Diabetes Prevention in Prediabetic Patients
DPEP
Diabetes Prevention in Patients Aged 25-55 From Ethiopian Origin With Prediabetes: Evaluation of Feasibility and Efficacy of Intensive or Less Intensive Lifestyle Intervention
1 other identifier
observational
200
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2012
Typical duration for all trials
1 active site
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
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 5, 2012
CompletedFirst Posted
Study publicly available on registry
August 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedAugust 8, 2012
August 1, 2012
2.3 years
August 5, 2012
August 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
occurence of diabetes
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 Outcomes (1)
change in Body Mass index and Physical activity
two years
Study Arms (2)
Intensive Lifestyle counseling
usual lifestyle counseling
Interventions
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 Criteria
patients aged 25-55 from Ethiopian origin leaving in Israel with pre diabetes
You may qualify if:
- prediabetes
- age 25-55
- ethiopian origin
You may not qualify if:
- diabetes
- age under 25 or above 55
- non ethiopian origin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Meir Medical Centerlead
- Clalit Health Servicescollaborator
Study Sites (1)
Central district Clalit Health Services
Rishon LeZiyyon, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joelle A Singer, M.D.
Meir Medical Center
- STUDY DIRECTOR
Dalia Blumenthal, M.D.
Meir Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- FAMILY BASED
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2012
First Posted
August 8, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2014
Study Completion
July 1, 2015
Last Updated
August 8, 2012
Record last verified: 2012-08