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

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ClinicalTrials.gov Identifier: NCT01365013
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : July 29, 2016
Information provided by (Responsible Party):
Carmen Silvestre Busto, Basque Health Service

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prediabetic State Behavioral: DE-PLAN Behavioral: Control group Phase 4

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : June 2011
Primary Completion Date : June 2013
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lifestyle counseling Behavioral: DE-PLAN
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

Primary Outcome Measures :
  1. Adoption of healthy lifestyles [ Time Frame: 12 months ]
    Change in the adoption of minimum recommended levels of physical activity and fruit and vegetable consumption

  2. Incidence of Diabetes [ Time Frame: 24 months ]
    Effectiveness of the program in the reduction of the Incidence of Diabetes

Secondary Outcome Measures :
  1. Reach of the program [ Time Frame: 24 months ]
    Percentage of eligible participants exposed to the program

  2. Implementation of the program [ Time Frame: 24 months ]
    Extent in which the intervention components have been delivered as intended (intervention protocol)

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365013

Primary Care Research Unit of Bizkaia
Bilbao, Spain, E48014
Sponsors and Collaborators
Basque Health Service
Principal Investigator: Carmen Silvestre Basque Health Service
Principal Investigator: Alvaro Sanchez Basque Health Service

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carmen Silvestre Busto, Nurse, Basque Health Service
ClinicalTrials.gov Identifier: NCT01365013     History of Changes
Other Study ID Numbers: 2010111039
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016

Keywords provided by Carmen Silvestre Busto, Basque Health Service:
Prediabetic State
Patient Education
Primary Health Care

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases