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Virtual SMAs in Lifestyle Approach for Type 2 Diabetes

Primary Purpose

Diabetes Type 2

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Virtual SMAs
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Unidade de Saúde Familiar Homem do LemeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

Control arm

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 14, 2022
Last Updated
October 18, 2023
Sponsor
Universidade do Porto
Collaborators
Faculty of Medicine (FMUP), Unidade de Saúde Familiar Homem do Leme, Health4All Primary Healthcare Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT05279326
Brief Title
Virtual SMAs in Lifestyle Approach for Type 2 Diabetes
Official Title
Virtual Shared Medical Appointments (SMAs) in Lifestyle Approach for Type 2 Diabetes: Protocol of a Randomized Pragmatic Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Porto
Collaborators
Faculty of Medicine (FMUP), Unidade de Saúde Familiar Homem do Leme, Health4All Primary Healthcare Research Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm 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.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Participants will be at usual care and follow their usual contact with health services.
Intervention Type
Behavioral
Intervention Name(s)
Virtual SMAs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in glycaemic management, to be assessed by blood analysis
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in weight, to be assessed by weight balance
Description
Difference between the intervention and control group in the change of weight from baseline to the end of follow-up.
Time Frame
12 months
Title
Change in waist circumference, to be assessed by measuring tape
Description
Difference between the intervention and control group in the change of waist circumference from baseline to the end of follow-up.
Time Frame
12 months
Title
Change in systolic and diastolic blood pressure, to be assessed by sphygmomanometer
Description
Difference between the intervention and control group in the change in systolic and diastolic blood pressure from baseline to the end of follow-up.
Time Frame
12 months
Title
Change in fasting plasma triglycerides concentrations, to be assessed by blood analysis
Description
Difference between the intervention and control group in the change of serum triglycerides concentrations from baseline to the end of follow-up.
Time Frame
12 months
Title
Change in fasting plasma low density lipoprotein (LDL) concentrations, to be assessed by blood analysis
Description
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.
Time Frame
12 months
Title
Change in fasting plasma high density lipoprotein (HDL) concentrations, to be assessed by blood analysis
Description
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.
Time Frame
12 months
Title
Change in number of individual consultations, to be assessed by electronic health record
Description
Difference between the intervention and control group in the change of number of individual consultations from baseline to the end of follow-up.
Time Frame
12 months
Title
Change in use of medication, to be assessed by electronic health record
Description
Difference between the intervention and control group in the change of the use of medication from baseline to the end of follow-up.
Time Frame
12 months
Title
Change in the participants' satisfaction, to be assessed by questionnaire
Description
Difference between the intervention and control group in the participants' satisfaction from baseline to the end of follow-up.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosalia Pascoa, MD, PhDc
Phone
0351220426600
Email
rosaliapascoa@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosalia Pascoa, MD, PhDc
Organizational Affiliation
Faculty of Medicine (FMUP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unidade de Saúde Familiar Homem do Leme
City
Porto
ZIP/Postal Code
4150-502
Country
Portugal
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual SMAs in Lifestyle Approach for Type 2 Diabetes

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