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Lifestyle Intervention's Impact on Health Care Costs (ICAN)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00717158
First received: July 14, 2008
Last updated: NA
Last verified: August 2007
History: No changes posted

July 14, 2008
July 14, 2008
May 2001
February 2003   (final data collection date for primary outcome measure)
Health Care utilization and costs using claims data [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Weight change [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Change in hemoglobin A1c [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Work days lost [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Disability Days [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Change in quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Lifestyle Intervention's Impact on Health Care Costs
Evaluating Healthcare Utilization, Costs and Health-Related Outcomes of a Medical Nutrition Therapy Intervention on Obese Patients With Type 2 Diabetes - A Pilot Study

The ICAN Pilot project aims to evaluate the differences in economic, clinical and quality of life outcomes of a nutrition intervention involving lifestyle case management and medical nutrition therapy by a registered dietitian compared to usual medical care in obese persons with type 2 diabetes. The intervention is aimed at moderate weight loss (> 5-10%), improvement in diet quality and an increase in physical activity.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
  • Diabetes Mellitus, Type 2
  • Obesity
  • Behavioral: Usual medical care
  • Behavioral: Lifestyle Case management
    Intervention participants were assigned to one registered dietitian who they met with over a one year period for 6 session (four hours) of individual care, 6- one-hour group classes, and had monthly email contact for follow up and checking in
  • No Intervention: I
    Usual medical care. They received written healthy lifestyle information
    Intervention: Behavioral: Usual medical care
  • Active Comparator: 2
    Intervention participants were assigned to one registered dietitian who they met with over a one year period for 6 session (four hours) of individual care, 6- one-hour group classes, and had monthly email contact for follow up and checking in
    Intervention: Behavioral: Lifestyle Case management

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
February 2003
February 2003   (final data collection date for primary outcome measure)

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
Both
20 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00717158
8742, Am Dietetic Assoc 9336
No
Anne Wolf, Principal Investigator, University of Virginia School of Medicine
University of Virginia
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Anne M Wolf, MS, RD University of Virginia School of Medicine
University of Virginia
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP