NCT05279326

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
1.7 years until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 19, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

February 14, 2022

Last Update Submit

October 18, 2023

Conditions

Diabetes Type 2

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (9)

  • Change in weight, to be assessed by weight balance

    12 months

  • Change in waist circumference, to be assessed by measuring tape

    12 months

  • Change in systolic and diastolic blood pressure, to be assessed by sphygmomanometer

    12 months

  • Change in fasting plasma triglycerides concentrations, to be assessed by blood analysis

    12 months

  • Change in fasting plasma low density lipoprotein (LDL) concentrations, to be assessed by blood analysis

    12 months

  • +4 more secondary outcomes

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

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

Interventions

Virtual SMAsBEHAVIORAL

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 arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidade de Saúde Familiar Homem do Leme

Porto, 4150-502, Portugal

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Rosalia Pascoa, MD, PhDc

    Universidade do Porto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosalia Pascoa, MD, PhDc

CONTACT

0351220426600rosaliapascoa@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2022

First Posted

March 15, 2022

Study Start

December 1, 2023

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

October 19, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)