Lifestyle Intervention's Impact on Health Care Costs (ICAN)
Primary Purpose
Diabetes Mellitus, Type 2, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual medical care
Lifestyle Case management
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring Health Behavior, Lifestyle, health care costs, quality of life
Eligibility 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
Sites / Locations
- University of Virginia School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
I
2
Arm Description
Usual medical care. They received written healthy lifestyle information
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
Outcomes
Primary Outcome Measures
Health Care utilization and costs using claims data
Secondary Outcome Measures
Weight change
Change in hemoglobin A1c
Work days lost
Disability Days
Change in quality of life
Full Information
NCT ID
NCT00717158
First Posted
July 14, 2008
Last Updated
July 14, 2008
Sponsor
University of Virginia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00717158
Brief Title
Lifestyle Intervention's Impact on Health Care Costs
Acronym
ICAN
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 Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
February 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Virginia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Obesity
Keywords
Health Behavior, Lifestyle, health care costs, quality of life
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
No Intervention
Arm Description
Usual medical care. They received written healthy lifestyle information
Arm Title
2
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Usual medical care
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Case management
Intervention Description
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 Measure Information:
Title
Health Care utilization and costs using claims data
Time Frame
one year
Secondary Outcome Measure Information:
Title
Weight change
Time Frame
one year
Title
Change in hemoglobin A1c
Time Frame
One Year
Title
Work days lost
Time Frame
One year
Title
Disability Days
Time Frame
One year
Title
Change in quality of life
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne M Wolf, MS, RD
Organizational Affiliation
University of Virginia School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia School of Medicine
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15220230
Citation
Wolf AM, Conaway MR, Crowther JQ, Hazen KY, L Nadler J, Oneida B, Bovbjerg VE; Improving Control with Activity and Nutrition (ICAN) Study. Translating lifestyle intervention to practice in obese patients with type 2 diabetes: Improving Control with Activity and Nutrition (ICAN) study. Diabetes Care. 2004 Jul;27(7):1570-6. doi: 10.2337/diacare.27.7.1570.
Results Reference
result
PubMed Identifier
17659904
Citation
Wolf AM, Siadaty M, Yaeger B, Conaway MR, Crowther JQ, Nadler JL, Bovbjerg VE. Effects of lifestyle intervention on health care costs: Improving Control with Activity and Nutrition (ICAN). J Am Diet Assoc. 2007 Aug;107(8):1365-73. doi: 10.1016/j.jada.2007.05.015.
Results Reference
result
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Lifestyle Intervention's Impact on Health Care Costs
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