ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

'Nil known'

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity.

Condition category

Condition code

Diet and Nutrition

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]

Treatment: Drugs

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Body weight

Timepoint [1]

Baseline, 6 months post-commencement of treatment and 6 months following end of treatment

Primary outcome [2]

Ratio of fat-free mass to fat mass

Timepoint [2]

Baseline, 6 months post-commencement of treatment and 6 months following end of treatment

Primary outcome [3]

Composite strength (isometric squat, push and mid-thigh pull)

Timepoint [3]

Baseline, 6 months post-commencement of treatment and 6 months following end of treatment

Secondary outcome [1]

Side effects, e.g., gastrointestinal issues (diarrhea, constipation), stomach issues (nausea vomiting), dizziness, anxiety, fever and/or skin rash.

Timepoint [1]

Assessed weekly from baseline until 6 months following the end of treatment (12 months post-enrolment).

Secondary outcome [2]

BMI

Timepoint [2]

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?

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]

Commercial sector/Industry

Name [1]

Eucalyptus

Address [1]

Level 3/155 Clarence Street, Sydney 2000, NSW

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Eucalyptus

Address

Level 3/155 Clarence Street, Sydney 2000, NSW

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Bellberry Limited

Ethics committee address [1]

123 Glen Osmond Road, Eastwood, Adelaide, South Australia 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/12/2023

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

GLP-1 RA therapies have shown promise in tackling the alarming obesity rates in Australia and the rest of the world. However, concerns have been raised about the therapy's durability once patients come off the medication and the its effect on vital fat-free mass. The aim of this research is to assess the degree to which holistic weight-loss services delivered through virtual asynchronous means can generate lasting body composition benefits.  Patients will be randomly allocated into treatment and control groups to compare the effect of GLP-1 RA therapy in isolation versus GLP-1 therapy plus a comprehensive, personalised behavioural intervention. We believe that weight-loss, strength and fat-free mass outcomes will be significantly better in the treatment group at 6 months, and that these outcomes will be largely maintained 6 months after the end of treatment (12 months).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Louis Talay

Address

Eucalyptus VC, Level 3/155 Clarence Street, Sydney, NSW 2000

Country

Australia

Phone

+61 424696379

Fax

louis.talay@eucalyptus.vc

Contact person for public queries

Name

Louis Talay

Address

Eucalyptus VC, Level 3/155 Clarence Street, Sydney, NSW 2000

Country

Australia

Phone

+61 424696379

Fax

louis.talay@eucalyptus.vc

Contact person for scientific queries

Name

Louis Talay

Address

Eucalyptus VC, Level 3/155 Clarence Street, Sydney, NSW 2000

Country

Australia

Phone

+61 424696379

Fax

louis.talay@eucalyptus.vc

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: louis.talay@eucalyptus.vc

What supporting documents are/will be available?

Doc. No.	Type	Email
21128	Informed consent form	louis.talay@eucalyptus.vc
21129	Ethical approval	louis.talay@eucalyptus.vc
21130	Study protocol	louis.talay@eucalyptus.vc
21131	Statistical analysis plan	louis.talay@eucalyptus.vc

Results publications and other study-related documents

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No additional documents have been identified.

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