frame: 6 weeks

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

Secondary outcomes

  1. Ability of myfood24+ diet optimisation to change diet to meet diet targets

    Time frame: 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).

  2. Response rate

    Time frame: 6 weeks

    response rates prior to undertaking a full scale randomised controlled trial

  3. Correlation between diet and routine measure of body mass index

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Collaborators

  • Dietary Assessment Ltd

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2021
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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