Lifestyle Intervention's Impact on Health Care Costs

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Obesity
• Interventions: Behavioral: Usual medical care; Behavioral: Lifestyle Case management

• Registration Number: NCT00717158
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05
• Primary Completion: 2003-02
• Study Completion: 2003-02
• Status Verified: 2007-08
• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-14
• Last Update Submitted: 2008-07-14
• Study First Posted: 2008-07-16
• Last Update Posted: 2008-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	Usual medical care	Usual medical care. They received written healthy lifestyle information
2	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

Name	Time	Method
Health Care utilization and costs using claims data	one year

Secondary Outcome Measures

Name	Time	Method
Weight change	one year
Change in hemoglobin A1c	One Year
Work days lost	One year
Disability Days	One year
Change in quality of life	one year

Trial Locations

Locations (1)

University of Virginia School of Medicine; 🇺🇸 Charlottesville, Virginia, United States