Clinical trial NCT01340079: Virtual World Health Behavior Counseling for Patients With Diabetes
Official title: Virtual World Health Behavior Counseling for Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes
Keywords: diabetes mellitus, non-insulin dependent
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
First posted: 2011-04-22
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in hemoglobin a1c at 8 weeks after completion of the intervention.
timeFrame: Baseline and 8 weeks after completion of the intervention
Secondary outcomes:
measure: Change from Baseline in dietary patterns at 8 weeks after completion of the intervention.
timeFrame: Baseline and 8 weeks after completion of the intervention
measure: Change from Baseline in physical activity at 8 weeks after completion of the intervention.
timeFrame: Baseline and 8 weeks after completion of the intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center/Boston University Medical Campus
name: John M. Wiecha, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts, Worcester
name: Milagros Rosal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosal MC, Heyden R, Mejilla R, Capelson R, Chalmers KA, Rizzo DePaoli M, Veerappa C, Wiecha JM. A Virtual World Versus Face-to-Face Intervention Format to Promote Diabetes Self-Management Among African American Women: A Pilot Randomized Clinical Trial. JMIR Res Protoc. 2014 Oct 24;3(4):e54. doi: 10.2196/resprot.3412.