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

What this study is testing ClinicalTrials.gov NCT07194317 ↗

Description as written by the study sponsor.

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.

Treatments tested

• 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.