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

NCT ID: NCT07194317

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-04-01

Brief Summary

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guy's and St Thomas' NHS Trust

London, Southwark, United Kingdom

Countries

United Kingdom

References

Tanihara M, Suzuki Y, Yamamoto E, Noguchi A, Mizushima Y. Sustained release of basic fibroblast growth factor and angiogenesis in a novel covalently crosslinked gel of heparin and alginate. J Biomed Mater Res. 2001 Aug;56(2):216-21. doi: 10.1002/1097-4636(200108)56:23.0.co;2-n.

Reference Type: BACKGROUND

PMID: 11340591 (View on PubMed)

Polack FM. Modification of the immune graft response by azathioprine. Surv Ophthalmol. 1966 Aug;11(4):545-53. No abstract available.

Reference Type: BACKGROUND

PMID: 5331571 (View on PubMed)

Martin D. Postcodes and the 1991 census of population: issues, problems and prospects. Trans Inst Br Geogr. 1992;17(3):350-7.

Reference Type: BACKGROUND

PMID: 12157823 (View on PubMed)

van Eerde MR, Kampinga HH, Szabo BG, Vujaskovic Z. Comparison of three rat strains for development of radiation-induced lung injury after hemithoracic irradiation. Radiother Oncol. 2001 Mar;58(3):313-6. doi: 10.1016/s0167-8140(00)00301-7.

Reference Type: BACKGROUND

PMID: 11230893 (View on PubMed)

Other Identifiers

347758

Identifier Type: -

Identifier Source: org_study_id