- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07194317
- Original Trial
A Feasibility Study to Determine the Most Appropriate Digital Dietary Assessment Tool in Patients With Obesity Initiating GLP-1 Receptor Agonist Treatment (FIDGET)
May 28, 2026 updated by: King's College London
New medications that work on gut hormones such as semaglutide (Wegovy) and tirzepatide (Mounjaro) are helping many people lose weight and are now recommended for treating obesity by the NHS.
While these treatments are effective for weight loss, we don't yet know how they affect what people eat or their overall nutrition.
Understanding diet before, during, and after treatment is important.
Traditional ways of tracking diet, like paper food diaries, can be difficult to use and are time consuming for clinicians to interpret and record in clinical notes.
Digital tools like MyFood24, Nutritics-Libro, and Intake24 may offer a better way to record what people eat, but we need to find out if they can be easily used in everyday healthcare settings.
The FIDGET study will test how well these digital diet tools can be used in clinics and linked with electronic health records.
The study will use surveys and group discussions to understand how patients and healthcare professionals feel about using these tools.
Study Overview
Status
Completed
Conditions
Detailed Description
Gut hormone-based therapies including the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy) and dual glucose-dependent insulinotropic polypeptide (GIP)/ GLP-1 receptor agonist Tirzepatide (Mounjaro) are increasingly effective in weight management, leading to their recommendations for obesity treatment in the UK's National Health Service (NHS).
These medications support weight loss; however, their impact on dietary intake and nutritional status remains unexplored.
Assessing diet is essential before, during and after treatment.
Several digital dietary assessment tools address limitations of traditional paper-based methods; however, feasibility of integrating these digital tools into routine clinical workflows has not been assessed.
The Feasibility of Digital Dietary Assessment (FIDGET) study will evaluate integration of digital dietary recording tools (MyFood24, Nutritics-Libro and Intake24) into routine clinical workflows and electronic health record, using a randomised crossover design with mixed-methods evaluation (quantitative cross-sectional surveys, qualitative focus groups).
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Southwark
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London, Southwark, United Kingdom, SE1 9NH
- Guy's and St Thomas' NHS Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults aged >18 years
- Living with obesity as diagnosed by healthcare professional.
- Referral to T3WMS at GSTT and currently on the service waiting list
- Eligible for GLP-1 receptor agonist (Wegovy) prescription
- Have an active MyChart account
- Have an email address
- Access to a digital device such as a smart phone, computer or tablet where you can access the internet
- Not following a meal replacement diet, for example soups / shakes
- Able to provide informed consent.
- Able to complete surveys in English.
Exclusion Criteria:
Adults aged >18 years
- Living with obesity as diagnosed by healthcare professional.
- Referral to T3WMS at GSTT and currently on the service waiting list
- Eligible for GLP-1 receptor agonist (Wegovy) prescription
- Have an active MyChart account
- Have an email address
- Access to a digital device such as a smart phone, computer or tablet where you can access the internet
- Not following a meal replacement diet, for example soups / shakes
- Able to provide informed consent.
- Able to complete surveys in English.
- Not able to provide informed consent
- Not able to complete surveys in English
- Has an eating disorder
- Taking part in another research trial that involves dietary modification
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Feasibility and acceptability
Participants will record their dietary intake over three weeks, using a different tool for three consecutive days each week.
The digital tools are: MyFood24, Nutritics-Libro and Intake24.The order sequence to complete will be from auto number generation.
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55 participants will be recruited (target to complete the study n=50).
The acceptability trial will be conducted remotely.
A baseline questionnaire will capture demographic data.
Over three weeks participants will be asked to record three random consecutive days of dietary intake each week using a different tool.
Participants will be randomised to the order they complete the tools.
To minimise potential biases.
Participants will be randomly assigned to one of the six possible tool completion sequences (Table 1) using a relevant participant randomization package (e.g., rempsyc) in R (v4.4.2), which is a free, open-source statistical software used for data analysis and randomisation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Usability
Time Frame: Following each test period of 1 week
|
Participants will complete a questionnaire to assess their experience and acceptability of using the tool.
The System Usability Scale (SUS) will be used to measure the usability of the digital dietary assessment tools.
A higher score denotes the system is more user friendly.
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Following each test period of 1 week
|
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Usability and context of use
Time Frame: Following each test period of 1 week]
|
Participants will complete a questionnaire to assess their experience and acceptability of using the tool.
The modified version of the Rawl Usability Questionnaire - this measures the usability of specific features of digital applications and context of use.
|
Following each test period of 1 week]
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient experience and acceptability
Time Frame: Within 4 months of completion of the tool testing
|
This is a qualitative outcome.
A purposive sub-sample of 10 participants from the testing phase will be invited participate in one of two online focus groups to discuss their experiences of the dietary assessment tools.
The focus group questions were designed to assess two main domains (patient experience and acceptability).The Quadruple Aim framework and the Theoretical Framework of Acceptability (TFA) guided the development of the questions to capture participants' overall experience including tool usability, perceived usefulness and accuracy, impact on daily routine and satisfaction.
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Within 4 months of completion of the tool testing
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Christensen S, Robinson K, Thomas S, Williams DR. Dietary intake by patients taking GLP-1 and dual GIP/GLP-1 receptor agonists: A narrative review and discussion of research needs. Obes Pillars. 2024 Jul 25;11:100121. doi: 10.1016/j.obpill.2024.100121. eCollection 2024 Sep.
- Burrows TL, Rollo ME, Williams R, Wood LG, Garg ML, Jensen M, Collins CE. A Systematic Review of Technology-Based Dietary Intake Assessment Validation Studies That Include Carotenoid Biomarkers. Nutrients. 2017 Feb 14;9(2):140. doi: 10.3390/nu9020140.
- Basso M, Zhang L, Savva GM, Cohen Kadosh K, Traka MH. Relative Validity of the Food Recording Smartphone App Libro in Young People Vulnerable to Eating Disorder: A Preliminary Cross-Over Study. Nutrients. 2025 May 27;17(11):1823. doi: 10.3390/nu17111823.
- Astrup A. Reflections on the discovery GLP-1 as a satiety hormone: Implications for obesity therapy and future directions. Eur J Clin Nutr. 2024 Jul;78(7):551-556. doi: 10.1038/s41430-024-01460-6. Epub 2024 Jun 18.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2025
Primary Completion (Actual)
March 13, 2026
Study Completion (Actual)
April 1, 2026
Study Registration Dates
First Submitted
September 8, 2025
First Submitted That Met QC Criteria
September 18, 2025
First Posted (Actual)
September 26, 2025
Study Record Updates
Last Update Posted (Actual)
May 29, 2026
Last Update Submitted That Met QC Criteria
May 28, 2026
Last Verified
September 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 347758
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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