Lifestyle Intervention's Impact on Health Care Costs

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating Healthcare Utilization, Costs and Health-Related Outcomes of a Medical Nutrition Therapy Intervention on Obese Patients With Type 2 Diabetes - A Pilot Study

Conditions
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Diabetes Mellitus, Type 2, Obesity

Intervention / Treatment
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* Behavioral: Usual medical care
* Behavioral: Lifestyle Case management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: I<br>Usual medical care. They received written healthy lifestyle information | Behavioral: Usual medical care<br> <br> |
| Active Comparator: 2<br>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 | Behavioral: Lifestyle Case management<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Care utilization and costs using claims data |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Behavior, Lifestyle, health care costs, quality of life