Study Results
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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UNKNOWN
NA
112 participants
INTERVENTIONAL
2023-12-31
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
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.
Control arm
Participants will be at usual care and follow their usual contact with health services.
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.
Eligibility Criteria
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Inclusion Criteria
* (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
* 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
18 Years
ALL
No
Sponsors
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Unidade de Saúde Familiar Homem do Leme
UNKNOWN
Health4All Primary Healthcare Research Network
UNKNOWN
Universidade do Porto
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Other Identifiers
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SMAs
Identifier Type: -
Identifier Source: org_study_id
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