Michigan Men's Diabetes Project 3 (MenD 3): Mind and Motion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in A1C
研究概览
简要总结
The Michigan Men's Diabetes Project III: Mind & Motion is an 7-month pilot randomized clinical trial. The investigators are looking to recruit 80 Black men with type 2 diabetes (T2D) (need to have diagnosis for at least one year) that are over the age of 18. Participants also must be under the care of a physician for their diabetes, self report an Hemoglobin A1c (A1C) of 7.0% or more in the last year, be willing to participate in study events (weekly physical activity, exercise and Cognitive Behavioral Therapy (CBT) sessions, group discussion sessions, and in-person health assessments), have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet/phone/computer to complete study related tasks, live in the Wayne or Washtenaw County, and have reliable transportation to in-person events. All participants will receive 8 hours/sessions of cognitive behavioral therapy. Participants randomized to the intervention arm will also receive 8 sessions of guided exercise at the same time. Following that they will also receive 8 group discussion sessions that will serve as on-going support. All sessions will be help via Zoom. Additionally, all participants will participate in The 4 health assessments will take place at baseline, 10 weeks, 18 weeks, and 30 weeks.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •African American/Black males
- •age 18 years or older
- •ambulatory status
- •diagnosis of Type 2 Diabetes (T2D) for one year duration or longer
- •be under the care of a physician for their diabetes, self report an A1C of 7.0% or more in the last year
- •be willing to participate in study events (weekly physical activity, exercise and CBT sessions, group discussion sessions, and in-person health assessments)
- •have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet/phone/computer to complete study related tasks
- •live in the Wayne or Washtenaw County\
- •have reliable transportation to in-person events
排除标准
- •stage 2 hypertension as defined by Joint National Committee (JNC) VIII
- •recent cardiac events
- •recent laser surgery for proliferative retinopathy
- •history of stroke
- •lower limb amputation
- •peripheral neuropathy
- •severe Chronic Obstructive Pulmonary Disease (COPD) (e.g., basal oxygen)
- •class III or IV heart failure
- •medical instability.
- •Per American College of Sports Medicine (ACSM) guidelines, medical exclusion criteria will also include currently experiencing:
- •ongoing unstable angina
- •uncontrolled cardiac arrhythmia with hemodynamic compromise
- •active endocarditis
- •symptomatic severe aortic stenosis
- •acute myocarditis or pericarditis
- •acute aortic dissection
- •acute pulmonary embolism
- •pulmonary infarction
- •deep venous thrombosis
- •physical disability that precludes safe and adequate testing
- •chest discomfort with exertion
- •unreasonable breathlessness, or dizziness, fainting, or blackouts.
- •As part of the screening process, the investigators will ask the participant to self-report on these conditions. Participants who are currently receiving psychotherapy services for the treatment of depression from a mental health provider will be excluded. Participants who are currently receiving only medication management from a psychiatrist will be included.
- •If you are interested in the study, please complete our screening survey: https://redcapproduction.umms.med.umich.edu/surveys/?s=JNPPEDANX7KLPPF
- •Thank you so much!
研究组 & 干预措施
Intervention Group
Participants randomized to the intervention group will receive 8 one hour virtual sessions of individual cognitive behavioral therapy (CBT) that will take place via U-M Zoom, which is a HIPAA compliant virtual conferencing platform.
Participants in this group will also receive 8 one hour virtual sessions of individual exercise.
Participants in this group will also receive 8 one hour virtual group discussion sessions that will serve as on-going support. This group (4-8 participants) discussion will be facilitated by one CBT Interventionist and one Exercise Interventionist. These sessions will take place following the individual sessions of CBT and Exercise.
干预措施: Cognitive Behavioral Therapy (Behavioral)
Intervention Group
Participants randomized to the intervention group will receive 8 one hour virtual sessions of individual cognitive behavioral therapy (CBT) that will take place via U-M Zoom, which is a HIPAA compliant virtual conferencing platform.
Participants in this group will also receive 8 one hour virtual sessions of individual exercise.
Participants in this group will also receive 8 one hour virtual group discussion sessions that will serve as on-going support. This group (4-8 participants) discussion will be facilitated by one CBT Interventionist and one Exercise Interventionist. These sessions will take place following the individual sessions of CBT and Exercise.
干预措施: Exercise (Behavioral)
Intervention Group
Participants randomized to the intervention group will receive 8 one hour virtual sessions of individual cognitive behavioral therapy (CBT) that will take place via U-M Zoom, which is a HIPAA compliant virtual conferencing platform.
Participants in this group will also receive 8 one hour virtual sessions of individual exercise.
Participants in this group will also receive 8 one hour virtual group discussion sessions that will serve as on-going support. This group (4-8 participants) discussion will be facilitated by one CBT Interventionist and one Exercise Interventionist. These sessions will take place following the individual sessions of CBT and Exercise.
干预措施: Group Discussions - Ongoing Support (Behavioral)
Control Group
Participants randomized to the control group will receive enhanced usual care (EUC). The EUC group will receive 8 sessions of standard Cognitive Behavioral Therapy.
干预措施: Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Change in A1C
时间窗: Screening, Baseline, 10 weeks, 18 weeks, 30 weeks
Anthropometric/clinical data
Change in General Quality of Life (12-Item Short Form Survey (SF-12))
时间窗: Baseline, 10 weeks, 18 weeks, 30 weeks
Survey Data - 12 questions covering physical and mental health domains - Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Change in Diabetes-Related Distress (The Type 2 Diabetes Distress Assessment System)
时间窗: Baseline, 10 weeks, 18 weeks, 30 weeks
Survey Data - The assessment system has two components: The Core Distress Scale and The Sources Scale. The CORE DISTRESS SCORE is simply the average of the 8 items of the CORE SCALE, with each item rated on a 1 to 5 scale: Mean score \< 2.0 indicate little or no distress, Mean score between 2.0 and 2.9 indicate moderate distress, Mean score \> 3.0 indicate high distress. The Sources scale aims to find the sources of the distress, whether CORE DISTRESS is high or low, it is helpful to identify those aspects of living with diabetes that are contributing to the individual's diabetes distress.
Change in Diabetes Quality of Life (Diabetes Quality of Life Instrument)
时间窗: Baseline, 10 weeks, 18 weeks, 30 weeks
Survey Data - Survey answers range for each section of the survey asking about satisfaction, worry, and impact of diabetes. The DQoL measure consists of 46 items ranked on a 5-point Likert scale. Individual domain and DQoL total scores range from 0 (lowest possible QoL) to 100 (highest possible QoL).
次要结局
- Change in Diabetes Self-Efficacy (Perceived Diabetes Self-Management Scale)(Baseline, 10 weeks, 18 weeks, 30 weeks)
研究者
Jaclynn Hawkins
Assistant Professor
University of Michigan