DPEP: Diabetes Prevention in Prediabetic Patients

• Sponsor: Meir Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01659697
• Collaborator: Clalit Health Services (Other)
• Enrollment: 200
• Location: 1
• Duration (Months): 35
• Patients Per Site Per Month: 5.7

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Ethnic Group; Young Adults; Prediabetes; Community Health Services	Behavioral: intensive lifestyle counseling

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• 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
• Study Start Date: Aug 1, 2012
• Anticipated Primary Completion Date: Dec 1, 2014
• Anticipated Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. change in Body Mass index and Physical activity [two years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• prediabetes

• age 25-55

• ethiopian origin

Exclusion Criteria:

• diabetes

• age under 25 or above 55

• non ethiopian origin

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Meir Medical Center
• ClinicalTrials.gov Identifier: NCT01659697
• Other Study ID Numbers: 057/2012
• First Posted: Aug 8, 2012
• Last Update Posted: Aug 8, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by Meir Medical Center: lifestyle; diabetes prevention; BMI; physical activity
• Additional relevant MeSH terms: Prediabetic State; Glucose Intolerance

Study Results

No Results Posted as of Aug 8, 2012