Diabetes Type 2
Conditions
Brief summary
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.
Interventions
BEHAVIORALVirtual SMAs
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.
Sponsors
Unidade de Saúde Familiar Homem do Leme
Health4All Primary Healthcare Research Network
Universidade do Porto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycaemic management, to be assessed by blood analysis | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight, to be assessed by weight balance | 12 months | Difference between the intervention and control group in the change of weight from baseline to the end of follow-up. |
| Change in waist circumference, to be assessed by measuring tape | 12 months | Difference between the intervention and control group in the change of waist circumference from baseline to the end of follow-up. |
| Change in systolic and diastolic blood pressure, to be assessed by sphygmomanometer | 12 months | Difference between the intervention and control group in the change in systolic and diastolic blood pressure from baseline to the end of follow-up. |
| Change in fasting plasma triglycerides concentrations, to be assessed by blood analysis | 12 months | Difference between the intervention and control group in the change of serum triglycerides concentrations from baseline to the end of follow-up. |
| Change in fasting plasma low density lipoprotein (LDL) concentrations, to be assessed by blood analysis | 12 months | 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. |
| Change in fasting plasma high density lipoprotein (HDL) concentrations, to be assessed by blood analysis | 12 months | 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. |
| Change in number of individual consultations, to be assessed by electronic health record | 12 months | Difference between the intervention and control group in the change of number of individual consultations from baseline to the end of follow-up. |
| Change in use of medication, to be assessed by electronic health record | 12 months | Difference between the intervention and control group in the change of the use of medication from baseline to the end of follow-up. |
| Change in the participants' satisfaction, to be assessed by questionnaire | 12 months | Difference between the intervention and control group in the participants' satisfaction from baseline to the end of follow-up. |
Countries
Portugal
Contacts
Primary ContactRosalia Pascoa, MD, PhDc
Outcome results
None listed