None listed
Conditions
Brief summary
12 groups of 8-12 subjects will be chosen from 6 volunteer Western Sydney Medical Centres to attend 6 x fortnightly experiential learning sessions conducted as Programmed Shared Medical Appointments (pSMAs) in diabetes risk factor management. Participants will be selected from pre-diabetes and early diagnosed (3 years) Type 2 diabetes patients who are not on diabetic medications. The intervention will include a structured audio-visual presentation (12-15 minutes) before a discussion session with a trained facilitator (usually trained nurse or allied health professional), followed individual clinical consultations with a GP with all participants contributing. End-point outcomes (HbA1C, body weight) will be compared with standard treatment controls after 12 months. Patient and provider satisfaction with the process are secondary outcomes.
Interventions
Participants (120 or 12 groups x 10 per group) and controls (120) from 6 Primary Care Centres in Western Sydney will attend 6 x Shared Medical Appointments with a trained Facilitator and General Practitioner over 3 months in an experiential learning model aiming to prevent the progression of, or reverse early-stage Type 2 diabetes. Participants (8-12 per group) will be provided materials on physical activity, nutrition, stress management and sleep. A pre-prepared audio-visual presentation (12-1
Participants (120 or 12 groups x 10 per group) and controls (120) from 6 Primary Care Centres in Western Sydney will attend 6 x Shared Medical Appointments with a trained Facilitator and General Practitioner over 3 months in an experiential learning model aiming to prevent the progression of, or reverse early-stage Type 2 diabetes. Participants (8-12 per group) will be provided materials on physical activity, nutrition, stress management and sleep. A pre-prepared audio-visual presentation (12-15 minutes) will precede an interactive question and answer learning session with a trained Facilitator (Practice Nurse appropriate or Allied Health Professional (AHP)) followed by individual consultations by the GP with all present contributing. Materials supplied (Participant Handbook; Eating Plan; Patient Handouts) to participants and Facilitators have been prepared in conjunction with the Australian Society of Lifestyle Medicine (ASLM). Sessions last for approximately 100 minutes with the medical consultations taking 1 hour. Sessions will be conducted fortnightly over three months. Session topics (6) include 1 introduction (explaining Pre-diabetes), 2 on physical activity; weeks 2 and 4 - aerobic exercise and strength exercise; 2 on nutrition (physical and psychological components of nutrition and 1 on Stress and Sleep. Materials have been designed especially for this study but based on our previous study of weight control and the PREVIEW study on diabetes reversal. Adherence to strategies will be checked by questionnaire at the (immediate) end of the study.
Sponsors
NICM, Health Research Institute, University of Western Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Age 18-65 HbA1c <6.5>5.6 and no diagnosed diabetes or HbA1C <7.0 with T2D diagnosed within 3 years, but not on diabetic medication. Body weight/BMI (<45>24 for Caucasian and >22 for Asian and Aboriginal)
Exclusion criteria
Using insulin or metformin Weight loss of >5% in previous 6 months Current use of anti-obesity drugs known cancer Known learning difficulties pregnancy Presence of an eating or purging disorder
Outcome results
None listed