A Feasibility Study to Determine the Most Appropriate Digital Dietary Assessment Tool in Patients With Obesity Initiating GLP-1 Receptor Agonist Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Usability
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Testing 3 different digital dietary assessment tools in a random order (Nutritics-Libro, MyFood24 and Intake24) (Device)
结局指标
主要结局
Usability
时间窗: 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
时间窗: 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.
次要结局
- Patient experience and acceptability(Within 4 months of completion of the tool testing)