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

NCT07194317 | Completed

• 1 other identifier: 347758
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Obese Patients

Keywords

Digital health; Diet Assessment; Acceptability testing

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Following each test period of 1 week]

Secondary Outcomes (1)

• Patient experience and acceptability

  Within 4 months of completion of the tool testing

Study Arms (1)

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.

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

Interventions

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.

Feasibility and acceptability

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Trust

London, Southwark, SE1 9NH, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 39175746 RESULT

• 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.

  PMID: 28216582 RESULT

• 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.

  PMID: 40507092 RESULT

• 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.

  PMID: 38890501 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 26, 2025
• Study Start: September 1, 2025
• Primary Completion: March 13, 2026
• Study Completion: April 1, 2026
• Last Updated: May 29, 2026

Record last verified: 2025-09

Locations

GB (1)