Virtual World Health Behavior Counseling for Patients With Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Virtual World Health Behavior Counseling for Patients With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340079
• Other study ID #: 1RC1LM010412-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 16, 2011
• Last updated: September 20, 2012
• Start date: April 2011
• Est. completion date: July 2012

Study information

• Verified date: May 2012
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosed with T2DM

2. HbA1c level >= 8.0

3. 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

4. African-American origin

5. >= 18 years old

6. Telephone in home or easy access to one

7. Able to understand and participate in the study protocol

8. Functionally capable of meeting the activity goals

9. Understands and can provide informed consent

10. Physician approval to participate in the study.

Exclusion Criteria:

1. History of diabetic ketoacidosis

2. Gestational diabetes

3. Unable or unwilling to provide informed consent

4. Plans to move out of the area within the 12-month study period

5. Required intermittent glucocorticoid therapy within the past 3 months

6. Experienced an acute coronary event (myocardial infarction or unstable angina) within the previous 6 months

7. Has a medical condition that precludes adherence to study dietary recommendations (e.g., Crohn's disease, ulcerative colitis, end-stage renal disease)

8. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Behavioral:
• virtual world
health education using virtual world Second Life
• face to face
health education delivered in face to face groups

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in hemoglobin a1c at 8 weeks after completion of the intervention.		Baseline and 8 weeks after completion of the intervention	No
Secondary	Change from Baseline in dietary patterns at 8 weeks after completion of the intervention.		Baseline and 8 weeks after completion of the intervention	No
Secondary	Change from Baseline in physical activity at 8 weeks after completion of the intervention.		Baseline and 8 weeks after completion of the intervention	No