Evaluation of the Translation of the DE-PLAN Program for the Primary Prevention of Type 2 Diabetes in Routine Primary Care (DE-PLAN E)
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.
Behavioral: Control group
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effectiveness of the Translation of a Type 2 Diabetes Primary Prevention Program in Routine Context of Primary Heath Care|
- Adoption of healthy lifestyles [ Time Frame: 12 months ] [ Designated as safety issue: No ]Change in the adoption of minimum recommended levels of physical activity and fruit and vegetable consumption
- Incidence of Diabetes [ Time Frame: 24 months ] [ Designated as safety issue: No ]Effectiveness of the program in the reduction of the Incidence of Diabetes
- Reach of the program [ Time Frame: 24 months ] [ Designated as safety issue: No ]Percentage of eligible participants exposed to the program
- Implementation of the program [ Time Frame: 24 months ] [ Designated as safety issue: No ]Extent in which the intervention components have been delivered as intended (intervention protocol)
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||June 2015|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
|Experimental: Lifestyle counseling||
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
|Active Comparator: control group||
Behavioral: Control group
Standard advice for lifestyle change
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365013
|Contact: Alvaro Sanchez, PhD||+34 firstname.lastname@example.org|
|Contact: Gonzalo Grandes, MD, MS||+34 email@example.com|
|Primary Care Research Unit of Bizkaia||Recruiting|
|Bilbao, Spain, E48014|
|Contact: Alvaro Sanchez|
|Principal Investigator:||Carmen Silvestre||Basque Health Service|
|Principal Investigator:||Alvaro Sanchez||Basque Health Service|