Program AACTIVE: African Americans Coming Together to Increase Vital Exercise
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in Hemoglobin A1C %
研究概览
简要总结
Program AACTIVE will enroll 80 African American/Black men with type 2 diabetes and depression. Participants will be randomized to either the intervention arm or the control arm. Participants in the intervention arm will receive counseling (cognitive behavioral therapy) and physical activity sessions over 12 weeks. Counseling and physical activity sessions will take place via a video conferencing platform. There will also be 3 in-person health assessments including baseline, at 12-weeks and 3-month follow up. The investigators are interested in seeing if physical activity and counseling improve A1C outcomes and depression symptoms for participants.
详细描述
Participants will be randomized to the Program AACTIVE intervention group or an Enhanced Usual Care (EUC) group. The intervention group will receive 10 sessions of cognitive behavioral therapy (CBT) and 6 physical activity sessions over the 12-week period. All Program AACTIVE CBT sessions and exercise sessions will run concurrently and take place virtually.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •African American/Black males, ambulatory status, diagnosed with type 2 diabetes for one year duration or longer, PHQ-9 score >=15 with no self-reported psychotic symptoms, live in the Wayne or Washtenaw Counties, have reliable transportation to in-person events, have reliable access to internet and a device that supports video calls.
排除标准
- •Stage 2 hypertension as defined by JNCVIII, recent cardiac events, recent laser surgery for proliferative retinopathy, history of stroke, lower limb amputation, peripheral neuropathy, aortic stenosis or other sever valvular heart disease, atrial fibrillation, severe COPD (e.g., basal oxygen), class III or IV heart failure or medical instability.
- •Participants who are currently receiving psychotherapy services for the treatment of depression from a mental health care provider will be excluded while participants who are currently receiving only medication management from as psychiatrist will be included.
结局指标
主要结局
Change in Hemoglobin A1C %
时间窗: baseline, 3-months (post intervention), 6-months (3-month follow up)
Finger poke
Blood Pressure
时间窗: baseline, 3-months (post intervention), 6-months (3-month follow up)
Digital Blood Pressure Machine measuring systolic and diastolic blood pressure. Blood pressures will be measured twice and averaged. The average will be recorded as the blood pressure reading.
Change in Depressive Symptoms
时间窗: baseline, 3-months (post intervention), 6-months (3-month follow up)
Patient Health Questionnaire-9 Scale, a scale to measure depression severity. Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression.
Heart Rate
时间窗: baseline, 3-months (post intervention), 6-months (3-month follow up)
Digital Blood Pressure Machine (with heart rate measure)
Physical Activity Minutes Each Week
时间窗: Weekly, for intervention period between baseline and 3 months (post intervention)
Minutes of physical activity each week logged in a physical activity log.
Number of Steps
时间窗: Weekly, for intervention period between baseline and 3 months (post intervention)
Fitbit (provided by the study) readings and physical activity log
次要结局
- Diabetes Quality of Life(baseline, 3-months (post intervention), 6-months (3-month follow up))
- General Quality of Life(baseline, 3-months (post intervention), 6-months (3-month follow up))
研究者
Jaclynn Hawkins
Associate Professor
University of Michigan