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

N/ACompletedNCT07194317

King's College London64 enrolled

Overview

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.

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

Allocation

Purpose

OTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Following each test period of 1 week]

Secondary Outcomes

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.

Time frame: Within 4 months of completion of the tool testing