Virtual World Health Behavior Counseling for Patients With Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Change from Baseline in hemoglobin a1c at 8 weeks after completion of the intervention.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
face to face
face to face method of health education
干预措施: face to face (Behavioral)
Virtual world
Virtual world delivery method
干预措施: virtual world (Behavioral)
结局指标
主要结局
Change from Baseline in hemoglobin a1c at 8 weeks after completion of the intervention.
时间窗: Baseline and 8 weeks after completion of the intervention
次要结局
- Change from Baseline in physical activity at 8 weeks after completion of the intervention.(Baseline and 8 weeks after completion of the intervention)
- Change from Baseline in dietary patterns at 8 weeks after completion of the intervention.(Baseline and 8 weeks after completion of the intervention)