None listed
Conditions
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 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
Study design
Eligibility
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.