Virtual SMAs in Lifestyle Approach for Type 2 Diabetes

NCT ID: NCT05279326

Last Updated: 2023-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Diabetes Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Virtual SMAs

Intervention Type BEHAVIORAL

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.

Control arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unidade de Saúde Familiar Homem do Leme

UNKNOWN

Sponsor Role collaborator

Health4All Primary Healthcare Research Network

UNKNOWN

Sponsor Role collaborator

Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rosalia Pascoa, MD, PhDc

Role: PRINCIPAL_INVESTIGATOR

Universidade do Porto

Locations

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Unidade de Saúde Familiar Homem do Leme

Porto, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Rosalia Pascoa, MD, PhDc

Role: CONTACT

0351220426600

Other Identifiers

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SMAs

Identifier Type: -

Identifier Source: org_study_id

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