Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000252617
Ethics application status
Approved
Date submitted
15/02/2023
Date registered
9/03/2023
Date last updated
1/06/2024
Date data sharing statement initially provided
9/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility and pilot study into the use of a phone app to enhance a virtual Meal Replacement weight loss Program.
Scientific title
"My VLED app study" a feasibility and pilot study into the use of a phone app to enhance a virtual Meal Replacement weight loss Program in adults with high BMIs.
Secondary ID [1] 309007 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 329049 0
Condition category
Condition code
Diet and Nutrition 326030 326030 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will use a type 2 hybrid effectiveness implementation trial design. The study will be conducted at the Metabolism & Obesity Service, Royal Prince Alfred Hospital Sydney Australia, a tertiary weight loss clinic. The clinic runs seven meal replacement group programs throughout the calendar year. The program is called “Rapid Weight Loss” and is conducted virtually using Zoom via six sessions over 12 weeks. Each group will be randomly assigned to either an enhanced, including a specifically developed mobile app, or a standard arm. Six groups will be included in the study three of each type. Data will be collected during and at the end of the 12-week program and then at 6, 9 and at the end of 12 months.
Patients who wish to attend the Rapid Weight Loss program, are allocated to the next available group after their referral to the clinic has been received. The Enhanced groups will be randomly assigned by pulling E (Enhanced Group) or S (Standard) cards out of a hat (3 of each group will be included). Session 1 of the 6 sessions explains the meal replacement program and in the Enhanced group it will also include an explanation of how to download and use the app My VLED. All information regarding the meal replacement program will be the same between the enhanced and control groups. The enhanced group will be encouraged to use the My VLED App to record weekly weight, biomarkers such blood glucose levels , and cholesterol markers (if known), blood pressure and monitor for symptoms. It will also provide information about the weight loss program.
Participants will be required to provide their own smart phone. There will be no penalty to the participant if they don't have a smart phone. Although patients will be encouraged to download and use the app they will not have to show proof of doing so as the clinician can see if they have downloaded the app or not. Part of the study is to see the uptake of the app.
All participants will be encouraged to ask questions during the online groups. The clinician will monitor the Enhanced group by checking the app dashboard and will be able to tailor information in the group sessions depending on the group’s progress. The Standard group will be asked to report their body weight each week to the clinician by email (current standard care). All participants are encouraged to get in contact if they have any questions or concerns.
At the end of the 12 weeks all participants will be asked to complete a short survey to determine acceptability of the app and the Rapid Weight Loss program and what factors were favourable or hindering. Program retention (number of weeks between first and last session attended,) and engagement with the study (number of group sessions attended), app usage behaviour and adherence to self-monitoring will also be assessed. Clinicians will be asked each week to provide an estimate of the amount of time spent interacting with participants outside the delivery of the online program. The number of emails received from participants will also be recorded. At the end of the study clinicians will provide feedback on the acceptability of the My VLED app from the clinicians’ point of view. Weight and attendance data will be compared between the two groups to ensure Enhanced program is at least equivalent to standard care. Weight and attendance data will be monitored at 3, 6 and 12 months post intervention.
Intervention code [1] 325449 0
Treatment: Devices
Comparator / control treatment
The control group will be the Rapid program without the addition of the My VLED App. All aspects of the study will be the same. The control group will not answer questions regarding the app but will be asked about the program.

The meal replacement program involves the following:
1) Attending 6 virtual sessions and following a meal replacement diet.
2)There are three variations on the diet prescribed,
Diet 1) is replacement of all three meals with meal replacement products plus, a teaspoon of oil, two bowls of low carbohydrate vegetables (= 10g carbohydrate per 100g), it provides approximately 72 g protein and 800kcal per day.
Diet 2) Diet one plus the addition of 100g of lean breast chicken, beef, fish or eggs and another cup of low carbohydrate vegetables per day 73-93 g of protein and 800-1000 kcal per day
Diet 3) involves Diet 1 plus 200g lean breast chicken, beef, fish or eggs plus 1 cups of low carbohydrate vegetables. >93g of protein and 1000-1200kcal per day.
The diet they are prescribed is based on their current weight and height and will provide them with approximately 1g of protein per kg of adjusted ideal body weight. (Ideal body weight is calculated at a BMI of 30).

Participants can choose from a range of brands that are suitable for a full meal replacement diet. They will be required to buy their own products.

They are recommended to follow this meal replacement plan for twelve weeks, followed by a period of gradual reduction of meal replacement products and introduction of a range of healthy foods. Patients are able to progress through this “phase out” of meal replacements over the timeframe that suits their goals.

The 6 virtual sessions, cover the following:
Session 1 how to follow the diet plan, and how it works. May also include information about the app if appropriate.
Sessions 2-6 are short presentations followed by an opportunity to ask questions and discuss challenges regarding any aspect of the diet. Topics covered in these sessions are:
• Why low carbohydrate vegetables are beneficial and tips on preparing them
• Different strategies to manage events, holidays and social occasions while on this meal replacement diet
• Overcoming barriers to exercise and tips to get started with exercise
• Step by step plan to move away from the full meal replacement plan, gradually reducing number of meal replacements with concurrent planned reintroduction of a variety of healthy foods
• How meal replacements can be used as part of a long-term weight management plan and common mistakes to avoid.

A dietitian administers the program and runs the sessions. Endocrinologist oversee the program.

Although adherence and monitoring are encouraged patients are not contacted to ensure this is occurring. The participant is responsible for attending the sessions fortnightly and reporting on their weight if not using the app. Attendance is marked at the beginning gof each session. Emails monitored for weights and the app dashboard can be used to see how the participants are going if used.
Control group
Active

Outcomes
Primary outcome [1] 333888 0
Acceptability. This will be measured via app usage data and results from the App questionnaire and the System Usability Scale. Both questionnaire utilises 5 point Likert scales. The app questionnaire uses Likert scales such as ones ranging from very good to terrible or very useable to very unusable. the System usability scale ranges from strongly agree to strongly disagree.
Timepoint [1] 333888 0
Acceptability via app usuage will be measured at 12 weeks 6 months and 12 months post commencement of intervention, Questionnaires will be measured at 12 weeks and 12 months post intervention
Primary outcome [2] 333889 0
Efficacy as measured by self reported weight change
Timepoint [2] 333889 0
12 weeks and 12 months post intervention
Primary outcome [3] 333890 0
Program retention this will include number of virtual sessions attended plus the length of time continued to be seen at clinic within the 12 month period.
Timepoint [3] 333890 0
12 weeks and 12 months post commencement of the intervention.
Secondary outcome [1] 418628 0
Factors that impact implementation as identified via the "App questionnaire"
Timepoint [1] 418628 0
12 months post commencement of intervention
Secondary outcome [2] 418629 0
Cost effectiveness - as determined by calculating difference between resource use (eg amount of time recorded weekly by clinician to: answer questions, record weight in medical records monitor for symptoms,
Timepoint [2] 418629 0
12 months post commencement of intervention

Eligibility
Key inclusion criteria
Patient are eligible to be enrolled in the Rapid weight loss program if they meet the following criteria:
1) have completed and returned their initial administration paper work that outlines their medical and anthropometry profile
2) have a BMI >30 with comorbidities or >35 with no comorbidities
3) Can read, speak and comprehend English
4) Do not have any medical issues that might preclude them from participating eg cushing syndrome, uncontrolled mental health issues, uncontrolled liver or renal disease, a diagnosed eating disorder
3) Wish to participate in the program

All patients who are enrolled in the “Rapid Weight Loss” online program at the Metabolism & Obesity Service, Royal Prince Alfred Hospital within a 12 month window from ethic approval will be eligible to take part
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no exclusion criteria as all participants who are eligible for the Rapid Weight loss program are also eligible to participate in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The groups will be randomized to either receive the app or not to receive the app. The randomization of the group will occur after patients have already been assigned to the group. The person conducting the randomisation will not know which participants are in each group nor will they be involved in the running of the groups. Randomization will occur the day before the commencement of the group to ensure patients are not placed in a group because of the enhancement.
Sealed opaque envelops will be used to randomise the groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization will occur by randomly drawing 1 or 6 sealed envelopes out of an opaque container. The envelopes will either have a E for enhanced (to use the app) or S for standard care inside. The envelopes and contents will be discarded once the card is drawn.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample t-tests and Chi-square tests will be used to analyse the results. Significance will be defined as p values < 0.05.
Analyses will be performed using Statistical Package for the Social Sciences (SPSS), Version 26.0, Armonk, NY, USA and STATA/IC version 14.2, Windows 64 bit (StataCorp LP, College Station, TX, USA).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/01/2024
Actual
19/01/2024
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
28/03/2026
Actual
Sample size
Target
250
Accrual to date
80
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24057 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 39559 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 313220 0
Government body
Name [1] 313220 0
Sydney Local Health District
Country [1] 313220 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital - Metabolism & Obesity Service
Address
Metabolism & Obesity Service
Level 6 west Bld 75
Royal Prince Alfred Hospital
Missenden Rd
Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 314941 0
None
Name [1] 314941 0
Address [1] 314941 0
Country [1] 314941 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312450 0
SLHD-RPA Zone
Ethics committee address [1] 312450 0
Ethics committee country [1] 312450 0
Australia
Date submitted for ethics approval [1] 312450 0
10/03/2023
Approval date [1] 312450 0
15/09/2023
Ethics approval number [1] 312450 0
X22-0443 & 2023/ETH01900

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

Contacts
Principal investigator
Name 124710 0
A/Prof Samantha Hocking
Address 124710 0
Metabolism & Obesity Service
Level 6 west Bld 75
RPAH
Missenden Rd
Camperdown, NSW 2050
Country 124710 0
Australia
Phone 124710 0
+61 2 95154220
Fax 124710 0
+61 2 95155820
Email 124710 0
samantha.hocking@health.nsw.gov.au
Contact person for public queries
Name 124711 0
Janet Franklin
Address 124711 0
Metabolism & Obesity Service
Level 6 west Bld 75
RPAH
Missenden Rd
Camperdown, NSW 2050
Country 124711 0
Australia
Phone 124711 0
+61 2 95154232
Fax 124711 0
+61 2 95155820
Email 124711 0
janet.franklin@health.nsw.gov.au
Contact person for scientific queries
Name 124712 0
Samantha Hocking
Address 124712 0
Metabolism & Obesity Service
Level 6 west Bld 75
RPAH
Missenden Rd
Camperdown, NSW 2050
Country 124712 0
Australia
Phone 124712 0
+61 2 95154220
Fax 124712 0
+61 2 95155820
Email 124712 0
samantha.hocking@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all de-identified individual participant data underlying published results only.
When will data be available (start and end dates)?
Immediately following publication, ending 5 years following main results publication;
Available to whom?
case-by-case basis at the discretion of principal investigator
Available for what types of analyses?
only to achieve the aims in the approved proposal,
How or where can data be obtained?
access subject to approvals by Principal Investigator contactable on samantha.hocking@health.nsw.gov.au


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.