Virtual SMAs in Lifestyle Approach for Type 2 Diabetes

Not Applicable

Recruiting

• Conditions: Diabetes Type 2
• Interventions: Behavioral: Virtual SMAs

• Registration Number: NCT05279326
• Lead Sponsor: Universidade do Porto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-14
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Study Start: 2023-12
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Virtual SMAs	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.
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 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 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 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 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.

Trial Locations

Locations (1)

Unidade de Saúde Familiar Homem do Leme; 🇵🇹 Porto, Portugal