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

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ClinicalTrials.gov Identifier: NCT00717158
Recruitment Status : Completed
First Posted : July 16, 2008
Last Update Posted : July 16, 2008
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
University of Virginia

Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Obesity Behavioral: Usual medical care Behavioral: Lifestyle Case management

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official 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
Study Start Date : May 2001
Primary Completion Date : February 2003
Study Completion Date : February 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: I
Usual medical care. They received written healthy lifestyle information
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
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



Primary Outcome Measures :
  1. Health Care utilization and costs using claims data [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Weight change [ Time Frame: one year ]
  2. Change in hemoglobin A1c [ Time Frame: One Year ]
  3. Work days lost [ Time Frame: One year ]
  4. Disability Days [ Time Frame: One year ]
  5. Change in quality of life [ Time Frame: one year ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717158


Locations
United States, Virginia
University of Virginia School of Medicine
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Anne M Wolf, MS, RD University of Virginia School of Medicine

Publications:
Responsible Party: Anne Wolf, Principal Investigator, University of Virginia School of Medicine
ClinicalTrials.gov Identifier: NCT00717158     History of Changes
Other Study ID Numbers: 8742
Am Dietetic Assoc 9336
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: July 16, 2008
Last Verified: August 2007

Keywords provided by University of Virginia:
Health Behavior
Lifestyle
health care costs
quality of life

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases