Obese PatientsFIDGETNCT07194317

A Feasibility Study to Determine the Most Appropriate Digital Dietary Assessment Tool in Patients With Obesity Initiating GLP-1 Receptor Agonist Treatment

A study testing Testing 3 different digital dietary assessment tools in a random order (Nutritics-Libro, MyFood24 and Intake24) in people with Obese Patients, run by King's College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Obese Patients
What is being tested?: Testing 3 different digital dietary assessment tools in a random order (Nutritics-Libro, MyFood24 and Intake24)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Sep 2025to 1 Apr 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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.

Who cannot join

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

Show all 14Show fewer

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Guy's and St Thomas' NHS Trust
London, Southwark, SE1 9NH

Other trials in United Kingdom

About this study

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.

Read the 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).

Conditions: Obese Patients
Being tested: Testing 3 different digital dietary assessment tools in a random order (Nutritics-Libro, MyFood24 and Intake24)
Keywords: Digital health, Diet Assessment, Acceptability testing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Testing 3 different digital dietary assessment tools in a random order (Nutritics-Libro, MyFood24 and Intake24)Device
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.

Study groups in NCT07194317
Study group	Role	What they receive
Feasibility and acceptability	Other	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. Receives: Device: Testing 3 different digital dietary assessment tools in a random order (Nutritics-Libro, MyFood24 and Intake24)

What is being measured

The primary outcome is the main question the study is designed to answer.

Usability
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.
Measured: Following each test period of 1 week
Usability and context of use
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.
Measured: Following each test period of 1 week]

Secondary outcomes (1)

Patient experience and acceptability
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.
Measured: Within 4 months of completion of the tool testing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20251 Apr 2026

First posted26 Sep 2025
Study start1 Sep 2025
Primary completion13 Mar 2026
Study completion1 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Obese PatientsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: Over three weeks participants will be asked to record three consecutive days of dietary intake each week using a different tool. Participants will be assigned to an order they complete the three tools from six different sequence options. The order will be assigned based on auto number generation.
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07194317
Sponsor's protocol ID: 347758
Acronym: FIDGET
Status last verified: Sep 2025
First submitted: 8 Sep 2025
Last updated: 29 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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.
PubMed 39175746
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.
PubMed 28216582
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.
PubMed 40507092
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.
PubMed 38890501

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obese Patients trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility Study to Determine the Most Appropriate Digital Dietary Assessment Tool in Patients With Obesity Initiating GLP-1 Receptor Agonist Treatment
ClinicalTrials.gov ID: NCT07194317
Acronym / sponsor ID: FIDGET / 347758
Conditions: Obese Patients
Keywords: Digital health, Diet Assessment, Acceptability testing
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: King's College LondonUniversity, hospital or other
Collaborators: Guy's and St Thomas' NHS Foundation Trust
Study start: 1 Sep 2025 (actual)
Primary completion: 13 Mar 2026 (actual)
Study completion: 1 Apr 2026 (actual)
First posted: 26 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Over three weeks participants will be asked to record three consecutive days of dietary intake each week using a different tool. Participants will be assigned to an order they complete the three tools from six different sequence options. The order will be assigned based on auto number generation.

Arm	Type	Receives
Feasibility and acceptability	Other	Device: Testing 3 different digital dietary assessment tools in a random order (Nutritics-Libro, MyFood24 and Intake24)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (14 listed)

Adults aged >18 years

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Testing 3 different digital dietary assessment tools in a random order (Nutritics-Libro, MyFood24 and Intake24)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.	Device	Feasibility and acceptability

Primary outcome

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.
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.

1 secondary outcome

Patient experience and acceptability
Time frame: Within 4 months of completion of the tool testing

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
Results publication: PubMed 39175746Christensen 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.
Results publication: PubMed 28216582Burrows 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.
Results publication: PubMed 40507092Basso 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.
Results publication: PubMed 38890501Astrup 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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Usability (time frame: Following each test period of 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07194317, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.