Lifestyle Intervention's Impact on Health Care Costs

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717158
• Other study ID #: 8742
• Secondary ID: Am Dietetic Asso
• Status: Completed
• Phase: N/A
• First received: July 14, 2008
• Last updated: July 14, 2008
• Start date: May 2001
• Est. completion date: February 2003

Study information

• Verified date: August 2007
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: February 2003
• Est. primary completion date: February 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity

Intervention

Behavioral:
• Usual medical care

• 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

Locations

Country	Name	City	State
United States	University of Virginia School of Medicine	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Activi — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Care utilization and costs using claims data		one year	No
Secondary	Weight change		one year	No
Secondary	Change in hemoglobin A1c		One Year	No
Secondary	Work days lost		One year	No
Secondary	Disability Days		One year	No
Secondary	Change in quality of life		one year	No