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

University of Virginia

Status: Completed

Conditions: Obesity; Diabetes Mellitus, Type 2

Treatments: Behavioral: Lifestyle Case management; Behavioral: Usual medical care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00717158

Am Dietetic Assoc 9336

8742

Details and patient eligibility

About

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.

Enrollment: 147 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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147 participants in 2 patient groups

I

No Intervention group

Description:

Usual medical care. They received written healthy lifestyle information

Treatment:

Behavioral: Usual medical care

2

Active Comparator group

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

Treatment:

Behavioral: Lifestyle Case management