Diabetes Prevention in Prediabetic Patients

• Conditions: Ethnic Group; Young Adults; Prediabetes; Community Health Services
• Interventions: Behavioral: intensive lifestyle counseling

• Registration Number: NCT01659697
• Lead Sponsor: Meir Medical Center

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-08
• Study Start: 2012-08
• Study First Submitted: 2012-08-05
• Study First Submitted QC: 2012-08-05
• Last Update Submitted: 2012-08-05
• Study First Posted: 2012-08-08
• Last Update Posted: 2012-08-08
• Primary Completion: 2014-12
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• prediabetes
• age 25-55
• ethiopian origin

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intensive Lifestyle counseling	intensive lifestyle counseling	-
usual lifestyle counseling	intensive lifestyle counseling	-

Primary Outcome Measures

Name	Time	Method
occurence of diabetes	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

Secondary Outcome Measures

Name	Time	Method
change in Body Mass index and Physical activity	two years

Trial Locations

Locations (1)

Central district Clalit Health Services; 🇮🇱 Rishon Le Zion, Israel