Virtual SMAs in Lifestyle Approach for Type 2 Diabetes

October 18, 2023 updated by: Universidade do Porto

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Portugal
      • Porto, Portugal, 4150-502
        • Recruiting
        • Unidade de Saúde Familiar Homem do Leme

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
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.
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.
No Intervention: Control arm
Participants will be at usual care and follow their usual contact with health services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycaemic management, to be assessed by blood analysis
Time Frame: 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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weight, to be assessed by weight balance
Time Frame: 12 months
Difference between the intervention and control group in the change of weight from baseline to the end of follow-up.
12 months
Change in waist circumference, to be assessed by measuring tape
Time Frame: 12 months
Difference between the intervention and control group in the change of waist circumference from baseline to the end of follow-up.
12 months
Change in systolic and diastolic blood pressure, to be assessed by sphygmomanometer
Time Frame: 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.
12 months
Change in fasting plasma triglycerides concentrations, to be assessed by blood analysis
Time Frame: 12 months
Difference between the intervention and control group in the change of serum triglycerides concentrations from baseline to the end of follow-up.
12 months
Change in fasting plasma low density lipoprotein (LDL) concentrations, to be assessed by blood analysis
Time Frame: 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.
12 months
Change in fasting plasma high density lipoprotein (HDL) concentrations, to be assessed by blood analysis
Time Frame: 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.
12 months
Change in number of individual consultations, to be assessed by electronic health record
Time Frame: 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.
12 months
Change in use of medication, to be assessed by electronic health record
Time Frame: 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.
12 months
Change in the participants' satisfaction, to be assessed by questionnaire
Time Frame: 12 months
Difference between the intervention and control group in the participants' satisfaction from baseline to the end of follow-up.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Collaborators

Unidade de Saúde Familiar Homem do Leme
Health4All Primary Healthcare Research Network
Faculty of Medicine (FMUP)

Investigators

  • Principal Investigator: Rosalia Pascoa, MD, PhDc, Faculty of Medicine (FMUP)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

March 3, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMAs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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