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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01365013
First Posted: June 3, 2011
Last Update Posted: July 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Carmen Silvestre Busto, Basque Health Service
  Purpose
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 Intervention Phase
Prediabetic State Behavioral: DE-PLAN Behavioral: Control group Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Carmen Silvestre Busto, Basque Health Service:

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

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


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

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


Enrollment: 1113
Study Start Date: June 2011
Study Completion Date: July 2015
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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
Criteria

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
  Contacts and Locations
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


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

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 Submitted: June 1, 2011
First Posted: June 3, 2011
Last Update Posted: July 29, 2016
Last Verified: July 2016

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

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