Diabetes Mellitus, Type 2, Obesity
Conditions
Keywords
Health Behavior, Lifestyle, health care costs, quality of life
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.
Interventions
BEHAVIORALUsual medical care
BEHAVIORALLifestyle 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
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Health Care utilization and costs using claims data | one year |
Secondary
| Measure | Time frame |
|---|---|
| Work days lost | One year |
| Disability Days | One year |
| Change in quality of life | one year |
| Change in hemoglobin A1c | One Year |
| Weight change | one year |
Countries
United States
Outcome results
None listed