Type 2 Diabetes Prevention and Management for People With Serious Mental Illness: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Hours of Active and Sedentary Behavior
研究概览
简要总结
The goal of this clinical trial is to examine if it is feasible to randomly assign people into two groups and participate in Lifestyle MIND (Mental Illness and/N' Diabetes) at two different times. Lifestyle MIND is a diabetes lifestyle intervention recently developed for people with serious mental illness (SMI). It is known to be helpful for people with SMI who complete it, but the investigators do not know the effect in comparison to those who do not participate in it. The main questions it aims to answer are:
- Does Lifestyle MIND improve diabetes control among people with SMI?
- Will the effect of Lifestyle MIND be sustained 10 weeks after program completion?
- From the provider's perspective, what are the barriers of achieving optimal diabetes treatment outcomes for patients with SMI?
Researchers will compare outcomes of participants in the intervention with those in the wait-list control arm, to see if there will be significant differences in blood glucose level, compliance of diabetes self-management, time staying active, number of emergency department (ED) visits and psychiatric hospitalization, and subjective well-being.
详细描述
Specific Aims 1 and 2
Study Design:
The study team will do a study called a randomized wait-list control trial. This means the investigators will randomly choose who gets the program first and who waits. Those in the program group will get a 10-week Lifestyle MIND program and then join a self-help group for 10 weeks. The waitlist group will wait for 10 weeks and then get the 10-week Lifestyle MIND program.
Participants:
The study team will recruit 20 people from a program for homeless adults in San Antonio, TX, who often have serious mental illness (SMI). The study team will invite them to an information session to explain the study. After agreeing to join, participants will sign a form and give some basic information after which the study team will randomly assign them to either start the program right away or wait for 10 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of SMI
- •a diagnosis of T2DM, seeing a health care provider for T2DM, or having been informed by a healthcare provider for being pre-diabetic or diabetic
- •willingness to commit to participate for 20 weeks
- •ability to respond to self-report scales and questionnaires used in the study
排除标准
- •unable to perform the moderate intensity exercise program in Lifestyle MIND
研究组 & 干预措施
Intervention Arm
Lifestyle MIND
干预措施: Lifestyle MIND (Behavioral)
Wait-list control arm
Delayed Lifestyle MIND
干预措施: Lifestyle MIND (Behavioral)
结局指标
主要结局
Hours of Active and Sedentary Behavior
时间窗: Weeks 1, 10, and 20
This is measured by an ActiGraph device which participants will wear on their wrist for a week in Week 1, Week 10, and Week 20. Data of four consecutive days, including the weekend, will be used to calculate the number of hours a participant spends for active and sedentary behaviors. In older adults, the reliability of the ActiGraph measured during daily free-living activities ranged from moderate to excellent (interclass correlation coefficients \[ICC\]= .75-.89) across intensity categories (i.e., light and moderate intensities) and daily number of steps. In healthy middle-aged adults, the ActiGraph has shown moderate to excellent reliability (ICCs ranged from .74 to .90.
Hemoglobin A1c (HbA1c)
时间窗: Weeks 1, 10, and 20
This is a blood glucose test used to indicate a patient's average blood glucose level in the recent three months. It is a blood glucose measure that's not dominantly affected by the immediate physiological status (e.g., food intakes) at the time of blood drawn. An HbA1c level of 6.5% or higher is diabetic, 5.7 % to 6.4%, prediabetic, and below 5.7%, normal. We will coordinate with the study site and schedule a licensed nurse to take blood samples in designated weeks.
Satisfaction with Life Scale (SWLS)
时间窗: Weeks 1, 10, and 20
This is a 5-item self-report measure of subjective well-being, which is widely used in health research and has good psychometric properties confirmed with the population with SMI. The SWLS total score ranges from 5 to 35, and higher scores indicate better subject well-being. The Spanish translation of SWLS is available upon request.
Number of emergency department (ED) visits and psychiatric hospitalizations
时间窗: Weeks 1, 10, and 20
ED visits and psychiatric hospitalizations are often the result of poorly managed illness conditions. We will record self-report numbers of ED visits and psychiatric hospitalizations one year before and during the study period.
Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire
时间窗: Weeks 1, 10, and 20
This is a self-report questionnaire with 11 items to measure a participant's compliance with diabetes self-management including diet, exercise, blood glucose tests, foot care, and smoking status. This questionnaire has been commonly used in diabetes lifestyle intervention studies with good validity and reliability. The Spanish version of this questionnaire is available upon request. Each of the first 10 items is scored on a five-point Likert scale indicating the frequency of the specified behavior as 0 = never to 4 = always. The range of possible scores is 0-40 with a higher score indicating better self management.
次要结局
未报告次要终点