Virtual World Health Behavior Counseling for Patients With Diabetes

Study Overview
=================
Brief Summary
-----------------
Comparison of 2 methods of delivery health education for African-American women with Type 2 Diabetes. The two methods are: face to face education in small groups, as compared to delivering the same curriculum in the virtual world, Second Life.

Detailed Description
-----------------
This study will provide health education to African-American women with type 2 diabetes either face to face, or using the Internet. The study seeks to determine how feasible the internet method is for this type of health education, and how it compares to the face to face method. Patients will be recruited from Boston Medical Center. They will do baseline surveys and have blood drawn. They will then be randomized into receiving their diabetes education in a face to face group at BMC, or receiving it online while at home. The online group will receive a computer to access the Internet program and Internet access. Both groups will participate in 8 diabetes education groups, and 4 individual counseling sessions. Subjects will complete surveys before and after the study to measure changes in physical activity, diet, and use of medications, and will have blood tests drawn at BMC before and after the study to measure changes in diabetes control, cholesterol. They will also have blood pressure measured before and after the study period.

Official Title
-----------------
Virtual World Health Behavior Counseling for Patients With Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: virtual world
* Behavioral: face to face


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with T2DM HbA1c level >= 8.0 Currently treated with diet, oral hypoglycemics or insulin. If currently on insulin, must have a history of prior therapy with diet alone or oral hypoglycemic agents African-American origin >= 18 years old Telephone in home or easy access to one Able to understand and participate in the study protocol Functionally capable of meeting the activity goals Understands and can provide informed consent Physician approval to participate in the study. Exclusion Criteria: History of diabetic ketoacidosis Gestational diabetes Unable or unwilling to provide informed consent Plans to move out of the area within the 12-month study period Required intermittent glucocorticoid therapy within the past 3 months Experienced an acute coronary event (myocardial infarction or unstable angina) within the previous 6 months Has a medical condition that precludes adherence to study dietary recommendations (e.g., Crohn's disease, ulcerative colitis, end-stage renal disease) Has a medical or psychiatric illness (i.e., dementia, psychiatric hospitalization or suicidality within past 5 years or takes an neuroleptic medication). We will not exclude based on history of depression or anxiety or taking anti-depressants or anti-anxiety medications.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual world<br>Virtual world delivery method | Behavioral: virtual world<br>* health education using virtual world Second Life<br>|
| Active Comparator: face to face<br>face to face method of health education | Behavioral: face to face<br>* health education delivered in face to face groups<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in hemoglobin a1c at 8 weeks after completion of the intervention. |  | Baseline and 8 weeks after completion of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in dietary patterns at 8 weeks after completion of the intervention. |  | Baseline and 8 weeks after completion of the intervention | 
| Change from Baseline in physical activity at 8 weeks after completion of the intervention. |  | Baseline and 8 weeks after completion of the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes mellitus, non-insulin dependent