Diet and Physical Activity Program for Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of a Primary Care Diet and Physical Activity Educational Program for Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group (IG)<br>Completing the consent and the pre-intervention questionnaires, anthropometric and HbA1c measurements. Dietary and/ or physical activity: face to face plus written material 3 months later: motivational phone call. | Behavioral: Intervention<br>* Dietary and/ or physical activity: face to face plus written material (at baseline) 3 months later: motivational phone call.<br>|
| No Intervention: Control group (CG)<br>Completing the consent and the pre-intervention questionnaires, anthropometric and HbA1c measurements. Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (Mean percentage) | % of HbA1c | Change from Baseline % of HbA1c at 6 months |