Diabetes Prevention in Prediabetic Patients (DPEP)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by Meir Medical Center
Sponsor:
Collaborator:
Clalit Health Services
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01659697
First received: August 5, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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).


Condition Intervention
Ethnic Group
Young Adults
Prediabetes
Community Health Services
Behavioral: intensive lifestyle counseling

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Diabetes Prevention in Patients Aged 25-55 From Ethiopian Origin With Prediabetes: Evaluation of Feasibility and Efficacy of Intensive or Less Intensive Lifestyle Intervention

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • occurence of diabetes [ Time Frame: two years period ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • change in Body Mass index and Physical activity [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • prediabetes
  • age 25-55
  • ethiopian origin

Exclusion Criteria:

  • diabetes
  • age under 25 or above 55
  • non ethiopian origin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659697

Contacts
Contact: Joelle S Singer, M.D. +972506263652 jsinger@clalit.org.il
Contact: Dalia Blumenthal, M.D. +972523583372 blumed@bezeqint.net

Locations
Israel
Central district Clalit Health Services
Rishon Le Zion, Israel
Sponsors and Collaborators
Meir Medical Center
Clalit Health Services
Investigators
Principal Investigator: Joelle A Singer, M.D. Meir Medical Center
Study Director: Dalia Blumenthal, M.D. Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01659697     History of Changes
Other Study ID Numbers: 057/2012
Study First Received: August 5, 2012
Last Updated: August 5, 2012
Health Authority: Israel: Clalit Health Services

Keywords provided by Meir Medical Center:
lifestyle
diabetes prevention
BMI
physical activity

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

ClinicalTrials.gov processed this record on September 22, 2014