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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 October 2012
Main ID:  NCT00717158
Date of registration: 14/07/2008
Primary sponsor: University of Virginia
Public title: Lifestyle Intervention's Impact on Health Care Costs ICAN
Scientific title: Evaluating Healthcare Utilization, Costs and Health-Related Outcomes of a Medical Nutrition Therapy Intervention on Obese Patients With Type 2 Diabetes - A Pilot Study
Date of first enrolment: May 2001
Target sample size: 147
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention  
Countries of recruitment
Key inclusion & exclusion criteria

Inclusion Criteria:

- BMI > 30 kg/m2, calculated from measured weight and height.

- Type 2 diabetics on medication for their diabetes.

- Age 20 -60 years of age.

- Have phone.

- Fluency in reading, writing and comprehension of English

- Have Qualchoice as their primary health insurer.

Exclusion Criteria:

- Depression, BDI score > 20

- Pregnancy

Age minimum: 20 Years
Age maximum: 60 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Diabetes Mellitus, Type 2
Behavioral: Lifestyle Case management
Behavioral: Usual medical care
Primary Outcome(s)
Health Care utilization and costs using claims data [Time Frame: one year]
Secondary Outcome(s)
Change in hemoglobin A1c [Time Frame: One Year]
Change in quality of life [Time Frame: one year]
Disability Days [Time Frame: One year]
Weight change [Time Frame: one year]
Work days lost [Time Frame: One year]
Secondary ID(s)
Am Dietetic Assoc 9336
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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