Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000022561p
Ethics application status
Submitted, not yet approved
Date submitted
5/12/2023
Date registered
11/01/2024
Date last updated
11/01/2024
Date data sharing statement initially provided
11/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of combining glucagon-like peptide-1 receptor agonist (GLP-1 RA) treatment with comprehensive personalised behavioural therapy on overweight and obese patients.
Scientific title
A randomised, double-blind, active-controlled study to evaluate the efficacy, safety and sustainability of a comprehensive real-world digital asynchronous weight management service that combines glucagon-like peptide-1 receptor agonist (GLP-1 RA) treatment with proactive personalised guidance in nutrition, and resistance and aerobic training in adults with overweight or obesity.
Secondary ID [1] 311064 0
'Nil known'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity. 332199 0
Condition category
Condition code
Diet and Nutrition 328914 328914 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the treatment group will receive weekly subcutaneous injections of 2.5mg Tirzepatide for 4 weeks, with the dose increasing to 5mg from week 5 until the end of the intervention period at 6 months. Tirzepatide will be sent to patients on a monthly basis to self-administer, along with return labels to allow study investigators to monitor treatment adherence (drug vial return).

As part of the group's comprehensive behavioural intervention, participants will have access to asynchronous, patient-initiated health coaching 5 days a week, 18 hours a day for the duration of the intervention. Health coaching (diet and exercise) will be delivered by a team of dietitians and mental health nurses through a mobile phone application in the form of videos, text messages, infographics and spreadsheets, and will be personalised for each treatment group participant, based on the assessment of the prescribing doctor and the participant's goal setting sessions with their health coaching team. Each treatment group participant will receive a minimum of 1 asynchronous goal-setting and accountability session (45 minutes) and weekly asynchronous check-ins (15 minutes) for the first 12 weeks of treatment. Participant adherence to the behavioural intervention will be monitored through app analytics of weight-logging frequency, food diary input (text and image), and total app engagement.

From months 6 to 12, participants in the treatment group will continue to have access to educational resources and their goals via the program app but will no longer be able to communicate with their multidisciplinary team.

Intervention code [1] 327557 0
Treatment: Drugs
Intervention code [2] 327558 0
Lifestyle
Intervention code [3] 327559 0
Behaviour
Comparator / control treatment
Participants in the control group will receive the same medical intervention as participants in the treatment group, i.e., weekly subcutaneous injections of 2.5mg Tirzepatide for 4 weeks, with the dose increasing to 5mg from week 5 until the end of the intervention period at 6 months. For the behavioural intervention, control group participants will receive standardised diet and exercise counselling in a group session at the start of the trial (based on World Health Organisation recommendations). The group session will be delivered by a dietitian via videoconferencing software (Zoom) to a maximum of 20 participants per group. A summary sheet of the session's recommendations will be sent to control group participants at months 2 and 4 of the trial period. Session attendance checklists and email logs will be used to monitor adherence to group sessions.
Control group
Active

Outcomes
Primary outcome [1] 336771 0
Body weight
Timepoint [1] 336771 0
Baseline, 6 months post-commencement of treatment and 6 months following end of treatment
Primary outcome [2] 336773 0
Ratio of fat-free mass to fat mass
Timepoint [2] 336773 0
Baseline, 6 months post-commencement of treatment and 6 months following end of treatment
Primary outcome [3] 336774 0
Composite strength (isometric squat, push and mid-thigh pull)
Timepoint [3] 336774 0
Baseline, 6 months post-commencement of treatment and 6 months following end of treatment
Secondary outcome [1] 429640 0
Side effects, e.g., gastrointestinal issues (diarrhea, constipation), stomach issues (nausea vomiting), dizziness, anxiety, fever and/or skin rash.
Timepoint [1] 429640 0
Assessed weekly from baseline until 6 months following the end of treatment (12 months post-enrolment).
Secondary outcome [2] 430145 0
BMI
Timepoint [2] 430145 0
Baseline, 6 months post-commencement of treatment and 6 months following end of treatment

Eligibility
Key inclusion criteria
BMI of 30 or greater (obese); or BMI of 27 or greater (overweight) with at least 1 weight-related comorbidity (e.g. hypertension, dyslipidemia, CVD).

For participants of Aboriginal, Torres Strait Islander, Pacific Islander, Maori, Asian (Including Indian Subcontinent), Middle Eastern, Black African or African-Caribbean backgrounds, the cutoffs are as follows:

Obesity: BMI 27.5 or above
Overweight: BMI 23 - 27.4, plus at least one weight-related comorbidity
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Diabetes
-Pregnant
-History of chronic pancreatitis
-Acute pancreatitis within 180 days before enrollment
-Serious mental health conditions
-Previous surgical obesity treatment
-Use of antiobesity medication within 90 days before enrollment

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)
Allocation concealed: central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/02/2024
Actual
Date of last participant enrolment
Anticipated
4/03/2024
Actual
Date of last data collection
Anticipated
7/04/2025
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315321 0
Commercial sector/Industry
Name [1] 315321 0
Eucalyptus
Country [1] 315321 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Eucalyptus
Address
Level 3/155 Clarence Street, Sydney 2000, NSW
Country
Australia
Secondary sponsor category [1] 317427 0
None
Name [1] 317427 0
Address [1] 317427 0
Country [1] 317427 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314243 0
Bellberry Limited
Ethics committee address [1] 314243 0
Ethics committee country [1] 314243 0
Australia
Date submitted for ethics approval [1] 314243 0
05/12/2023
Approval date [1] 314243 0
Ethics approval number [1] 314243 0

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

Contacts
Principal investigator
Name 130914 0
Dr Louis Talay
Address 130914 0
Eucalyptus VC, Level 3/155 Clarence Street, Sydney, NSW 2000
Country 130914 0
Australia
Phone 130914 0
+61 424696379
Fax 130914 0
Email 130914 0
[email protected]
Contact person for public queries
Name 130915 0
Louis Talay
Address 130915 0
Eucalyptus VC, Level 3/155 Clarence Street, Sydney, NSW 2000
Country 130915 0
Australia
Phone 130915 0
+61 424696379
Fax 130915 0
Email 130915 0
[email protected]
Contact person for scientific queries
Name 130916 0
Louis Talay
Address 130916 0
Eucalyptus VC, Level 3/155 Clarence Street, Sydney, NSW 2000
Country 130916 0
Australia
Phone 130916 0
+61 424696379
Fax 130916 0
Email 130916 0
[email protected]

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 individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Available immediately after publication with no end date.
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Only to achieve the aims in the approved proposal, such as IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator who can be contacted via email: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21128Informed consent form  [email protected]
21129Ethical approval  [email protected]
21130Study protocol  [email protected]
21131Statistical analysis plan  [email protected]



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.