RecruitingACTRN12619001353189

Prevention of Diabetes Progression in Primary Care through Shared Medical Appointments

Preventing progression in Type 2 Diabetes through Shared Medical Appointments with pre-diabetes patients in Primary Care: A controlled trial in translation research.


Sponsor

NICM, Health Research Institute, University of Western Sydney

Enrollment

240 participants

Start Date

Sep 23, 2019

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Prediabetes and early Type 2 diabetes are extremely common and carry serious long-term health risks if not addressed. However, managing these conditions often feels overwhelming, and many people struggle to make lasting changes on their own. This study is testing whether attending group medical appointments — called Programmed Shared Medical Appointments (pSMAs) — can help people with prediabetes or early diabetes better manage their blood sugar and body weight. Participants will attend six group sessions held every two weeks, run at GP practices in Western Sydney. Each session combines a structured presentation on diabetes risk factors with a group discussion facilitated by a trained nurse or allied health professional, followed by individual consultations with a GP. The key outcomes being measured are blood sugar (HbA1c) and body weight at 12 months. You may be eligible if you are aged 18 to 65, have prediabetes or Type 2 diabetes diagnosed within the last 3 years, are not currently on diabetes medication, and have a BMI above the healthy range. People currently on insulin or metformin, those who have lost significant weight recently, those with known cancer, or those who are pregnant are not eligible. This is a community-based, supportive program designed for people who want to take meaningful steps to reverse or slow the progression of diabetes.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Pract

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.


Locations(1)

NSW, Australia

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ACTRN12619001353189


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