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

This study has been completed.
Sponsor:
Collaborator:
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:


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
Investigators
Principal Investigator: Anne M Wolf, MS, RD University of Virginia School of Medicine
  More Information

Additional Information:
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 April 14, 2014