Type 2 Diabetes Clinical Trial
— Td2AstOfficial title:
Effectiveness of a Primary Care Diet and Physical Activity Educational Program for Patients With Type 2 Diabetes Mellitus
NCT number | NCT05383859 |
Other study ID # | 2022.014 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2022 |
Est. completion date | March 31, 2023 |
Verified date | May 2023 |
Source | University of Oviedo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
An individualized educational intervention are going to be developed. Its based on the COM-B model, designed and applied by Primary Care nursing professionals for patients with type 2 diabetes mellitus. Its expected that participants, after a 6 month intervention, face to face and telephone, will improve their adherence to healthy behaviors related to diet and physical activity, their quality of life and the glycosylated hemoglobin figures.
Status | Completed |
Enrollment | 208 |
Est. completion date | March 31, 2023 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Be cared for by one of the nurses participating in the research team - Ability to complete the questionnaire - Sign the informed consent - Keep the Primary care health center during till the end of the research |
Country | Name | City | State |
---|---|---|---|
Spain | University of Oviedo | Oviedo | Asturias |
Lead Sponsor | Collaborator |
---|---|
University of Oviedo | Servicio de Salud del Principado de Asturias. Área Sanitaria III |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Diet recommendations (mean) | Compliance with dietary recommendations. We are going to use the Motiva.Diaf DM2 questionnaire. Includes 8 questions for dietary adherence. Response in dichotomous option 0 (do not follow the recommendation) or 1 (follow the recommendation). Total score range from 0 (worst dietary compliance) to 8 (best dietary compliance). | Change from Baseline dietary recommendations at 6 months | |
Primary | Change in Physical activity recommendations (mean) | Compliance with physical activity recommendations. We are going to use the Motiva.Diaf DM2 questionnaire. Includes 4 questions for physical activity recommendations. Response in dichotomous option 0 (do not follow the recommendation) or 1 (follow the recommendation). Total score range from 0 (worst dietary compliance) to 4 (best dietary compliance). Result: mean number of recommendations followed. |
Change from Baseline physical activity recommendations at 6 months | |
Secondary | Change in HbA1c (Mean percentage) | % of HbA1c | Change from Baseline % of HbA1c at 6 months |
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