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| Name | Class |
|---|---|
| Unidade de Saúde Familiar Homem do Leme | UNKNOWN |
| Health4All Primary Healthcare Research Network | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | 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. |
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| Control arm | No Intervention | Participants will be at usual care and follow their usual contact with health services. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual SMAs | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosalia Pascoa, MD, PhDc | Contact | 0351220426600 | rosaliapascoa@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rosalia Pascoa, MD, PhDc | Universidade do Porto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade de Saúde Familiar Homem do Leme | Recruiting | Porto | 4150-502 | Portugal |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 |
| D004700 | Endocrine System Diseases |