Virtual SMAs in Lifestyle Approach for Type 2 Diabetes

Diabetes Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05279326
• Other study ID #: SMAs
• Status: Recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Universidade do Porto
• Contact: Rosalia Pascoa, MD, PhDc
• Phone: 0351220426600
• Email: rosaliapascoa[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Behavioral:
• Virtual 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.

Locations

Country	Name	City	State
Portugal	Unidade de Saúde Familiar Homem do Leme	Porto

Sponsors (4)

Lead Sponsor	Collaborator
Universidade do Porto	Faculty of Medicine (FMUP), Health4All Primary Healthcare Research Network, Unidade de Saúde Familiar Homem do Leme

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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