NCT01365013

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,113

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

June 1, 2011

Last Update Submit

July 28, 2016

Conditions

Prediabetic State

Keywords

LifestylePrediabetic StatePatient EducationPrimary Health Care

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Reach of the program

    24 months

  • Implementation of the program

    24 months

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL
Behavioral: DE-PLAN

control group

ACTIVE COMPARATOR
Behavioral: Control group

Interventions

DE-PLANBEHAVIORAL

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

Lifestyle counseling
Control groupBEHAVIORAL

Standard advice for lifestyle change

control group

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 70 years old
  • high risk of developing type-II diabetes (Findrisc scale \> 14 points)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Care Research Unit of Bizkaia

Bilbao, E48014, Spain

Location

Related Publications (2)

  • 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.

    PMID: 27206733DERIVED

  • 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.

    PMID: 23158830DERIVED

MeSH Terms

Conditions

Prediabetic State

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Carmen Silvestre

    Basque Health Service

    PRINCIPAL INVESTIGATOR

  • Alvaro Sanchez

    Basque Health Service

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

June 1, 2011

First Posted

June 3, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2013

Study Completion

July 1, 2015

Last Updated

July 29, 2016

Record last verified: 2016-07

Locations

ES(1)