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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
  Purpose

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 Intervention
Diabetes Mellitus, Type 2
Obesity
 Behavioral: Usual medical care
Behavioral: Lifestyle Case management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Health Care utilization and costs using claims data [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 147
Study Start Date: May 2001
Study Completion Date: February 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Project Homepage  This link exits the ClinicalTrials.gov site

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
Study First Received: July 14, 2008
Last Updated: July 14, 2008
Health Authority: United States: Institutional Review Board

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
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013