Virtual SMAs in Lifestyle Approach for Type 2 Diabetes

Universidade do Porto

Status: Enrolling

Conditions: Diabetes Type 2

Treatments: Behavioral: Virtual SMAs

Study type: Interventional

Funder types: Other

Identifiers

NCT05279326

SMAs

Details and patient eligibility

About

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups

Intervention arm

Experimental group

Description:

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.

Treatment:

Behavioral: Virtual SMAs

Control arm

No Intervention group

Description:

Participants will be at usual care and follow their usual contact with health services.