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Effects of combining glucagon-like peptide-1 receptor agonist (GLP-1 RA) treatment with comprehensive personalised behavioural therapy on overweight and obese patients.

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.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000022561
Enrollment
1000
Registered
2024-01-11
Start date
2024-02-05
Completion date
2024-03-04
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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 asynchron

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.

Sponsors

Eucalyptus
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026