Improving Health Outcomes in African Americans With Type 2 Diabetes: A Culturally Tailored, Resilience-Based Diabetes Self-Management Education (RB-DSME) Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 284
- 试验地点
- 2
- 主要终点
- Change from baseline in glycosylated hemoglobin (A1C) at 6 months
研究概览
简要总结
African Americans are twice as likely to have type 2 diabetes as non-Hispanic Whites and are less likely to engage in effective diabetes self-management. There is a critical need for intensive lifestyle interventions that address the distress inherent in having the disease and the unique stressors faced by African Americans that may worsen diabetes-related health outcomes. Our program, Resilience-Based Diabetes Self-Management Education and Support, integrates resilience resources with diabetes self-management skills to enable African-American patients to manage the daily demands of the disease and improve long-term adherence to healthy lifestyle choices, thereby reducing the negative health burden of diabetes.
详细描述
Type 2 diabetes mellitus (T2DM) costs the U.S. $327 billion annually, representing a 26% increase from 2012 to 2017. African Americans (AAs) are twice as likely to have T2DM as non-Hispanic Whites, have worse health outcomes, and are less likely to engage in self-management behaviors. Interventions addressing these disparities are urgently needed. Among AAs, T2DM-associated stress is often compounded by general life stress, which further constrains diabetes self-management and is associated with poor glucose control (A1C) and complications such as depression. The impact of stress on diabetes self-management and health outcomes may be attenuated by resilience: a resolve to succeed despite adversities. Even with evidence supporting resilience resources benefiting other health outcomes, there is a dearth of evidence-based T2DM resilience interventions. Building on our promising pilot work, this study uses our culturally tailored, theory-derived Resilience-Based Diabetes Self-Management Education (RB-DSME) intervention to help participants manage the psychosocial and behavioral demands of the disease. The study is designed as a 24-month, 2-arm, cluster non-randomized clinical trial and involves assigning AA churches to the RB-DSME or a standard DSME condition. Both groups receive a 10-month intervention: 8 weekly educational sessions, followed by 8 bimonthly support group sessions, followed by 2 booster sessions. To investigate the efficacy of RB-DSME, we compare RB-DSME to DSME on T2DM physical and mental health outcomes. To inform more targeted future interventions, we examine indirect effects of RB-DSME (vs DSME) on resilience resources, such as stress and coping. We also examine indirect effects of resilience resources on T2DM health outcomes through self-management behaviors, such as diet and exercise.
The specific aims of the study are:
Aim 1: To compare T2DM physical health outcomes (primary outcome: A1C) and T2DM mental health outcomes (primary outcome: depressive symptoms) in the RB-DSME group vs DSME group at 6, 12, and 24 months.
H1: Compared with DSME, RB-DSME will have improved T2DM physical health outcomes.
H2: Compared with DSME, RB-DSME will have improved T2DM mental health outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
All study participants receive a behavioral intervention that is aimed at managing their diabetes condition, either a standard diabetes self-management education intervention or the experimental resilience-based diabetes self-management education intervention. Due to the nature of behavioral interventions, we are only able to mask the participants, care providers, and dietary recall outcome assessors.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must:
- •be African American;
- •be diagnosed with T2DM;
- •be 18 years of age or older;
- •have an A1C of 6.5 or higher; and
- •not be currently participating in another T2DM management program.
排除标准
- •Individuals will be excluded if they:
- •are pregnant/lactating;
- •have medical conditions for which changes in diet and/or physical activity would be contraindicated (e.g., hospitalization for heart disease during the past 6 months, diagnosed heart failure, kidney failure, or peripheral vascular disease requiring special diets and/or restricted physical activity severe enough to preclude walking three times per week, or active tuberculosis); or
- •use glucocorticoid containing medication.
研究组 & 干预措施
Resilience-Based Diabetes Self-Management Education
The RB-DSME structure involves 8 weekly classes, 8 bimonthly support group sessions, and 2 booster sessions. The RB-DSME builds on foundational resilience resources (e.g., self-efficacy, social support), infusing novel resilience resources (e.g., adaptation to stress, finding positive meaning, spiritual coping) into the RB-DSME curriculum.
干预措施: Resilience-Based Diabetes Self-Management Education (Behavioral)
Standard Diabetes Self-Management Education
The scope and sequence of the standard diabetes self-management education (DSME) curriculum are aligned with national standards of the American Diabetes Association. DSME groups receive a 10-month intervention: 8 weekly educational sessions, followed by 8 bimonthly support group sessions, followed by 2 booster sessions.
干预措施: Standard Diabetes Self-Management Education (Behavioral)
结局指标
主要结局
Change from baseline in glycosylated hemoglobin (A1C) at 6 months
时间窗: Baseline and 6 months
Glycosylated hemoglobin (A1C) provides a 3-month average of blood glucose levels and is used to determine changes in blood glucose levels over time. A blood sample is obtained through finger prick capillary blood collection and measured using the A1C Now Self Check (PTS Diagnostics, Indianapolis, IN). The A1C Now Self Check is a commercially available kit designed for home use and requires a finger prick similar to testing blood glucose with a handheld glucometer. The kit is a National Glycohemoglobin Standardization Program certified test that provides results in 5 minutes.
Change from baseline in depressive symptoms at 12 months
时间窗: Baseline and 12 months
The primary mental health outcome, Depressive Symptoms, is measured with the Patient Health Questionnaire-9 (PHQ-9; Cronbach's alpha reliability = .86), which measures the frequency and severity of depressive symptoms. The scale contains 9 items, each of which is rated on a 0-3 scale; higher scores indicate higher levels of depression.
Change from baseline in glycosylated hemoglobin (A1C) at 24 months
时间窗: Baseline and 24 months
Glycosylated hemoglobin (A1C) provides a 3-month average of blood glucose levels and is used to determine changes in blood glucose levels over time. A blood sample is obtained through finger prick capillary blood collection and measured using the A1C Now Self Check (PTS Diagnostics, Indianapolis, IN). The A1C Now Self Check is a commercially available kit designed for home use and requires a finger prick similar to testing blood glucose with a handheld glucometer. The kit is a National Glycohemoglobin Standardization Program certified test that provides results in 5 minutes.
Change from baseline in glycosylated hemoglobin (A1C) at 12 months
时间窗: Baseline and 12 months
Glycosylated hemoglobin (A1C) provides a 3-month average of blood glucose levels and is used to determine changes in blood glucose levels over time. A blood sample is obtained through finger prick capillary blood collection and measured using the A1C Now Self Check (PTS Diagnostics, Indianapolis, IN). The A1C Now Self Check is a commercially available kit designed for home use and requires a finger prick similar to testing blood glucose with a handheld glucometer. The kit is a National Glycohemoglobin Standardization Program certified test that provides results in 5 minutes.
Change from baseline in depressive symptoms at 6 months
时间窗: Baseline and 6 months
The primary mental health outcome, Depressive Symptoms, is measured with the Patient Health Questionnaire-9 (PHQ-9; Cronbach's alpha reliability = .86), which measures the frequency and severity of depressive symptoms. The scale contains 9 items, each of which is rated on a 0-3 scale; higher scores indicate higher levels of depression.
Change from baseline in depressive symptoms at 24 months
时间窗: Baseline and 24 months
The primary mental health outcome, Depressive Symptoms, is measured with the Patient Health Questionnaire-9 (PHQ-9; Cronbach's alpha reliability = .86), which measures the frequency and severity of depressive symptoms. The scale contains 9 items, each of which is rated on a 0-3 scale; higher scores indicate higher levels of depression.
次要结局
- Change from baseline in physical activity at 6 months(Baseline and 6 months)
- Change from baseline in dietary intake at 6 months(Baseline and 6 months)
- Change from baseline in fasting blood glucose levels at 6 months(Baseline and 6 months)
- Change from baseline in cholesterol levels at 12 months(Baseline and 12 months)
- Change from baseline in cholesterol levels at 24 months(Baseline and 24 months)
- Change from baseline in physiological stress (HPA axis function) at 6 months(Baseline and 6 months)
- Change from baseline in physiological stress (HPA axis function) at 12 months(Baseline and 12 months)
- Change from baseline in fasting blood glucose levels at 12 months(Baseline and 12 months)
- Change from baseline in diabetes self-care at 6 months(Baseline and 6 months)
- Change from baseline in diabetes self-care at 12 months(Baseline and 12 months)
- Change from baseline in waist circumference at 24 months(Baseline and 24 months)
- Change from baseline in dietary intake at 12 months(Baseline and 12 months)
- Change from baseline in fasting blood glucose levels at 24 months(Baseline and 24 months)
- Change from baseline in triglycerides at 6 months(Baseline and 6 months)
- Change from baseline in body mass index (BMI) at 6 months(Baseline and 6 months)
- Change from baseline in blood pressure at 24 months(Baseline and 24 months)
- Change from baseline in sleep quantity and quality at 6 months(Baseline and 6 months)
- Change from baseline in physical activity at 12 months(Baseline and 12 months)
- Change from baseline in cholesterol levels at 6 months(Baseline and 6 months)
- Change from baseline in diabetes distress at 24 months(Baseline and 24 months)
- Change from baseline in finding positive meaning at 12 months(Baseline and 12 months)
- Change from baseline in triglycerides at 12 months(Baseline and 12 months)
- Change from baseline in triglycerides at 24 months(Baseline and 24 months)
- Change from baseline in body mass index (BMI) at 12 months(Baseline and 12 months)
- Change from baseline in body mass index (BMI) at 24 months(Baseline and 24 months)
- Change from baseline in waist circumference at 6 months(Baseline and 6 months)
- Change from baseline in waist circumference at 12 months(Baseline and 12 months)
- Change from baseline in diabetes distress at 12 months(Baseline and 12 months)
- Change from baseline in general perceived stress at 12 months(Baseline and 12 months)
- Change from baseline in general perceived stress at 24 months(Baseline and 24 months)
- Change from baseline in spiritual coping at 12 months(Baseline and 12 months)
- Change from baseline in adaptive coping strategies at 12 months(Baseline and 12 months)
- Change from baseline in blood pressure at 6 months(Baseline and 6 months)
- Change from baseline in blood pressure at 12 months(Baseline and 12 months)
- Change from baseline in general perceived stress at 6 months(Baseline and 6 months)
- Change from baseline in self-efficacy at 6 months(Baseline and 6 months)
- Change from baseline in finding positive meaning at 6 months(Baseline and 6 months)
- Change from baseline in adaptation to stress at 12 months(Baseline and 12 months)
- Change from baseline in diabetes distress at 6 months(Baseline and 6 months)
- Change from baseline in sleep quantity and quality at 12 months(Baseline and 12 months)
- Change from baseline in spiritual coping at 6 months(Baseline and 6 months)
- Change from baseline in self-efficacy at 12 months(Baseline and 12 months)
- Change from baseline in adaptive coping strategies at 6 months(Baseline and 6 months)
- Change from baseline in adaptation to stress at 6 months(Baseline and 6 months)
- Change from baseline in coping with discrimination at 6 months(Baseline and 6 months)
- Change from baseline in coping with discrimination at 12 months(Baseline and 12 months)
- Change from baseline in emotional regulation at 6 months(Baseline and 6 months)
- Change from baseline in emotional regulation at 12 months(Baseline and 12 months)
- Change from baseline in social support at 6 months(Baseline and 6 months)
- Change from baseline in social support at 12 months(Baseline and 12 months)
研究者
Mary Steinhardt
Principal Investigator (MPI)
University of Texas at Austin