Evaluation of the Translation of the DE-PLAN Program for the Primary Prevention of Type 2 Diabetes in Routine Primary Care

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility and effectiveness of the DE-PLAN Euskadi program for the primary prevention of type-II diabetes in high-risk population seen in primary care centers (Osakidetza-Basque Health Service) in which such intervention is implemented, compared to usual care control centers.

Detailed Description
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Objective: To evaluate the feasibility and effectiveness of the DE-PLANЄ program for the primary prevention of type-II diabetes in high-risk population seen in primary care centers (Osakidetza) in which such intervention is implemented, compared to usual care control centers. DESIGN AND METHODS: A phase IV cluster randomized prospective clinical trial, conducted in 14 primary care centers from Osakidetza, which will be randomly assigned to intervention or control group, that will collect a sample of 2534 followed for two years, aged 45 to 70 years without diabetes but with high risk of developing it (FINDRISC scale> 14), identified by a screening system. Nurses in intervention centers (GI) will implement DEPLANЄ for 12 months, a structured educational intervention on healthy lifestyles (diet and physical activity), while patients of the control centers will receive standard care for the prevention and treatment of type-II diabetes. ANALYSIS: The feasibility will be reported as the reach, adoption and implementation of the program. The attributable effectiveness of the program will be determined by comparing the changes in the incidence and risk of developing diabetes in healthy habits quality of life, observed in patients exposed to DE-PLANЄ intervention and of patients from control centers. The incremental cost-utility of DE-PLANЄ program will be also analysed.

Official Title
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Effectiveness of the Translation of a Type 2 Diabetes Primary Prevention Program in Routine Context of Primary Heath Care

Conditions
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Prediabetic State

Intervention / Treatment
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* Behavioral: DE-PLAN
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 45 to 70 years old high risk of developing type-II diabetes (Findrisc scale > 14 points) Exclusion Criteria: Disorders of the cardiovascular system Transplant recipients Renal or hepatic failure Severe chronic obstructive pulmonary disease Severe mental disorders Chronic and acute severe infections Metabolic uncontrolled disorders Restrictive pathology of muscles, bones and joints Complicated pregnancy Contact difficulties

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br> | Behavioral: DE-PLAN<br>* structured group or individual educational sessions (4 to 5) on diet and physical activity, plus ongoing reminder contacts (e-mails, sms, etc) during 1 year<br>|
| Active Comparator: control group<br> | Behavioral: Control group<br>* Standard advice for lifestyle change<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adoption of healthy lifestyles | Change in the adoption of minimum recommended levels of physical activity and fruit and vegetable consumption | 12 months | 
| Incidence of Diabetes | Effectiveness of the program in the reduction of the Incidence of Diabetes | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach of the program | Percentage of eligible participants exposed to the program | 24 months | 
| Implementation of the program | Extent in which the intervention components have been delivered as intended (intervention protocol) | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lifestyle, Prediabetic State, Patient Education, Primary Health Care