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Shared Medical Appointments for Type 2 Diabetes

Shared Medical Appointments for Type 2 Diabetes - a randomised controlled feasibility study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000892112
Enrollment
18
Registered
2019-06-26
Start date
2019-05-23
Completion date
2019-06-04
Last updated
2026-08-03

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

Conditions

None listed

Brief summary

This is a randomised controlled feasibility study. The first aim of this study is to collaborate with community and local health organisations in order to co-design a preventive program for Type 2 diabetes (T2D). The second aim is to pilot the program using a small-scale clinical trial in order to determine how feasible and acceptable it is to end users. This new information will then be used to design a larger clinical trial which will provide definitive knowledge about the effectiveness of our program in preventing and managing T2D.

Interventions

The intervention is a programmed Shared Medical Appointment program (pSMAs) with mindfulness.The intervention involves six 2 hour pSMAs, delivered at Western Sydney Integrative Health by a GP, facilitator (allied health professional), documenter and a meditation teacher. The overall duration and frequency of the program is six fortnightly pSMAs. Educational content will include: • Overall management of diabetes and importance of lifestyle modifications; • Healthy eating for diabetes and weight

The intervention is a programmed Shared Medical Appointment program (pSMAs) with mindfulness.The intervention involves six 2 hour pSMAs, delivered at Western Sydney Integrative Health by a GP, facilitator (allied health professional), documenter and a meditation teacher. The overall duration and frequency of the program is six fortnightly pSMAs. Educational content will include: • Overall management of diabetes and importance of lifestyle modifications; • Healthy eating for diabetes and weight loss; • Physical activity; • Exploring and overcoming barriers to lifestyle changes; and • Supporting psychological wellbeing. Participants are encouraged to set their own lifestyle goals based on the RACGP handbook on General Practice Management of Type 2 Diabetes. Key goals will include weight loss of 5%, as improvements in weight have a significant impact on glycaemic control. The mindfulness component will be delivered by an experienced meditation teacher and will consist of 15-20 minutes of guided mindfulness meditation and informed by previous RCTs on mindfulness for weight loss. The pSMAs will be complemented by a workbook for reference and recording goals, and home mindfulness practice exercises. Typically, SMAs involve 10-12 participants per group. The schedule for pSMAs follows: Introduction and warm-up (facilitator only):5-10 minutes; Structured educational session (facilitator and allied health professional): 30 minutes; Mindfulness component: 15-20 minutes Individual GP consultations: 50-60 minutes. 10-12 individual GP consultations will be conducted over 50-60 minutes with about 5 minutes consultation per participant, in a group setting.Participants ask questions of the GP that they would ask of any GP during a medical consultation about their diabetes. This may include: interpretation of blood test results and physical examination findings; questions about medications; lifestyle advice; management of stress. For the home mindfulness practice, there is no prescribed time but participants are sent a weekly reminder and are encouraged to meditate as per their preference. A daily meditation is suggested but the duration is up to the participant.

Sponsors

Western Sydney University
Lead SponsorUniversity

Study design

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

Eligibility

Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Age > 21; • Living in Western Sydney; • Diagnosed with Type 2 diabetes (HbA1c > 6.5% OR fasting blood glucose > 7mmol/L) within the past 12 months; will need to be confirmed with a repeat test if there is no HbA1c result within the past 3 months; • Has a smartphone compatible for the use of the FreeStyle LibreLink App (NFC enabled phones running Android 5.0 or higher, or with iPhone 7 or higher, running iOS 11, or higher);

Exclusion criteria

• Unable to attend for SMAs; • Pregnant or planning pregnancy in next 3 months; • Serious medical or psychological conditions (e.g., metastatic cancer, poorly controlled schizophrenia); • Not fluent in English (unable to follow conversations and instructions in English and unable to read English); • Known allergy to medical adhesives.

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 9, 2026