Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001449527p
Ethics application status
Not yet submitted
Date submitted
17/10/2024
Date registered
13/12/2024
Date last updated
13/12/2024
Date data sharing statement initially provided
13/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptability, feasibility and preliminary impact of a supportive care intervention, Miranda Impact Study App, for people undergoing bariatric surgery or on supervised medication for obesity treatment
Scientific title
A multi-site randomised controlled study to assess the acceptability and feasibility of implementation and preliminary impact of a supportive care intervention, Miranda Impact Study App, for people undergoing bariatric surgery or on supervised medication for obesity treatment.
Secondary ID [1] 313108 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 335391 0
Condition category
Condition code
Diet and Nutrition 331963 331963 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 329706 0
Prevention
Intervention code [2] 329707 0
Lifestyle
Intervention code [3] 329708 0
Treatment: Other
Comparator / control treatment
Usual care group
Control group
Active

Outcomes
Primary outcome [1] 339574 0
The feasibility of conducting the study as intended
Timepoint [1] 339574 0
At 3-month post use of the app
Primary outcome [2] 339575 0
The acceptability of the intervention
Timepoint [2] 339575 0
At 3-months post use of the app
Primary outcome [3] 339577 0
Usability
Timepoint [3] 339577 0
At 3-month post use of the app
Secondary outcome [1] 440480 0
Health literacy
Timepoint [1] 440480 0
At baseline and 3 months following use of the app
Secondary outcome [2] 440481 0
Health-related quality of life
Timepoint [2] 440481 0
At baseline and 3 months post app use
Secondary outcome [3] 440482 0
Self-efficacy
Timepoint [3] 440482 0
At baseline and at 3-month post app use
Secondary outcome [4] 440484 0
Engagement with healthcare professionals
Timepoint [4] 440484 0
At 3-month following app use
Secondary outcome [5] 440485 0
Health service use
Timepoint [5] 440485 0
At 3-month following app use.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomization of the group will occur after patients completed the baseline survey, either to use the app or to continue to receive their usual care. The person conducting the randomisation will not be involved in the recruitment of participants.
The method used will be central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised at a ratio of 3:1 to the intervention or control group stratified by treatment types (bypass surgery/ gastric surgery/medication) and age (<50 years, and =50 years). A random sequence will be generated for each of the eight strata using block randomisation (block size 4). For every four participants enrolled in each stratum, three will be allocated to the intervention group and one to the control group. The sequences will be generated electronically.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
30/09/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 317552 0
Charities/Societies/Foundations
Name [1] 317552 0
Impact Obesity
Country [1] 317552 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Impact Obesity
Address
Country
Australia
Secondary sponsor category [1] 319858 0
None
Name [1] 319858 0
Address [1] 319858 0
Country [1] 319858 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316263 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 316263 0
Ethics committee country [1] 316263 0
Australia
Date submitted for ethics approval [1] 316263 0
20/12/2024
Approval date [1] 316263 0
Ethics approval number [1] 316263 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137326 0
Dr Lahiru Russell
Address 137326 0
221 Burwood Highway, Burwood 3125 (Deakin University)
Country 137326 0
Australia
Phone 137326 0
+61423694939
Fax 137326 0
Email 137326 0
[email protected]
Contact person for public queries
Name 137327 0
Andrea Jasper
Address 137327 0
Cremorne House, 601/6 Adolph St, Cremorne, Vic 3121 (Impact Obesity)
Country 137327 0
Australia
Phone 137327 0
+61 432897747
Fax 137327 0
Email 137327 0
[email protected]
Contact person for scientific queries
Name 137328 0
Dr Alemayehu Mekonnen
Address 137328 0
221 Burwood Highway, Burwood 3125 (Deakin University)
Country 137328 0
Australia
Phone 137328 0
+61 3 924 43003
Fax 137328 0
Email 137328 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• All data requests will be considered by the principal investigator on a case-by-case basis and must be approved by the Sponsor.



Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified baseline and 3-month self-report quantitative data as specified in the primary and secondary outcomes.

What types of analyses could be done with individual participant data?
• For future research projects and during the peer review process, if needed.

When can requests for individual participant data be made (start and end dates)?
From:
Six months following main results publication, with no restriction on the data availability end date.





To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• By contacting the Principal Investigator Dr Lahiru Russel ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.