Diabetes Prevention in Prediabetic Patients (DPEP)

August 5, 2012 updated by: Meir Medical Center

Diabetes Prevention in Patients Aged 25-55 From Ethiopian Origin With Prediabetes: Evaluation of Feasibility and Efficacy of Intensive or Less Intensive Lifestyle Intervention

This study will evaluate the feasibility and efficacy of two interventions of lifestyle ( intensive and less intensive) to prevent diabetes in patients from Ethiopian origin, aged 25 to 55 years old with prediabetes living in Israel and insured by Clalit Health Services in the Central district, using resources existing in this Health Care system (HMO).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Rishon Le Zion, Israel
        • Central district Clalit Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients aged 25-55 from Ethiopian origin leaving in Israel with pre diabetes

Description

Inclusion Criteria:

  • prediabetes
  • age 25-55
  • ethiopian origin

Exclusion Criteria:

  • diabetes
  • age under 25 or above 55
  • non ethiopian origin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intensive Lifestyle counseling
Behavioral: intensive lifestyle counseling
Intensive lifestyle counseling will include a bi annual visit of the primary physician and nurse, a group intervention about use of medical resources, healthy lifestyle a one to one intervention with a dietician about diet and a one to one intervention with a physiotherapist about exercise
usual lifestyle counseling
Behavioral: intensive lifestyle counseling
Intensive lifestyle counseling will include a bi annual visit of the primary physician and nurse, a group intervention about use of medical resources, healthy lifestyle a one to one intervention with a dietician about diet and a one to one intervention with a physiotherapist about exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurence of diabetes
Time Frame: two years period
Patients included in the study will have a one year lifestyle intervention ( two arms: intensive, less intensive) and will be followed for two years for the occurence of diabetes
two years period

Secondary Outcome Measures

Outcome Measure
Time Frame
change in Body Mass index and Physical activity
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Collaborators

Clalit Health Services

Investigators

  • Principal Investigator: Joelle A Singer, M.D., Meir Medical Center
  • Study Director: Dalia Blumenthal, M.D., Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

July 1, 2015

Study Registration Dates

First Submitted

August 5, 2012

First Submitted That Met QC Criteria

August 5, 2012

First Posted (ESTIMATE)

August 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 8, 2012

Last Update Submitted That Met QC Criteria

August 5, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 057/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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