Evaluation of the Translation of the DE-PLAN Program for the Primary Prevention of Type 2 Diabetes in Routine Primary Care
NCT ID: NCT01365013
Last Updated: 2016-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
1113 participants
INTERVENTIONAL
2011-06-30
2015-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Optimizing the Primary Prevention of Type-2 Diabetes in Primary Health Care
NCT03254979
Diabetes in Europe - Prevention Using Lifestyle, Physical Activity and Nutritional Intervention in Catalonia
NCT01519505
Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs
NCT05056376
Soccer-based Adaptation of the Diabetes Prevention Program
NCT03595384
Effectiveness of PRECEDE Model for Health Education on Changes and Level of Control in Patients With Type 2 Diabetes Mellitus
NCT01316367
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lifestyle counseling
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
control group
Control group
Standard advice for lifestyle change
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Control group
Standard advice for lifestyle change
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* high risk of developing type-II diabetes (Findrisc scale \> 14 points)
Exclusion Criteria
* 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
45 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Basque Health Service
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Carmen Silvestre Busto
Nurse
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carmen Silvestre
Role: PRINCIPAL_INVESTIGATOR
Basque Health Service
Alvaro Sanchez
Role: PRINCIPAL_INVESTIGATOR
Basque Health Service
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Primary Care Research Unit of Bizkaia
Bilbao, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sanchez A, Silvestre C, Campo N, Grandes G; PreDE research group. Type-2 diabetes primary prevention program implemented in routine primary care: a process evaluation study. Trials. 2016 May 20;17(1):254. doi: 10.1186/s13063-016-1379-0.
Sanchez A, Silvestre C, Sauto R, Martinez C, Grandes G; PreDE research group. Feasibility and effectiveness of the implementation of a primary prevention programme for type 2 diabetes in routine primary care practice: a phase IV cluster randomised clinical trial. BMC Fam Pract. 2012 Nov 16;13:109. doi: 10.1186/1471-2296-13-109.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010111039
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.