Virtual SMAs in Lifestyle Approach for Type 2 Diabetes

Study Overview
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Brief Summary
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This study protocol presents the design of a randomized pragmatic trial. This study aims to determine the effectiveness of virtual shared medical appointments (SMAs) lifestyle approach in improving glycaemic control, compared to usual care in type 2 diabetes (T2D) subjects.

Official Title
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Virtual Shared Medical Appointments (SMAs) in Lifestyle Approach for Type 2 Diabetes: Protocol of a Randomized Pragmatic Trial

Conditions
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Diabetes Type 2

Intervention / Treatment
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* Behavioral: Virtual SMAs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) be 18 years old or older (2) have a diagnosis of T2D with HbA1c ≥ 6.5% within the preceding 6 months (3) have body mass index (BMI) ≥ 25.0 kg/m2 within the preceding 6 months (4) have access to a camera and internet Exclusion Criteria: unable to attend virtual SMAs for diagnosis of dementia or other cognitive impairment and any behavioral problem, which interferes with group participation and discussion not fluent in Portuguese, and unable to follow conversations, read instructions, and read in Portuguese being pregnant or planning a pregnancy in the next year attending a weight loss and/or physical activity counseling program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Participants will receive virtual SMAs and usual care. Virtual SMAs will last 90 minutes, every 3 weeks, in 18 weeks through an online platform, at no cost to participants beyond the use of the device and the internet. | Behavioral: Virtual SMAs<br>* 18 weeks lifestyle approach for type 2 diabetes program: Session 1 (week 0): Introduction; Session 2 (week 3): Behaviour change process; Session 3 (week 6): Medical nutrition therapy recommendations - Part 1; Session 4 (week 9): Medical nutrition therapy recommendations - Part 2; Session 5 (week 12): Medical physical Activity recommendations; Session 6 (week 15): Smoking cessation: tobacco and E-cigarettes; Session 7 (week 18): Diabetes distress.<br>|
| No Intervention: Control arm<br>Participants will be at usual care and follow their usual contact with health services. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycaemic management, to be assessed by blood analysis | Difference between the intervention and control group in the change of serum glycated hemoglobin A1c (HbA1c) concentrations from baseline to the end of follow-up. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight, to be assessed by weight balance | Difference between the intervention and control group in the change of weight from baseline to the end of follow-up. | 12 months | 
| Change in waist circumference, to be assessed by measuring tape | Difference between the intervention and control group in the change of waist circumference from baseline to the end of follow-up. | 12 months | 
| Change in systolic and diastolic blood pressure, to be assessed by sphygmomanometer | Difference between the intervention and control group in the change in systolic and diastolic blood pressure from baseline to the end of follow-up. | 12 months | 
| Change in fasting plasma triglycerides concentrations, to be assessed by blood analysis | Difference between the intervention and control group in the change of serum triglycerides concentrations from baseline to the end of follow-up. | 12 months | 
| Change in fasting plasma low density lipoprotein (LDL) concentrations, to be assessed by blood analysis | Difference between the intervention and control group in the change of serum low density lipoprotein (LDL) concentrations from baseline to the end of follow-up. | 12 months | 
| Change in fasting plasma high density lipoprotein (HDL) concentrations, to be assessed by blood analysis | Difference between the intervention and control group in the change of serum high density lipoprotein (HDL) concentrations from baseline to the end of follow-up. | 12 months | 
| Change in number of individual consultations, to be assessed by electronic health record | Difference between the intervention and control group in the change of number of individual consultations from baseline to the end of follow-up. | 12 months | 
| Change in use of medication, to be assessed by electronic health record | Difference between the intervention and control group in the change of the use of medication from baseline to the end of follow-up. | 12 months | 
| Change in the participants' satisfaction, to be assessed by questionnaire | Difference between the intervention and control group in the participants' satisfaction from baseline to the end of follow-up. | 12 months |