None listed
Conditions
Brief summary
The overall purpose of this trial is to evaluate the acceptability, feasibility and usability of the Miranda Impact Study App among people with obesity post bariatric surgery and on a supervised medication in selected tertiary care weight management clinics in NSW and VIC. The hypothesis is that the Miranda Impact Study App is applicable and feasible to use in a tertiary care weight management clinic and that its use will increase engagement, self-efficacy, consumer satisfaction and quality of life.
Interventions
This is a clinical trial of the Miranda Impact Study App. For the evaluation of the app, we will use a multisite randomised controlled study design within an overarching mixed method approach. The study will be conducted at two tertiary care weight management clinics (1 in NSW, 1 in VIC). The selected clinics are the Metabolism & Obesity Service, from the Royal Prince Alfred Hospital (NSW), and Weight Control Clinic from the Austin Health (VIC). The Miranda Impact Study App aims to support people who have undergone or are about to undergo bariatric surgery, medical weight loss and medically supervised lifestyle interventions. The development of the app has been conducted iteratively over multiple rounds, where each release of the app is tested internally and then released to a Reference Group for testing and feedback. The reference group consists of both Lived Experience (people lived or living with obesity) and obesity focused Clinical team members (Dieticians, Pharmacists, Surgeons). A simplified free version of the Miranda Impact Study App will be released in the iOS and Android app stores before this study. The simplified version will contain tracking functionality only. Through the app, study participants will be required to record their details (e.g. height, weight, waist measurement), surgical or medication journey, treatment-related symptoms, appetite and mood on a daily basis. Based on the information recorded daily, participants will receive instant personalised feedback from the app. Through the insights function, it assists people on post bariatric surgery or on a medication weight loss journey to monitor and address symptoms, potentially seeking healthcare professional support if conditions worsen. The app identifies the problems and what the issues are, which then helps guide what may be discussed in follow-up sessions or to address urgent issues more promptly. The app encourages adherence to lifestyle behaviours through user engagement and support. It also contains information on how to deal with side-effects and symptom management, provide answers to frequently asked questions and reminders to track and discuss topics with their healthcare team. The following are strategies that will be used to engage and re-engage participants with the app whilst the participants have the app installed and have provided consent for the relevant strategies. 1. In App Notifications and Reminders Only if the user has opted into notifications, they include a. Daily tracking reminders b. Medication reminders (if applicable) c. What’s new (features in the app) d. Motivational messages e. Inactive re-engagement prompts 2. Encouragement to enable notifications If the user has disabled notifications, we will periodically place a banner on the home page asking if they want to enable notifications. This banner can be dismissed. 3. Monthly reporting summary Only if the user has opted into reporting, they can receive a link to view their monthly summary of tracked data. 4. SMS re-engagement If the user has not re-engaged with the app in over a month, we will send a SMS that the user can opt out of any more similar messages in the future.
Sponsors
Study design
Eligibility
Inclusion criteria
- Adults aged 18 and over - Scheduled for bariatric surgery or have been prescribed and are commencing medication within the applicable study window. - Current patient at one of the participating clinical sites. - Own a smartphone (iOS or Android). - Able to read and understand English. - Able to provide informed consent.
Exclusion criteria
People who are not able to use the App in the way it is intended due to their mental health or neurodiversity (ability to participate would be determined by the person themselves in partnership with their treating clinician or trial nurse/coordinator). People who are starting medication and have had bariatric surgery within the past 12 months (the app does not provide the appropriate combined insights for this cohort).