Building Self-regulation Capacity in AA T2DM Women: Feasibility of an Ecological Momentary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Number of times participants accessed their CGM data
研究概览
简要总结
In African-Americans, the incidence of type 2 diabetes (T2DM) is ~14%. Adherence to crucial diabetes self-management (DSM) behaviors, such as engaging in physical activity (PA) is dangerously low among AA women living in disadvantaged neighborhoods. These women manage numerous chronic challenges (daily discrimination, poverty, and violence), which drain the internal energy needed for DSM. The ability to self-regulate (modify one's behaviors based on the requirements of a situation) has been associated with adherence to health behaviors, including diet and PA. This 6-week ecological momentary intervention (EMI) feasibility study has been developed to reduce energy needs of DSM through use of self-regulation strategies delivered in real-time, in the real-world setting. Twenty-six AA women will receive personalized diabetes education over two days. They will be given a personalized activity prescription and a Fitbit wrist activity monitor. During the following two weeks, they will get a personal continuous glucose monitor (CGM) and individualized "cue cards" for simple behaviors they can try when glucose levels are too high. The intervention is grounded in self-regulation theory, and targets core self-regulation components, including self-monitoring/assessment, mental contrasting of target values with actual values, and goal-setting/review. The aim for this application is to Determine the feasibility and acceptability of an ecological momentary intervention, consisting of continuous glucose monitoring, activity tracking, and personalized cue cards with behavioral choices (eating/activity) driven by the results of glucose levels. Impact: Real-time feedback on the effects of activity and eating behaviors will enable patients to make choices and see results immediately. Our intervention will offer low-income African-American women opportunities to enact behaviors in their momentary environment, and will encourage autonomous motivation for PA uptake, and improving blood glucose control. Findings from this study will have an important positive impact on our ability to create tailored, EMIs among low-income adults who have limited access to diabetes specialty care and education.
详细描述
All visits will take place at the University of Illinois at Chicago (UIC) College of Nursing Clinical Diabetes and Exercise Laboratory. At time 1 (T1), participants will complete baseline assessments. Participants will complete health and biological assessments, including measures of glucose control (A1C), body mass index (BMI) and a diabetes health history, including, diabetes knowledge, and current DSM behaviors. The investigators will collect assessments of autonomous motivation, diabetes distress, depression, self-efficacy for diabetes self-care, and neighborhood related stress at baseline (T1) and upon completion of the 6-week intervention at time 2 (T2).
Intervention Week 1. Education and Fitbit set-up/instructions. The women will begin the intervention as soon as five women are enrolled and T1 assessments are completed. The investigators chose the group setting for the education to encourage social interaction and support, which has been associated with DSM in a similar population to ours. The education will consist of two 2-3-hour blocks of interactive diabetes education that will be personalized in response to the cluster members' DM knowledge, health, and self-care history. Education will follow the 2017 National Standards for Diabetes Self-Management and Support. Education sessions will be culturally adapted to reflect needs of AA participants, including feelings of powerlessness, access to care and family roles. Dr. Fritschi (PI) is a certified diabetes educator (CDE) and has worked with low-income, urban diabetes patients since 1994. She will adapt and deliver the education.
Session 1 (2-3 hours): Diabetes self-management education (DSME) will include target glucose ranges, medications, foot care, and dietary and exercise effects on glucose levels.
Session 2 (2-3 hours): At the start of the session, subjects will be given a wrist-worn activity tracker (Fitbit Charge 3 accelerometer) that will be able to assess real-time steps and heart rate. The Fitbit will also be able to track specific activities (e.g., cycling, yoga) that the participant may choose to track. Participants will be taught how to download the Fitbit app into their smart phones and set up personal accounts. The Fitbit Charge 3 was chosen because it has a larger screen and easier app than other devices, and Co-investigator Dr. Ulf Bronas has used the Fitbit extensively in his prior research. Group education will include interactive, hands-on learning about performing foot checks prior to walking; stretching exercises; and creative methods for accumulating steps when the weather or environment doesn't permit walking outside. Participants will individually meet with the exercise physiologist (Dr. Bronas) for a practical educational session using a treadmill-walking bout to determine heart rate goals for moderate and brisk walking. They will be given a written, personalized exercise plan for steps and target heart rate. The group will be coached in setting SMART (specific, measurable, achievable, relevant, and time-bound) goals for the following week. The goals may include Fitbit data, such as goals for step counts, stairs climbed, or minutes of activity.
The Fitbit is a cost-effective wrist-worn activity tracker that is commercially available. Fitbit data provide information on daily level of physical activities and heart rate. Measures include number of steps taken, four levels of activity (sedentary, light, moderate, and moderate-vigorous), distance traveled, and an activity score. Fitbits have been shown to be reliable and valid for step counts and total daily energy expenditure in free-living conditions. The advantages of using a Fitbit tracker are its cost-effectiveness and its ability to measure walking unobtrusively. The investigators are using it as a motivator and an option for individuals to set activity goals. Because patients are more likely to wear the Fitbit continuously, There will be fewer missing data, and activity bouts can be tracked.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •African American/Black female
- •History of T2DM > 1 year
- •Age > 40 years of age
- •On non-insulin anti-diabetic therapy or diet-controlled
- •Smartphone owner
排除标准
- •Women with type 1 diabetes
- •Women using insulin
- •Any condition that would prohibit the ability to walk for 15-30 minutes or participate in light to moderate physical activity
- •Low cognitive function (Mini-cog <3)
- •A1c > 10%
结局指标
主要结局
Number of times participants accessed their CGM data
时间窗: Post-intervention at week 6
Total number of times the CGM receiver was used to access glucose readings by the participants each day.
Interrelationships between real-time interstitial glucose levels (mg/dL) and activity levels (active minutes (correlation coefficients).
时间窗: Post intervention at week 6
Correlations between averaged daily glucose levels and average daily active minutes.
Wear time of Fitbit activity monitor
时间窗: Post-intervention at week 6
Assessment of wear time will include average hours per day the device was worn.
Interrelationships between real-time interstitial glucose levels (mg/dL) and activity levels (step counts).
时间窗: Post intervention at week 6
Correlations between averaged daily glucose levels and average daily step counts.
Hours of CGM data
时间窗: Post-intervention at week 6
Total number of hours of usable CGM data while worn.
Acceptability of intervention: Semi-structured Diabetes Study Acceptability Interview Guide
时间窗: Post-intervention at week 6
Semi-structured Diabetes Study Acceptability Interview Guide (developed by investigators). Open-ended questions will address: Overall experience; experiences with personalized education; helpfulness of group setting; Difficulty using devices, helpfulness of devices; interference with daily life; and any thoughts or suggestions for changes to the intervention.
次要结局
未报告次要终点
研究者
Cynthia Fritschi, PhD
Associate Professor
University of Illinois at Chicago
